A Phase I/II Study of Lenalidomide and Obinutuzumab with CHOP for Diffuse Large B Cell Lymphoma
Jason R. Westin
There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) that can be given to patients with diffuse large B cell lymphoma. The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts.
Treatment Location: N/A
Primary 1) The primary objective of the phase Ib portion of the trial will be to determine the maximum tolerated dose of lenalidomide + obinutuzumab with CHOP. 2) The primary objectives of the Phase II portion of the trial will be to determine the efficacy (complete and overall response rate). Secondary 1) The secondary objectives of the Phase Ib portion will include the efficacy (overall and complete response rate) and tolerability of lenalidomide + obinutuzumab with CHOP. 2) The secondary objectives of the Phase II portion will include determination of the survival outcomes (progression free and overall survival), and safety.
IRB Review and Approval Date: 11/04/2015
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Phase I/Phase II
Jason R. Westin
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