Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)

Official Title

A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study Of The Efficacy & Safety Of Lenalidomide (Revlimid®) Vs. Chlorambucil As First-Line Therapy For Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia

Summary:

The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS)

Secondary Outcome:

• Safety [type, frequency, and severity of adverse events (AEs)]
• Response, including evaluation of minimal residual disease (MRD) by flow cytometry (Hallek, 2008)
• Duration of response
• Time to response
• Overall survival (OS)
• Health-Related Quality of Life (HRQL) by Functional Assessment of Cancer Therapy -Leukemia (FACT-Leu) and EQ-5D

CC-5013-CLL-008 is a Phase 3, multi-center, randomized, open-label, parallel-group study that will compare the efficacy and safety of oral lenalidomide to that of oral chlorambucil in elderly patients with previously untreated B-cell CLL. Eligible patients must not have received any treatment for their B-cell CLL, must be symptomatic, and must be ≥ 65 years of age.