Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Official Title

A Phase II, Multi-center, Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Different Lenalidomide (Revlimid) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

Summary:

The purpose of this study is to determine the safety and effectiveness of different dose regimen of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.

Trial Description

Primary Outcome:

• Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide]

• Response rate [per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines for diagnosis and treatment of CLL (Hallek, 2008)]
• Duration of response, Time to response, Time to progression, Event-free survival, Progression-free survival, Overall survival

View this trial on ClinicalTrials.gov