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ALC9 (MM2YA-EA01)

Eradicating Minimal Residual Disease in patients with AML prior to Stem Cell Transplant (ERASE): A MyeloMATCH Treatment Trial


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


Complexity Level: 2

NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
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.


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.


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
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

Patients with untreated high-risk acute myeloid leukemia (AML) will receive either (1) cytarabine + daunorubicin, (2) cytarabine + daunorubicin + venetoclax, (3) azacitidine + venetoclax, (4) (cytarabine and daunorubicin) liposome, or (5) (cytarabine and daunorubicin) liposome + venetoclax to compare the rates of complete remission between treatments.


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: Open to Accrual
Activation Date: September 25, 2024

Chair: (Canada) Dr. Guillaume Richard-Carpentier, Princess Margaret Cancer Centre, (416) 946-4501 Ext. 5375


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


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.


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: Yes
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


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?


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.


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
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.


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.


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


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


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
LY17

A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma


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: On Hold
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


On Hold
AL5 (DFCI 06-254)

Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial


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.


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).


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


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


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.


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


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)


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