Hematologic Disease Site

Hematologic

ID Sort	Study Title	Status Sort
ALC8 (MM1YA-S01)	A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) VS (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by myeloMATCH; A MYELOMATCH Clinical Trial Read More Complexity Level: 1 Eligibility: -Must register to the Master Screening and Re-assessment Protocol, myeloMATCH MSRP. and be assigned to ALC.8 prior to registration. -Must have newly diagnosed, untreated AML. -Must have high-risk AML per ELN 2017 criteria. Participants with t-AML, AML evolving from an antecedent hemotologic disorder, or AML-MRC are eligible. Acute promyelocytic leukemia is excluded. -Participants with FLT3 mutations and t(9;22) translocation are excluded. -Ages 18-59, Zubrod Performance Status <= 3. -Adequate organ function (creatinine clearance >= 30 mL/min; AST/ALT < 3 x ULN; total bilirubin <= 2 x ULN; cardiac ejection function >= 50%) Objectives: ,Primary: Compare rates of measureable residual disease (MRD) negative complete remission between (1) cytarabine + daunorubicin, (2) cytarabine + daunorubicin + venetoclax, (3) azacitidine + venetoclax, (4) (cytarabine and daunorubicin) liposome and (5) (cytarabine and daunorubicin) liposome + venetoclax. Secondary: Estimate the frequency and severity of toxicities with each regimen. -Estimate CR, CRi with and without MRD, EFS, time to relapse, RFS, and OS in each regimen. -Describe and compare MRD negative CR rates by genomic subgroups within and across randomized arms. Banking: Bank specimens for future correlative studies. NCT Registration ID (from clinicaltrials.gov): NCT05554406 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Planned Chair: (Canada) Dr. Guillaume Richard-Carpentier, Princess Margaret Cancer Centre, (416) 946-4501 Ext. 5375	Planned
ALC9 (MM2YA-EA01)	Eradicating Minimal Residual Disease in patients with AML prior to Stem Cell Transplant (ERASE): A MyeloMATCH Treatment Trial Read More Complexity Level: 1 Eligibility: - Must register to the Master Screening and Re-assessment Protocol, myeloMATCH MSRP, and be assigned to ALC.9 prior to registration. - Must have completed induction chemotherapy in a MyeloMATCH Young Adult Tier-1 protocol. - Must have attained CR or CRh with detectable MRD, as assessed by MDNet. - Must have morphologically documented AML or secondary AML (from prior conditions such as MDS, MPN), or therapy-related AML. - Must not have FLT3 TKD or ITD mutation. - Ages 18-59, ECOG performance status 0-2. - Adequate organ and marrow function (ANC >= 500/mcL; Platelets >= 50,000 mcL; creatinine <= 1.5 x ULN 30 mL/min; AST/ALT <= 3 x ULN; total bilirubin <= 2 x ULN). Objectives: Primary: To improve the rate of MRD negative CR in patients with AML who achieved MRD positive CR after induction chemotherapy in a myeloMATCH Young Adult Tier-1 protocol. Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Planned Chair: (Canada) Dr. Lee Mozessohn, Odette Cancer Centre, (416) 480-5000 Ext. 5847	Planned
MD1 (MD.1)	CALMS: Combination Therapy with Luspatercept in Lower Risk MDS: A Non-Comparative, Parallel, Multi-Arm Phase 2 Study: A myeloMATCH Treatment Trial Read More Complexity Level: 2 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Planned Chair: (Canada) Dr. Rena Buckstein, Odette Cancer Centre, (416) 480-5000 Ext. 5847	Planned
AL6 (MM1YA-CTG01)	A Measurable Residual Disease (MRD) Focused, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients with Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH Clinical Trial Patients with previously untreated intermediate risk acute myeloid leukemia(AML) will receive either cytarabine+ daunorubicin+venetoclax or azactidine +venetoclax or cyctarabine+daunorubicin to determine which treatment results in complete responses in the highest percentage of patients. Read More Complexity Level: 2 Eligibility: Participants must have been registered to Master Screening and Re-Assessment Protocol (ALC.7-myeloMATCH MSRP) and assigned to this trial via MATCHBox prior to consenting to this study. Previously untreated, de novo AML defined by >20% myeloblasts in the peripheral blood or bone marrow excluding the following: favorable cytogenetics; CEBPA biallelic mutations; NPM1 mutation; AML with PML-RARa; AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1,11q23/KMT2 rearrangements; AML with FLT3-ITD or FLT3-TKD mutations; therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm - Age 18-59 at the time of induction therapy, ECOG performance status<= 3 Objectives: Primary: Compare the rates of undetectable MRD in patients who acheive a CR after induction therapy between the 7+3, 7+3+venetoclax and venetoclax+azacitidine Secondary: To estimate the frequency and severity of toxcities with each of the regimens To estimate CR and CRi rates(with or without MRD), EFS, RFS and OS in each regimen. Tertiary: Evaluate response to therapy received according to genomic findings. Evaluate MRD kinetics by following patients with detectable MRD through Tier 2 and beyond. - Evaluate longer term outcomes by treatment arm, genomics, MRD outcome and other features as patients receive additional myeloMatch therapies NCT Registration ID (from clinicaltrials.gov): NCT05554393 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: July 18, 2024 Chair: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, (514) 340-8207, (Canada) Dr. Mary Lynn Savoie, Tom Baker Cancer Centre, (403) 944-1564	Open to Accrual
ALC7 (MYELOMATCH)	MYELOMATCH, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI MYELOMATCH Clinical Trials This screening study involves testing bone marrow and blood of participants with AML or MDS for certain biomarkers that specific drugs can target. The biomarker testing will show if participants can be assigned to a myeloMATCH treatment study or can be assign to receive standard of care (SOC) treatment under the care of their doctor. Each myeloMATCH treatment study is a clinical trial that tests treatment for myeloid cancer. Read More Complexity Level: 3 Eligibility: Participants must be ≥ 18 years of age and be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). For participants assigned an AML basket protocol, there cannot be a history of previous myeloproliferative neoplasms (MPN) or MDS. No have a prior or concurrent malignancy that requires concurrent anti-cancer therapy. Participants must have agreed to specimens submitted and offered the opportunity to participate in banking. Objectives: Primary: a.Screening and Reassessment (MSRP): To evaluate the feasibility of MATCHBox receiving and organizing all data needed for assignment to a myeloMATCH clinical trial or Tier Advancement Pathway (TAP) within 72 hours of MDNet receipt of all required specimens for initial therapy and within 10 days for subsequent therapy. b. TAP: To enable participants who are not matched to an investigational myeloMATCH treatment substudy to receive standard of care (SOC) while remaining on the MSRP to maintain access to later tiers of treatment substudies. See protocol for secondary objectives. NCT Registration ID (from clinicaltrials.gov): NCT05564390 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: May 29, 2024 Chair: (Canada) Dr. Aly Karsan, BCCA - Vancouver Cancer Centre, (604) 877-6248	Open to Accrual
CLC3 (SWOG S1925)	Randomized Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus DeLayed Therapy with VEnetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study Read More Complexity Level: 2 Eligibility: Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) diagnosed withing 12 months prior to registration. Must have CLL-International Prognostic Index Score greater or equal to 4 and/or complex cytogenics. Cytogenic and FISH analyses within 12 months prior to registration. TP53 mutation status if done completed within 12 months prior to registration. IgVH status obtained prior to registration. Serum beta-2 microglobulin level obtained within 28 days prior to registration. Must not meet any of the IWCLL specified criteria for active CLL therapy. Objectives: Primary: To evaluate whether early treatment with venetoclax and obinutuzumab (V-O) extends overall survival (OS) compared with delayed treatment with V-O in high-risk (chronic lymphocytic leukemia [CLL] international prognostic indicator [CLL-IPI] .4 or complex cytogenetics), newly diagnosed asymptomatic CLL/SLL patients. Secondary: Compare overall response rate between arms. To evaluate safety and tolerability of each arm. To compare time to second CLL-directed treatment between arms. To compare relapse-free survival (RFS) and time to second objective disease response. To compare rates of Richter's transformation between arms. To describe Cumulative Illness Rating Scale across the study, in each treatment arm and to estimate the interaction between the scale and treatment and OS. Teritary: To assess impact of early intervention with V-O versus delayed therapy with V-O in CLL patients to HRQoL using FACT-Leukemia. Additional correlative objectives NCT Registration ID (from clinicaltrials.gov): NCT04269902 Participation: Limited to invited centres; Site Selection Open NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: December 23, 2021 Chair: (Canada) Dr. Versha Banerji, CancerCare Manitoba, (204) 787-4904	Open to Accrual
CLC3E	An Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Companion Analysis to CCTG CLC.3/SWOG 1925 Randomized Phase III Clinical Trial This study is investigating the cost-utility ratio between the early approach and delayedd approach arms of the CLC.3 main study for a Canadian health care perspective. Read More Complexity Level: 3 Eligibility: Participants who are eligible for the core CLC.3 study are eligible and included in the CLC.3E sub-study Objectives: Primary: To determine the incremental cost-utility ratio of an early novel therapy approach (venetoclax-obinutuzumab) compared to a deferred approach in Canadian patients with high-risk CLL. Direct medical costs will be estimated from the perspective of the Canadian public healthcare system. The denominator of the ratio will be expressed in quality-adjusted life years gained. Secondary: To determine the incremental cost-effectiveness ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL (enrolled in the randomized component of the SWOG S1925/CLC3 study). Effectiveness will be expressed in life years gained and years to second progression gained. To determine direct medical costs of care, to compare change in health preference (utility) over time, and to compare the lost productivity for Canadian individuals with high-risk CLL. NCT Registration ID (from clinicaltrials.gov): NCT05371808 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: May 10, 2022 Chair: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, (416) 480-5000 Ext. 4757	Open to Accrual
HD11	A Randomized Phase II Trial of Pembrolizumab and Brentuximab Vedotin versus GDP Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma This is an open label, multi-centre, randomized phase II trial of novel combination therapy followed by autologous stem cell transplantation in patients with relapsed and refractory classical Hodgkin lymphoma, conducted by the CCTG with support of Merck and Seattle Genetics. The trial will compare standard gemcitabine, dexamethasone, and cisplatin (GDP) versus pembrolizumab and brentuximab as salvage therapy prior to transplant. FDG-PET review performed locally to assess response and then central review to be performed at the end of study Read More Complexity Level: 2 Eligibility: Patients 18 years and up must have had a history of classic Hodgkin lymphoma by histopathology and have relapsed or refractory disease after anthracycline-containing chemotherapy. Patients must have ECOG performance of 0-1 and are eligible for high dose chemotherapy and autologous stem cell transplant. No prior salvage systemic therapy for relapsed/refractory disease. No history of peripheral neuropathy or dyspnea > grade 2, active CNS disease, cerebral vascular event, progressive multifocal leukoencephalopathy (PML), (non-infectious) pneumonitis requiring steroids, HIV, nor other malignancies (with exceptions). No diagnosis of immunodeficiency, no active autoimmune disease requiring treatment in past 3 years. No active Hepatitis C or B infection or any uncontrolled active systemic infection. No clinically significant cardiovascular disease. Any serious active disease or co-morbid medical condition. No live vaccination. No allogenic tissue/solid organ transplant. No RT within 14 days. Objectives: Primary:To determine the complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy. Secondary: PFS, EFS, OS, successful stem cell collection rate, transplantation rate, toxicity and safety, patient reported quality of life, health economics including patient reported financial toxicity and cost per quality adjusted life years Exploratory: To identify markers of disease response and/or tumour biology that provide prognostic or predictive information, to evaluate PET radiomic parameters beyond those identified in the Lugano 2014 response criteria, and to evaluate response and outcome using the RECIL and LYRIC criteria NCT Registration ID (from clinicaltrials.gov): NCT05180097 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: March 03, 2022 Chair: (Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2641, (Canada) Dr. John Kuruvilla, University Health Network, (416) 946-2827	Open to Accrual
HD12 (RADAR)	A Randomized Phase III Trial with a PET Response Adapted Design Comparing ABVD +/- ISRT with A2VD +/- ISRT in Patients with Previously Untreated Stage IA/IIA Hodgkin Lymphoma (RADAR) The HD.12/RADAR study is for patients diagnosed with previously untreated stage IA/IIA Hodgkins Lymphoma. The purpose of the study is to answer the following question: Will replacing one of the drugs in the usual treatment with a drug called brentuximab vedotin a) improve cure rates and/or b) reduce side effects during treatment and later in life? Read More Complexity Level: 2 Eligibility: Patients, 16-69 years old and have histologically confirmed stage I or II classical Hodgkin lymphoma with no mediastinal bulk disease or B symptoms. Patients must have ECOG status of 0 to 2.with no prior treatment for Hodgkin lymphoma, but are fit to receive anthracycline-based chemotherapy. Patient must have the following lab values: creatinine clearance >40 ml/min, total bilirubin <1.5 x ULN, ALT or AST <2 x ULN, haemoglobin > or equal to 8g/dL, neutrophils > or equal to 1.0 x109/l, and platelets > or equal to 100 x109/l. Patients may not have nodular lymphocyte Hodgkin lymphoma, pre-existing grade > or equal to 1 sensory or motor peripheral neuropathy, symptomatic neurologic disease, history of progressive PML, significant cardiovasular or respiratory disease, serious active disease or co-morbid medical condition, uncontrolled active systemic infection, HIV, hepatitis C, or active hepatitis B. No other cancer (with exception), recurrent, or persistent cancer within last 5 years. Objectives: Primary objective: To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves progression free survival (PFS) Secondary objectives: To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves PET CMR rates To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves event-free survival (EFS) To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) has an effect on overall survival (OS) NCT Registration ID (from clinicaltrials.gov): NCT04685616 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: August 08, 2023 Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567	Open to Accrual
I244	A Phase 2 Study of Ibrutinib Combination Therapy in Transplant Ineligible Individuals with Newly Diagnosed Primary Central Nervous System Lymphoma The purpose of this study is to test the good and bad effects of the drug called ibrutinib in patients with newly diagnosed primary central nervous system lymphoma. Each of the first 6 cycles of treatment will be 14 days long, and patients will receive methotrexate and rituximab (where available) on the first day of each cycle and ibrutinib on days 6-14 of each cycle. In cycle 7 onwards each cycle of treatment will be 28 days, and patients will take ibrutinib every day. Treatment will continue for two years from the first drug administration or until the patient’s disease progresses, whichever comes first. The study doctors hope to learn if adding ibrutinib to the usual treatment of methotrexate and rituximab will increase the number of patients whose cancer does not worsen after one year. Read More Complexity Level: 1 Eligibility: Patients (≥18 y/o, ECOG PS 0-2, 3 if due to PCNSL & expected to reverse with treatment) must have histological/cytological evidence of PCNSL; vitreo-retinal/CSF disease eligible with CNS involvement on MRI. No 2° CNS non Hodgkin lymphoma or significant 3rd space fluid which can’t be drained. Must be ineligible for high-dose chemo & ASCT, fit to receive protocol Tx. Consent to release tumour block. No prior radiation/systemic Tx except corticosteroids for PCNSL. ≤ 8mg/day of dexamethasone (or equivalent) at enrolment & wean within 7 days of starting Tx. Major surgery ≥28 days before enrolment (unless for PCNSL) & wounds healed. Able to swallow oral meds, no known GI impairment. No active Tx for other advanced/metastatic malignancy. No serious illnesses/medical conditions precluding management per protocol, no clinically significant cardiac disease (pts with history of cardiac disease: LVEF ≥50%). No anticoagulation with warfarin/equivalent or strong CYP3A inhibitor/inducer. Objectives: Primary: One year progression-free survival (PFS). Secondary: Overall Response Rate (ORR = CR+CRu+PR) and complete response (CR) rate; 1-year event-free survival (EFS); 2-year PFS; Overall survival (OS); To determine the safety and tolerability of ibrutinib, methotrexate, and rituximab treatment in patients with primary central nervous system lymphoma (PCNSL); To determine the impact on patient related outcomes of ibrutinib, methotrexate, and rituximab treatment in patients with PCNSL - Cognitive functioning, Health-related quality of life (FACT-BR) and cognitive symptoms (FACT-Cog). Tertiary: Baseline and serial plasma and cerebrospinal fluid circulating tumour DNA, correlated with outcomes; Radiomic evaluation of predictors of disease response and relapse NCT Registration ID (from clinicaltrials.gov): NCT05998642 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: October 24, 2023 Chair: (Canada) Dr. Jean-Francois Larouche, CHU de Quebec-Hopital l'Enfant-Jesus (HEJ), (Canada) Dr. Anca Prica, University Health Network, (416) 946-4501 Ext. 2249	Open to Accrual
LY17	A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma This is an unblinded (open-label) multi-centre randomized phase II trial of novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma, conducted by CCTG. The trial will open as a two arm comparison of Ibrutinib plus Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (R-GDP) versus R-GDP alone, and will add a third arm of Rituximab plus dose-intensive cyclophosphamide, etoposide, and cisplatin (R-DICEP). The primary endpoint for the trial is overall response rate. Up to sixty-four patients will be accrued to each arm, with interim analyses scheduled when 16 and 32 patients have been enrolled. Individuals will be randomly assigned to initial therapy. Those with responsive disease will go on to receive autologous stem cell transplant (ASCT). The purpose of this randomized phase II "pick the winner" design is to facilitate efficient screening of novel combination treatment regimens and select those meeting pre-specified criteria for testing in the phase III setting. This study will also allow us to evaluate the predictive value of a number of biomarkers Read More Complexity Level: 2 Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as transformed previousl indolent lymphoma and unclassifiable B-cell lymphoma), with clinically and/or radiologically measureable disease. Patients must be 16 years old or older, must have had at least one previous regimen of therapy for their disease, and must be considered fit for intensive chemotherapy and ASCT. Patients must have a life expectancy of >90 days, and a performance status of 3 or less. Specific laboratory requirements also apply. Objectives: To determine the overall response rate (complete and partial response) to novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma. NCT Registration ID (from clinicaltrials.gov): NCT02436707 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: May 05, 2015 Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567, (Canada) Dr. John Kuruvilla, University Health Network, (416) 946-2827	Open to Accrual
LY18	A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma This is an unblinded (open-label) multi-centre phase I trial of novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma, conducted by the CCTG. The study will open with one cohort. Additional cohorts may be added in future as separate appendices, through protocol amendment. There will be no randomization. Read More Complexity Level: 2 Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at most recent relapse, with clinically and/or radiologically measureable disease. Patients with de novo aggressive B-cell lymphoma must have relapsed or progressed, or have biopsy proven refractory disease, after one prior line of therapy (R-CHOP chemotherapy or equivalent). Patients with histological transformation from low-grade lymphoma may have had up to 3 prior treatment regimens. Patients with transformed low grade lymphoma treated with a non-anthracycline regimen may be enrolled at investigator discretion Patients must be 16 years old or older, must be an appropriate candidate to receive second-line salvage chemotherapy, and must be considered fit for intensive chemotherapy and ASCT. Objectives: The primary objective is to establish the recommended phase II dose of new combination therapy in individuals with relapsed and refractory lymphoma. Secondary objectives include determining the overall response rate using RECIL and Lugano response criteria, evaluating the tolerability and toxicity, determining the stem cell collection rate and transplantation rate, and determine overall survival and event free survival. An exploratory objective is to assess molecular factors, which may be prognostic or predictive of response. NCT Registration ID (from clinicaltrials.gov): NCT04161248 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 06, 2019 Chair: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, (514) 340-8207	Open to Accrual
MY13	A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration versus Continuous Daratumumab Among Transplant Ineligible Older Adults with Newly Diagnosed Multiple Myeloma This randomized phase III trial studies whether daratumumab treatment can end once myeloma patients have received its maximum benefit without reducing disease control provided by their remaining treatment. Read More Complexity Level: 2 Eligibility: Newly-diagnosed, transplant ineligible multiple myeloma, meets measurable disease criteria (Serum M-protein >=5 g/L; urine M-protein >=200 mg/24 hrs; if abnormal serum free light chain ratio, serum free light chain >=100 mg/L; for IgA patients, qIgA >=750 mg/dL), received daratumumab-lenalidomide-dexamethasone (dara-len-dex) for 18-20 cycles with >=partial response per IMWG criteria, ECOG performance status 0-3. Objectives: Primary objective is to evaluate non-inferiority in progression-free survival for fixed versus continuous duration dara in patients already receiving dara-len-dex treatment. Secondary objectives: Comparing between fixed and continuous duration dara arms i) overall survival, ii) proportion of patients with a very good partial response to treatment or better, iii) the incidence of treatment-related grade 3 through 5 adverse events, iv) the time to next treatment, v) post protocol therapy, vi) quality of life, and vii) health economics NCT Registration ID (from clinicaltrials.gov): NCT06182774 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 08, 2023 Chair: (Canada) Dr. Hira Mian, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495	Open to Accrual
MYC2 (SWOG S1803)	A Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) Testing the addition of a new drug, subcutaneous daratumumab, to the usual treatment (lenalidomide) as post-stem cell transplant treatment for multiple myeloma Read More Complexity Level: 2 Eligibility: STEP 1 (Study Entry) - (1) Confirmed diagnosis of symptomatic multiple myeloma that required systemic induction therapy prior to stem cell transplant (ASCT). (2) No organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction. (3) No prior progressive disease. (4) Refractory to or intolerant to either lenalidomide or daratumumab/rHuPH20 (5) Must have initiated induction therapy within 12mo prior to reg Step 1 (at least 2 cycles therapy). (6) over 18 under 75 years of age, physical exam, Zubrod 2 or less, adequate renal and liver function (7) mandatory had/will have standard stem cell transplant (8) - STEP 2 (Rand 1: Post ASCT/Pre-Maintenance) - (1) ASCT within 180 days and no maintenance therapy and no progressive disease (2) scan for disease assessment (3) adequate hepatic and renal function - STEP 3 (Rand 2: post 2yr main) (1) completed 24 cycles of maintenance lenalidomide or lenalidomide+dara (2) be 24mo MRD neg in very good partial remission. Objectives: Primary objective: To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients. Secondary objectives: Overall Response Rate (ORR), Progression-Free Survival (PFS), Evaluate MRD-negativity between arms, compare toxicity and tolerability of long term therapy between arms. Compare OS between MRD negative patients between groups. Additional objectives: To report the findings of the 24-month MRD analysis as early as 24 months after all patients have been accrued. NCT Registration ID (from clinicaltrials.gov): NCT04071457 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: April 11, 2022 Chair: (Canada) Dr. Christopher Venner, BCCA - Vancouver Cancer Centre	Open to Accrual
ALC6 (ALLIANCE A041501)	A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (A Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL Read More Complexity Level: 1 Eligibility: Patients who are 18 to 39 years old and are newly diagnosed with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible for this study. Patients with Burkitt type ALL or who have BCR-ABL fusion transcript determined by FISH or RT-PCR or t(9;22)(q34;q11) by cytogenetics are not eligible. No prior therapy is allowed for ALL except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. Patients must complete remission induction therapy and have M2 marrow or better by the time of randomization. Objectives: To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS), without censoring for transplant. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response.To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved, with censoring for transplant.To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.To determine the prognosis based on patients' LDA gene signature. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the regimen used in CALGB 10403. NCT Registration ID (from clinicaltrials.gov): NCT03150693 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: On Hold Activation Date: April 12, 2019 Chair: (Canada) Dr. Jill Fulcher, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 71284	On Hold
AL5 (DFCI 06-254)	Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial Read More Complexity Level: 1 Eligibility: Eligibility: All adults aged 18 to 50 years with newly diagnosed ALL will be eligible for this protocol. Patients with ALL-L3 will not be eligible for this study. Objectives: Primary: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. The primary endpoint of this study is the feasibility of the intensification therapy, measured as the percentage of patients who, having achieved a CR after induction therapy, receive more than 25 weeks of IV PEG asparaginase as part of intensification therapy. To explore the relative toxicity of IV PEG asparaginase. To explore the relative efficacy and toxicity of adding imatinib to multiagent chemotherapy for patients with Philadelphia-positive ALL. NCT Registration ID (from clinicaltrials.gov): NCT01005758 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: September 10, 2008 Closing Date: January 08, 2013 Chair: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, (514) 252-3400 Ext. 3404	Closed to Accrual
ALC4 (ECOG E1910)	A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults. Read More Complexity Level: 1 Eligibility: Adults aged 30-70 years with confirmed new diagnosis of BCR-ABL negative, B-lineage ALL. Objectives: Primary: to evaluate the overall survival associated with blinatumomab Secondary: minimal residual disease assessment; toxicities associated with treatment; outcome of blood/marrow transplant with or without blinatumomab; incidence of anti-blinatumomab antibody formation NCT Registration ID (from clinicaltrials.gov): NCT02003222 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: March 24, 2017 Closing Date: October 15, 2019 Chair: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, (514) 252-3400 Ext. 3404	Closed to Accrual
CLC2 (ALLIANCE A041202)	A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (> = to 65 years of age) with Chronic Lymphocytic Leukemia (CLL). Read More Complexity Level: 2 Eligibility: Intermediate or high-risk Rai stage chronic lymphocytic leukemia. Patients must be age 65 or older and have not received previous treatment for CLL. Objectives: To determine whether progression free survival (PFS) is superior after therapy with bendamustine in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated CLL NCT Registration ID (from clinicaltrials.gov): NCT01886872 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: February 05, 2015 Closing Date: May 01, 2016 Chair: (Canada) Dr. Carolyn Owen, Tom Baker Cancer Centre, (403) 521-3621	Closed to Accrual
CLC2E	A Prospective Economic Analysis of NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia Read More Complexity Level: 3 Eligibility: All Canadian patients registered to CLC.2 Objectives: To determine the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab. NCT Registration ID (from clinicaltrials.gov): NCT02414022 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Closed to Accrual Activation Date: March 13, 2015 Closing Date: May 01, 2016 Chair: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, (416) 480-5000 Ext. 4757	Closed to Accrual
HDC1 (SWOG S1826)	A Phase III Randomized Study of Nivolumab (Opdivo) or Brentuximab Vedotin (Adcetris) plus AVD in Patients (age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma Read More Complexity Level: 2 Eligibility: All patients must have histologically confirmed newly diagnosed, previously untreated Stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)). Nodular lymphocyte predominant Hodgkin Lymphoma is not eligible. Patients must have bidimensionally measurable disease (at least one lesion with longest diameter greater than or equal to 1.5 cm). Patients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. Pts. must be greater than or equal to 12 years of age. Objectives: Primary: To compare the PFS in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD versus that obtained with BV-AVD. Secondary:To compare OS, EFS, CR in pts rand. to N-AVD vs. BV-AVD and the safety and tolerability of N-AVD vs BV-AVD. To compare physician-reported treatment related AE rates b/w arms stratified by age. To compare pt reported symptoms using selected PRO-CTCAE items between arms stratified by age. NCT Registration ID (from clinicaltrials.gov): NCT03907488 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: December 08, 2020 Closing Date: December 01, 2022 Chair: (Canada) Dr. Kelly Davison, The Research Institute of the McGill University, (514) 934-1934 Ext. 31558, (Canada) Dr. Angela Punnett, The Hospital for Sick Children, (416) 813-5872, (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567	Closed to Accrual
LY12	A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation. Read More Complexity Level: 2 Eligibility: Patients to be included are those with a diagnosis of aggressive histology (B cell or T cell) non-Hodgkin's lymphoma whose disease is refractory to or relapsed after one prior first-line, anthracycline-containing chemotherapy regimen. Patients with CD20+ve B cell disease will be further evaluated after completion of protocol salvage treatment and autologous stem cell transplant (ASCT) for randomization to either maintenance rituximab or observation alone. Objectives: Randomization 1, Salvage Treatment [(R)-GDP vs (R)DHAP]. Primary: to compare response rates between the two salvage groups after two cycles of either (R)-GDP or (R)-DHAP; to compare the transplntation rate of the two salvage regimens. Secondary: to compare between the two arms event-free survival and overall survival, successful mobilization rates, quality of life, toxic effects, resource utilization, and medical/societal costs. Randomization 2, Maintenance (rituximab vs observation). Primary: to compare two-year event-free survival between the two maintenance groups. Secondary: to compare between the two arms two-year overall survival and toxic effects. NCT Registration ID (from clinicaltrials.gov): NCT00078949 Participation: Not limited. NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: August 07, 2003 Closing Date: December 31, 2012 Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567, (Italy) Prof. Massimo Federico, Gruppo Italiano Studio Linfomi (GISL), (59) 422-4383	Closed to Accrual
LY16 (LYSARC RELEVANCE)	A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma Read More Complexity Level: 2 Eligibility: Investigator-assessed diagnosis of Stage II-IV CD20+ follicular lymphoma (grade 1-3a) Objectives: Co-Primary: complete response (CR/CRu), progression free survival (PFS) Secondary: event free survival (EFS),time to next anti-lymphoma treatment (TTNLT, overall survival (OS), safety, Exploratory: CR rate at 120 weeks and PFS, time to treatment failure (TTF), time to next chemotherapy treatment (TTNCT) and overall response rate (ORR) at 120 weeks, biomarker analysis, health related QoL and health economics. NCT Registration ID (from clinicaltrials.gov): NCT01650701 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: June 17, 2013 Closing Date: November 10, 2014 Chair: (Canada) Dr. Laurie Sehn, BCCA - Vancouver Clinic, (604) 877-6000 Ext. 2736	Closed to Accrual
LYC1 (ECOG E1411)	Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -> R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -> R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB -> LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV -> LR) Read More Complexity Level: 2 Eligibility: Patients must have confirmed diagnosis of mantle cell lymphoma and must be greater than 18 years old. Objectives: Primary: progression free survival in induction and consolidation Secondary: PET document complete response rate, objective response rate, overall survival, safety NCT Registration ID (from clinicaltrials.gov): NCT01415752 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: March 12, 2014 Closing Date: September 09, 2016 Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567	Closed to Accrual
AL1	Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia Read More Eligibility: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma TNM Stage: Tx-4, N0-1, M0 Local radiographic reading consistent with resectable disease Measurable disease and/or non-measurable disease Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio Determined to be appropriate candidate for curative-intent pancreatectomy No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy or surgery for pancreatic cancer Not pregnant and not nursing Age >/= 18 years ECOG Performance Status 0-1 Total Neuropathy Score < 2 No known Gilbert's Syndrome or known homozygosity for UGATA1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors and/or inducers of CYP3A4 is not allowed. Objectives: Primary Objective is Overall Survival. Secondary Objectives: To evaluate and compare the following in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX: " disease-free survival (DFS) " time to locoregional recurrence (TLR) " time to distant metastases (TDM " R0 resection rate " rate of unresectability, " mFOLFIRINOX dose intensity delivered and number of cycles received " adverse event profile To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the EORTC QLQ-C30 between arms. To prospectively assess the influence of diet,BMI, weight loss, physical activity, and other lifestyle habits on DFS and OD among patients with localized pancreatic cancer. NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 07, 1981 Closing Date: June 08, 1982	Permanently Closed
AL2 (INT 0129)	Phase III Randomized Study of All-Trans Retinoic Acid versus Cytosine Arabinoside and Daunorubicin as Inductive Therapy for Patients with Previously Untreated Acute Promyelocytic Leukemia Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: August 01, 1992 Closing Date: February 01, 1995	Permanently Closed
AL3 (CALGB C9710)	Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia Read More Complexity Level: 1 Eligibility: Diagnosis of acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by RT-PCR assay. Prior treatment: No systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient. Non-pregnant, non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Patients should not become pregnant or plan to become pregnant while on treatment. Objectives: To compare the efficacy (event-free survival) and toxicities of two induction/consolidation therapies for patients with untreated APL: ATRA/ara-C/daunorubicin with or without arsenic trioxide (AS2O3). To evaluate the efficacy (disease-free survival) and toxicities of maintenance therapy with intermittent ATRA versus intermittent ATRA plus 6-MP/MTX for patients with APL who achieve a complete response. NCT Registration ID (from clinicaltrials.gov): NCT00003934 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: April 18, 2002 Closing Date: March 29, 2005	Permanently Closed
AL4 (DFCI 01-175)	A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol Read More Complexity Level: 1 Eligibility: Patients must have pathologically documented de novo acute lymphoblastc leukemia, excluding mature B-cell ALL, which is diagnosed by the presence of either surface immunoglogulin, L3 morphology or one of the following cytogentic abnormalities t(8;14)(q24;q32), t(8;22), or t(2;8). Objectives: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. To determine the safety and optimal dosing of L-asparaginase during the intensification period. To determine the pharmacokinetics of weekly E.coli L-asparaginase by evaluating serum asparaginase levels in all patients To determine the toxicity of individualized dosing of E.coli L-asparaginase based upon asparaginase levels To determine the prognostic significance of early response to induction chemotherapy within the context of our treatment program To evaluate the outcome of patients based upon bone marrow status after 15 days of multi-agent induction chemotherapy, comparing the outcome of patients with M3 status (>25% leukemia cells still present) at that time point versus those with M1/M2 status (<25% leukemia cells still present) or hypoplastic marrows. To evaluate the outcome of patients base NCT Registration ID (from clinicaltrials.gov): NCT00136435 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: January 24, 2005 Closing Date: February 21, 2008	Permanently Closed
ALC1 (S0106)	A Phase III Study Of The Addition Of Mylotarg® During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg® Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia Read More Complexity Level: 1 Eligibility: Patients must have a morphologically confirmed diagnosis of acute myeloid leukemia (AML) with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration. Objectives: -Compare DFS of patients under age 56 with previously untreated, de novo, non-M3, AML who receive Mylotarg as post-consolidation therapy versus patients who receive no post-consolidation therapy. -Compare CR rate achieved by the addition of Mylotarg to standard induction chemotherapy in patients under the age of 56 with previously untreated, de novo, non-M3 AML. The durability of complete response will also be measured. -Estimate the frequency and severity of toxicities of the addition of Mylotarg to induction therapy and post-consolidation therapy. -To evaluate the prognostic significance of CD33 expression on the response rate of patients who receive Mylotarg. -To evaluate the prognostic significance of FLT3 mutations and flow through cytometic detection prior to therapy, and of minimal residual disease in remission specimens collected before and after consolidation therapy and after post-consolidation therapy with Mylotarg. NCT Registration ID (from clinicaltrials.gov): NCT00085709 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: April 27, 2006 Closing Date: August 20, 2009	Permanently Closed
CL1 (9011)	A Phase III Comparison of Fludarabine Phosphate (NSC #312887) vs Chlorambucil vs Fludarabine Phosphate + Chlorambucil in Previously Untreated B-Cell Chronic Lymphocytic Leukemia Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: March 08, 1991 Closing Date: December 07, 1994	Permanently Closed
CL2	A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia Read More Eligibility: Patients with previously untreated B-cell chronic lymphocytic leukemia, requiring treatment. Submission of blood samples for immunophenotyping, FISH and PCR studies are a requirement for participation. Objectives: To determine overall (CR, PR) response rate. Secondary endpoints include assessment of molecular CR rate, toxicity, progression-free and treatment-free survival as well as determination of the incidence of defined genetic abnormalities in the study population. The prognostic and predictive significance of genetic abnormalities and immunophenotypic profile at the start of treatment, with respect to response to oral fludarabine, will be evaluated. NCT Registration ID (from clinicaltrials.gov): NCT00049075 Participation: Limited to centres expecting to accrue > 4 patients/year NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 08, 2002 Closing Date: January 30, 2004	Permanently Closed
CLC1E (CLC1E)	A Canadian Economic Analysis of CLC.1 Read More Complexity Level: 3 Eligibility: Tumour Type: CLL Line of Therapy: 1st line therapy Stage of Disease: Previously untreated, early-stage patients who are candidates for observation. Only patients included in the randomized portion of this trial (those with the poor-risk molecular marker) will be included in the Economic Analysis. Objectives: Primary: Time to 2nd treatment; The primary outcome of the economic analysis is cost-utility. Utilities will be determined through use of the Euro QoL Eq5D questionnaire. Data to be obtained from Canadian patients includes health care-related resource utilization and lost productivity. Secondary: Overall survival; toxicity; correlative markers; QoL. Secondary outcomes of economic analysis: cost effectiveness related to 'years gained' prior to second therapy and if possible 'years gained'. Lost productivity of the two randomized groups will also be compared. NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 13, 2009 Closing Date: December 24, 2009	Permanently Closed
CM1 (SWOG S0325)	A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. Read More Complexity Level: 2 Eligibility: Patients with chronic phase CML are eligible based on bone marrow aspirate, biopsy and peripheral blood counts obtained within 14 days before registration. Patients must have confirmed Philadelphia chromosome or variants of the (9-22) translation by cytogenetics or by FISH or be positive for BCR-ABL by RT-PCR. Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosomes. Patients must have a Zubroid performance status of 0 - 2. Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide. Patients must not have received prior chemotherapy for peripheral blood stem cell mobilization. Objectives: 1.1 To test whether increasing the dose of imatinib (STI571, Gleevec®) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase. 1.2 To estimate rates of cytogenetic and hematologic responses to each of the two imatinib dose levels. 1.3 To evaluate in a preliminary manner the prognostic effects of der(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib. 1.4 To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment. 1.5 To estimate the frequency and severity of toxicities of the two treatment regimens. NCT Registration ID (from clinicaltrials.gov): NCT00070499 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: September 30, 2005 Closing Date: February 28, 2009	Permanently Closed
HD1	Protocol For a Cooperative Clinical Trial Comparing MOPP Alone versus MOPP Followed by Radiation in Stage IIIB and IV Hodgkin's Disease Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 01, 1971 Closing Date: September 01, 1976	Permanently Closed
HD2	Comparison of Radiotherapy Alone With Radiotherapy Preceded by or Preceded and Followed by Three Courses of MOPP, With Standardized Treatment of First and Second Relapse and Incomplete Remission Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 14, 1977 Closing Date: June 11, 1979	Permanently Closed
HD3	Protocol For a Second Cooperative Clinical Trial for the Treatment of Patients With Stages IVB and IV Hodgkin's Disease Using Chemotherapy and Irradiation Therapy Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 01, 1977 Closing Date: May 01, 1980	Permanently Closed
HD4	A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 15, 1984 Closing Date: December 29, 1989	Permanently Closed
HD5 (8952)	Treatment of Advanced Hodgkin's Disease a Randomized Phase III Trial Comparing ABVD versus MOPP/ABV Hybrid Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: February 01, 1993 Closing Date: November 10, 1995	Permanently Closed
HD6	A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease Read More Eligibility: Patients with clinical stage I or IIA previously untreated Hodgkin's disease, excluding patients with very favourable or very unfavourable (bulky mediastinum) prognosis. Objectives: To compare 12 year survival between groups, to assess freedom from progression at 5 and 10 years, and to assess secondary endpoints: proportion of complete remission, proportion free from 2nd disease progression at 5 and 10 years, cause specific survival, toxicity, and quality of life. NCT Registration ID (from clinicaltrials.gov): NCT00002561 Participation: Limited to centres with current CPA # NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 25, 1994 Closing Date: April 05, 2002	Permanently Closed
HD7 (ECOG E2496)	A Randomized Phase III Trial of ABVD Versus Stanford V with or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease Read More Complexity Level: 2 Eligibility: Previously untreated patients with histologically proven Hodgkin's disease (HD). The diagnosis should be made by excisional biopsy whenever possible, but fine needle aspirate may suffice if 1) the morphology is unequivocal and 2) immunohistochemical studies are consistent with the diagnosis of HD. ECOG performance status must be 0 - 2. Objectives: To compare the failure-free survival in patients with locally extensive and advanced stage Hodgkin's disease treated with standard ABVD chemotherapy versus patients given Stanford V chemotherapy with or without radiotherapy. To assess overall survival and freedom from progression in these patients at 5 and 10 years. To assess secondary endpoints: pulmonary function, incidence of second cancers, reproductive function (baseline and 5 years) and deaths from causes other than Hodgkin's disease. NCT Registration ID (from clinicaltrials.gov): NCT00003389 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 07, 2000 Closing Date: June 15, 2006	Permanently Closed
HL1 (8691)	A Randomized Comparison of Deoxycoformycin versus Alpha Interferon in Previously Untreated Patients With Hairy Cell Leukemia Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: January 05, 1987 Closing Date: October 01, 1991	Permanently Closed
I100	NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 09, 1996 Closing Date: May 13, 1998	Permanently Closed
I108	A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 05, 1997 Closing Date: May 07, 1998	Permanently Closed
I127	A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma Read More Eligibility: Histologically or cytologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or with no prior therapy. Pathology must be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility BEFORE patient registration if questionable. Presence of clinically and/or radiologically documented disease. 0-2 prior chemotherapy regimens permitted. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Objectives: To assess the efficacy of flavopiridol, given as a 3 day bolus every 21 days. To assess the toxicity of flavopiridol when administered on this schedule in the patient group. NCT Registration ID (from clinicaltrials.gov): NCT00005074 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 24, 2000 Closing Date: October 10, 2001	Permanently Closed
I141	A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Read More Eligibility: Acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), not requiring urgent cytoreductive therapy. One prior chemotherapy regimen permitted. Objectives: To determine the maximum tolerated doses (MTD) and the recommended doses (RD) of two different schedules of BAY 43-9006 in patients with AML or MDS. To determine toxic effects, pharmacokinetics, gene expression, target effects and clinical response rates of BAY-43-9006 in this patient population. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 01, 2001 Closing Date: April 01, 2004	Permanently Closed
I145	A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma Read More Eligibility: Patients with confirmed diagnosis of multiple myeloma with a measurable serum or urine M-component at initial diagnosis. Patients must have relapsed following first or second line oral alkylating therapy or high dose chemotherapy and stem cell transplant. Patients are not eligible if they relapsed during prior treatment, have had > 2 prior chemotherapy regimens or relapsed within 3 months after last treatment. Objectives: To assess the efficacy of ZD6474 when given orally to patients with relapsed previously treated multiple myeloma. To determine the toxic effects, duration of response, time to progression, and pharmacokinetics profile and characteristics, as well as to examine bone marrow samples in patients with multiple myeloma given ZD6474. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 02, 2002 Closing Date: April 08, 2004	Permanently Closed
I150	A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma Read More Eligibility: Histologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or no prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. O-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior investigational therapy. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To determine 20S proteasome levels in whole blood and correlate suppression of this marker with toxicity and response to PS-341. NCT Registration ID (from clinicaltrials.gov): NCT00030875 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 04, 2002 Closing Date: July 28, 2004	Permanently Closed
I152 (IND.152)	A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia Read More Eligibility: Confirmed diagnosis of Waldenstrom's Macroglobulinemia. If newly diagnosed or untreated must have IgM > 20 g/L, if previously treated IgM must be > 5g/L at time of registration. Must be symptomatic. O-2 prior chemotherapy regimens, non-refractory to prior therapy; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray. NCT Registration ID (from clinicaltrials.gov): NCT00045695 Participation: Limited to invited centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 27, 2002 Closing Date: March 23, 2005	Permanently Closed
I16	NCIC CTG Phase II Study of Acivicin in Lymphoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 12, 1984 Closing Date: October 30, 1987	Permanently Closed
I172	Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma. Read More Eligibility: Histologically documented mantle cell lymphoma non-refractory to prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. 1-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior PS-341/bortezomib or other investigational therapy (excluding flavopiridol). Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Adequate organ function; no pre-existing edema, neuropathy or dyspnea >= gr 2 or ascites or pleural effusions. No serious cardiovascular disease and adequate cardiac function - LVEF >= 45%. Objectives: To determine the efficacy (response rate) of bortezomib given as a bolus intravenous injection twice weekly for 2 out of 3 weeks in combination with gemcitabine given as a 30 min. intravenous infusion once weekly for two consecutive weeks in patients with relapsed mantle cell lymphoma. To assess the toxicity of this combination as well as time to progression and response duration. NCT Registration ID (from clinicaltrials.gov): NCT00377052 Participation: Limited to selected centres. NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 14, 2006 Closing Date: September 19, 2008	Permanently Closed
I182	A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma Read More Eligibility: - Histologically documented diffuse large B-cell or mediastinal (thymic) large B-cell lymphoma, advanced or metastatic disease. - Patients must have received at least one, and up to two prior chemotherapy regimens, one of which must have been doxorubicin-based. - Patients may be relapsed post stem cell transplant as the preparative regimen and high dose chemotherapy will be considered as one regimen. Patients may have received one other non-chemotherapy regimen in the form of radiation. - No prior therapy with angiogenesis inhibitors or multi-targeted tyrosine kinase inhibitors - > 28 days since prior chemotherapy, hormonal therapy, radiation therapy or major surgery - Bidimensionally measurable disease; no known brain metastases - ECOG performance status: 0 or 1 - No serious medical conditions or cardiac disease (as specified in protocol); no uncontrolled hypertension Objectives: 1. To assess the efficacy (response rate) of sunitinib given orally daily in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 2. To assess the toxicity of sunitinib in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 3. To assess the effects of sunitinib on the peripheral blood biomarkers circulating endothelial cells (CECs) and their precursors (CEPs) in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. NCT Registration ID (from clinicaltrials.gov): NCT00392496 Participation: Limited to invited centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 08, 2006 Closing Date: March 24, 2009	Permanently Closed
I186	A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS Read More Complexity Level: 1 Eligibility: Patients age > 60 years and not suitable for intensive chemotherapy regimens with pathologically confirmed AML or high-risk MDS. o ECOG performance status 0, 1, or 2 o Prior Chemotherapy: None except hydroxyurea permitted provided discontinued > 48 hours prior to start of protocol therapy o Biochemistry: bilirubin and creatinine within normal limits, AST/ALT < 2 x UNL o No documented CNS involvement o No serious medical condition including: significant neurologic or psychiatric disorder, active uncontrolled infection Objectives: Phase I Portion: To determine the recommended dose of sorafenib and Ara-C given in combination in elderly patients with AML or high-risk MDS who are not suitable for intensive chemotherapy. To determine the safety, tolerability, toxicity profile and dose limiting toxicities of the combination sorafenib and Ara-C in this patient population. Phase II Portion: To estimate the efficacy (as measured by complete response rate) of the recommended dose of sorafenib given orally in combination with Ara-C in elderly patients with AML or high-risk MDS. To describe the toxic effects and overall response rate (complete plus partial) in this population. To evaluate potential correlates of response in translational research studies including FLT-3 ITD's and point mutations in blasts. NCT Registration ID (from clinicaltrials.gov): NCT00516828 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 24, 2007 Closing Date: December 10, 2009	Permanently Closed
I191	A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma Read More Complexity Level: 2 Eligibility: Patients must have a confirmed diagnosis of multiple myeloma and measurable disease, according to internationally accepted criteria for myeloma. Patients must have received prior treatment for multiple myeloma, and have relapsed or progressed on prior therapy. No more than three prior regimens; prior treatment must be completed at least 4 weeks prior to registration. ECOG performance status must be 0, 1 or 2; adequate hematologic and organ function. Objectives: To assess the efficacy of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks to patients with relapsed or refractory multiple myeloma; to determine the adverse effects of AT9283; to evaluate potential predictive and prognostic biomarkers (marrow, blood); and to evaluate disease-related symptoms including pain, fatigue and mucositis. NCT Registration ID (from clinicaltrials.gov): NCT01145989 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 15, 2010 Closing Date: July 26, 2012	Permanently Closed
I193	A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia. Read More Complexity Level: 2 Eligibility: Patients with documented chronic lymphocytic leukemia with at least one and up to 3 prior systemic treatment regimens. Patients must have either lymphocyte count >= 10 x 109/L or at least one measurable lymph node >= 2 cm x 2 cm to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2. Objectives: To assess the efficacy of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia. To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed/refractory CLL. To demonstrate the pharmacodynamic activity of AT7519M in patients with relapsed and/or refractory CLL by establishing its effects on relevant biological endpoints (markers of CDK inhibition, apoptotic markers and cell cycle suppressors) in circulating lymphocytes. To investigate the relationship between baseline cytogenetics and other molecular markers in response to AT7519M. NCT Registration ID (from clinicaltrials.gov): NCT01627054 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 21, 2012 Closing Date: November 22, 2013	Permanently Closed
I194	A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma Read More Complexity Level: 2 Eligibility: Patients with documented mantle cell lymphoma non-refractory to prior therapy. Patients must have received at least one and up to 3 prior systemic treatment regimens. Patients must have at least one site of bidimensional disease to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2. Objectives: Primary: To assess the efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed mantle cell lymphoma (MCL). Secondary: - To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed mantle cell lymphoma. - To explore potential proteomic and metabolic serum markers of clinical response to AT7519M in MCL by assessment of peripheral blood collected at baseline and on study. NCT Registration ID (from clinicaltrials.gov): NCT01652144 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 24, 2012 Closing Date: May 07, 2014	Permanently Closed
I20	NCIC CTG Phase II Study of Menogaril in Lymphoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 30, 1985 Closing Date: November 14, 1988	Permanently Closed
I22	NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 26, 1985 Closing Date: July 15, 1986	Permanently Closed
I3	NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 09, 1983 Closing Date: May 14, 1984	Permanently Closed
I62	NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 07, 1991 Closing Date: February 17, 1993	Permanently Closed
I78	NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 01, 1993 Closing Date: October 25, 1994	Permanently Closed
I84	NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 07, 1994 Closing Date: November 23, 1995	Permanently Closed
LY1	A Trial of BCG in Non-Hogkin's Lymphoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 07, 1976 Closing Date: May 01, 1981	Permanently Closed
LY10	A Phase II Study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) in Patients With Either Hodgkin's Disease or Aggressive Histology Non-Hodgkin's Lymphoma Which is Relapsed or Refractory Read More Eligibility: Patients with a diagnosis of either Hodgkin's disease or aggressive histology non-Hodgkin's lymphoma of B-cell origin, whose disease is refractory to or relapsed after one prior chemotherapy regimen. Objectives: To determine the efficacy (response rates and percent of complete remissions) following two cycles of treatment with GDP for patients with relapsed or refractory Hodgkin's disease and for patients with relapsed or refractory aggressive histology non-Hodgkin's lymphoma NCT Registration ID (from clinicaltrials.gov): NCT00014209 Participation: Not limited. NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 12, 2000 Closing Date: July 12, 2002	Permanently Closed
LY11 (S9704)	A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups Read More Complexity Level: 1 Eligibility: Patients must have biopsy proven intermediate or high grade non-Hodgkin's lymphoma (Working Formulation groups D through H and J) except lymphoblastic lymphoma (Working Formulation group I). Transformed lymphomas are not eligible. Mantle cell lymphomas are considered to be Working Formulation group E, but are ineligible for this study. Objectives: To compare in a cooperative group setting the overall survival and progression free survival of patients in the age adjusted High-Intermediate and High Risk Prognostic Groups of the International Classification with diffuse aggressive non-Hodgkin¿s lymphomas who are treated on a randomized trial that compares standard conventional chemotherapy to an abbreviated course of induction chemotherapy followed by early transplantation. To compare the toxicity of these treatment strategies. NCT Registration ID (from clinicaltrials.gov): NCT00004031 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: November 28, 2001 Closing Date: December 15, 2007	Permanently Closed
LY13	A Multi-centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone and Rituximab (BCVP-R) for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment Read More Eligibility: Patients with histologically confirmed, advanced stage (III or IV) follicular lymphoma requiring systemic first-line treatment will be eligible. Objectives: Primary: To assess the efficacy (complete response rate, CR/CRu) of BCVP-R as treatment for patients with advanced stage follicular non-Hodgkin's lymphoma requiring systemic first-line treatment; to assess the incidence of severe neurotoxicity (defined as grade 3 or 4 neuropathy/ neuropathic pain during the first four cycles) of the BCVP-R regimen in this group of patients. Secondary: To assess overall response rate in patients treated with the combination of BCVP-R, and to determine the response duration; to determine progression-free and overall survival in this patient group; to evaluate the tolerability and characterize the toxicity profile of the BCVP-R regimen in this patient population; to assess quality of life with particular focus on neurotoxicity-related changes in this patient population treated with BCVP-R. Correlative Studies. Apoptocic molecule expression, the role of the microenvironment, and Fc receptor polymorphisms. NCT Registration ID (from clinicaltrials.gov): NCT00428142 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 14, 2006 Closing Date: March 06, 2009	Permanently Closed
LY2	Treatment of Poor Prognosis Lymphomas With Bone Marrow Involvement, Intensive BACOP Chemotherapy Under Cover of Septra Prophylaxis Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 01, 1980 Closing Date: December 01, 1980	Permanently Closed
LY3	A Comparison of Standard BACOP With Escalated BACOP in Patients With Poor Prognosis Non-Hodgkin's Lymphoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 10, 1982 Closing Date: April 19, 1989	Permanently Closed
LY4	Phase I/II Study of Chemotherapy Intensification for Patients With Poor Prognosis Advanced Stage Aggressive histology Lymphoma: VACOP-B Plus Etoposide and Cyclophosphamide With RhuGM-CSF (VACOP-B/EC/CSF) Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 01, 1992 Closing Date: October 25, 1994	Permanently Closed
LY7 (EORTC 20981)	Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma: A Phase III Randomized Clinical Trial Read More Complexity Level: 2 Eligibility: Patients with stage III or IV follicular non-Hodgkin's lymphoma (at initial diagnosis) who have relapsed after a maximum of two non-anthracycline containing systemic chemotherapy regimens. Patients must have had a complete or partial response to at least one of the previous regimens. Lymphoma must be CD20 positive. Objectives: To establish the effect of addition of rituximab to CHOP chemotherapy on the response rate and quality of remission in relapsed low grade non-Hodgkin's lymphoma. To establish the effect of maintenance treatment with rituximab on progression free survival in relapsed low grade non-Hodgkin's lymphoma in remission after CHOP ± rituximab. NCT Registration ID (from clinicaltrials.gov): NCT00004179 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: May 15, 2000 Closing Date: February 06, 2004	Permanently Closed
LY9 (M39045)	Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8) Read More Complexity Level: 2 Eligibility: Patients aged 18 to 60 years with untreated CD20-positive diffuse large B-cell non-Hodgkin's lymphoma. Patients must have stage II to IV or stage I with bulky disease according to Ann Arbor staging. Objectives: To determine the safety and efficacy of rituximab antibody in patients with diffuse large B-cell non-Hodgkin's lymphoma in combination with a standard CHOP-like chemotherapy regimen. The primary endpoint of this trial is the time to treatment failure. NCT Registration ID (from clinicaltrials.gov): NCT00064116 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: May 08, 2001 Closing Date: October 17, 2003	Permanently Closed
MY1	A Comparison of the Administration of Melphalan, Cyclophosphamide and BCNU in Sequential Alternating and Concurrent Schedules in the Treatment of Plasma Cell Myeloma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 01, 1973 Closing Date: March 01, 1977	Permanently Closed
MY10 (MY10)	A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma Read More Complexity Level: 2 Eligibility: Patients with histologically confirmed myeloma who had had an autologous stem cell transplant within one year of the beginning of initial treatment for their disease. Patients must be randomized within 60-100 days post transplant and have no other medical condition precluding long term use of prednisone or thalidomide. Objectives: Primary: to determine if maintenance treatment post transplant with thalidomide and prednisone (TP) prolongs overall survival compared with observation alone. Secondary: to determine if TP prolongs progression-free survival compared with observation alone; to compare quality of life, toxic effects, and the incidence of venous thromboembolism between the two patient groups. Correlative Studies Endpoints: to correlate FISH-identified chromosome translocations at relapse with clinical outcome in the two patient groups; to determine if there is evidence of increased thrombin generation in patients receiving TP as compared with those not. NCT Registration ID (from clinicaltrials.gov): NCT00049673 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 16, 2002 Closing Date: January 30, 2009	Permanently Closed
MY11	A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma Read More Eligibility: Previously untreated patients with histologically confirmed myeloma who are not considered candidates for future peripheral blood stem cell autotransplantation by virtue of advanced age, co-morbid illness or patient preference. Objectives: Primary: 1) To evaluate the tolerability of combination therapy with lenalidomide and melphalan in patients with previously untreated multiple myeloma not destined for future autologous stem cell transplant. Two starting doses of lenalidomide (15mg or 10mg days 1-21 each 28 day cycle) will be investigated. 2) To determine an estimate of the efficacy of the combination of melphalan and lenalidomide. The primary measure of efficacy will be the percentage of patients who, after completing six cycles of therapy, achieve a complete remission using European Group for Blood and Marrow Transplantation/International Bone marrow transplant registry criteria for remission assessment. NCT Registration ID (from clinicaltrials.gov): NCT00305812 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 13, 2005 Closing Date: March 27, 2008	Permanently Closed
MY2	Continuing versus Stopping Therapy in Patients Stabilized on Melphalan and Prednisone Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 23, 1977 Closing Date: December 14, 1984	Permanently Closed
MY3	Pilot Study of Weekly Cyclophosphamide and Prednisone Therapy for Patients Unresponsive to Melphalan and Prednisone Induction Therapy Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 01, 1982 Closing Date: September 01, 1984	Permanently Closed
MY4	Etidronate Disodium (EHDP) Versus Placebo in the Treatment of Multiple Myeloma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 19, 1983 Closing Date: February 28, 1987	Permanently Closed
MY5	Modified VAD (m-VAD-VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE) in Primary Refractory and Relapsed Plasma Cell Myeloma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 28, 1986 Closing Date: October 17, 1989	Permanently Closed
MY6	Clinical Trial of Interferon versus no Additional Treatment in Multiple Myeloma Patients Who Have Responded to Melphalan and Prednisone Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 04, 1987 Closing Date: June 26, 1992	Permanently Closed
MY7	A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients Read More Eligibility: Patient with newly diagnosed, histologically proven, untreated, symptomatic Stage I or Stage II or III myeloma, with either a measurable serum M-protein or Bence Jones M-protein of >1.0g/24h and an ECOG performance status of <4. Objectives: To Compare overall survival between patients receiving M+P versus M+D as induction therapy and patients maintained by dexamethasone versus observation. To compare time progression, response rates, incidences of toxicities and quality of life with the same groups of patients. NCT Registration ID (from clinicaltrials.gov): NCT00002678 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 02, 1995 Closing Date: July 16, 2003	Permanently Closed
MY8 (E1A95)	A Phase III Study Of PSC-833 In Combination With Vincristine, Doxorubicin And Dexamethasone (PSC-833/VAD) vs VAD Alone In Patients With Relapsing Or Refractory Mutilple Myeloma Read More NCT Registration ID (from clinicaltrials.gov): NCT00002878 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: July 28, 1997 Closing Date: May 10, 2000	Permanently Closed
MY9	Randomized Phase II Dose Finding Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma Read More NCT Registration ID (from clinicaltrials.gov): NCT00006890 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 12, 2000 Closing Date: September 07, 2001	Permanently Closed

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