LY17

LY17 Details
Status: Open
Activation Date: 2015MAY05
Phase: II

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

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.

Objective: To determine the overall response rate (complete and partial response) to novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma.

Participation: Open to member centres

Lay Description: 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

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Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
HEMATOLOGIC	LY17	Open Trial	33	65	71

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
HEMATOLOGIC	LY17	Open Trial	1	1

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
HEMATOLOGIC	LY17	Open Trial	88	0	0	0	91	87	0	0