drugset / Trial / NCT02529852

A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma

NCT02529852

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-11-04
Primary completion
2022-10-31
Completion
2022-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 15 mg Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications