At a glance
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A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Lenalidomide, Obinutuzumab, and 4 other interventions for Lymphoma. Completed, enrolled 59 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Phase I Starting Dose Level: 15 mg by mouth on Days 1 - 14 of each 21 day cycle. Phase II Starting Dose Level: Maximum tolerated dose from Phase I.
Phase I and II: 1000 mg by vein on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 - 6.
Phase I and II: 750 mg/m2 vein over about 1 hour on Day 1 of all cycles.
Phase I and II: 50 mg/m2 by vein over about 15 minutes each on Day 1 of all cycles.
Phase I and II: 1.4 mg/m2 by vein on Day 1 of all cycles.
Phase I and II: 100 mg by mouth daily on Days 1 - 5 of each 21 day cycle.