A Trial of Obinutuzumab,GDC-0199 Plus Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma Patients

Summary

Participation Requirements

Description

The study will be conducted into 3 steps for respecting the optimal safety of the OASIS trial: Step A : The primary objective of step A is to evaluate the safety of the combination of GA101 + Ibrutinib at fixed doses (560 mg per day of Ibrutinib + 1000 mg of GA101), in patients with relapsed or refr...

The study will be conducted into 3 steps for respecting the optimal safety of the OASIS trial: Step A : The primary objective of step A is to evaluate the safety of the combination of GA101 + Ibrutinib at fixed doses (560 mg per day of Ibrutinib + 1000 mg of GA101), in patients with relapsed or refractory Mantle Cell Lymphoma (MCL). Secondary objectives: To describe the efficacy of the combination of GA101 and Ibrutinib in terms of clinical benefits response (overall response rate, complete response rate, partial response rate Cheson 99 and 07 criteria and Working Group Revised Response Criteria for Malignant Lymphomas 14), overall survival, progression free survival. To describe the safety and tolerability of the combination of GA101 and Ibrutinib To establish a bio-bank to explore biomarkers and mechanisms of action including resistance Step B : Step B started because no unacceptable toxicity occurred in patients included in the step A. The primary objective of this step is to determine the maximal tolerated dose (MTD) of the GDC-0199 in addition to the GA101 and Ibrutinib in relapsed refractory MCL patients by using a Continual Reassessment Method (CRM), used up to the 12th enrolled patients. No DLT occured for the first 12 patients. Based on the most recent publications, the dose of 400mg/d will be used from the 13th to the 24th patients (no CRM used). Secondary objectives: To describe the efficacy of the combination GA101, Ibrutinib and GDC-0199 in terms of clinical benefits response (overall response rate, complete response rate, partial response rate Cheson 99 and 07 criteria and Working Group Revised Response Criteria for Malignant Lymphomas 14), overall survival, progression-free survival. To describe the safety and tolerability of the novel combination of GDC-0199, GA101 and Ibrutinib To establish a bio-bank to explore biomarkers and mechanism of action including resistance Step C : This step has started because no unacceptable toxicity was observed during the second step. The primary objective of this step is to confirm the safety of the combination of GA101 + Ibrutinib + GDC-199 at fixed doses (560 mg per day of Ibrutinib + 1000 mg of GA101, 400mg/d of GDC-199 ), in patients with untreated Mantle Cell Lymphoma (MCL), at end of Cycle 2. Secondary objectives : To describe the efficacy of the combination GA101, Ibrutinib and GDC-0199 in terms of clinical benefits response (overall response rate, complete response rate, partial response rate cheson 99 and 07 criteria and Working Group Revised Response Criteria for Malignant Lymphomas 14), overall survival, progression-free survival. To describe the safety and tolerability of the novel combination of GDC-0199, GA101 and Ibrutinib To establish a bio-bank to explore biomarkers and mechanism of action including resistance

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