drugset / Trial / NCT02071225

A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia

NCT02071225 ↗

Phase 2 Completed 72 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL). Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6 months, and participant follow-up will last 2 years.

Timeline

Start
2014-04-09
Primary completion
2018-11-19
Completion
2018-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 70 mg/m2 Intravenous
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous