Wednesday, December 11, 2019 CCTG LY18, A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma, has been centrally activated. The purpose of this study is to find the highest dose of a new drug, in combination with standard drugs, which can be tolerated without causing very severe side effects. The study treatment is new agents in combination with R-GDP or an equivalent regimen. 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. Visit the CCTG LY18 trial page for more information.
