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

Phase 3 Completed 450 enrolled Celgene Corporation

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2009-10-13
Primary completion: 2014-03-31
Completion: 2018-05-09

Outcome

Missed primary endpoint

registry analysis (superiority test); Lenalidomide vs Chlorambucil; p = 0.323; Hazard Ratio (HR) 1.21 (90% CI 0.88 to 1.66); stratified log rank NCT00910910 ↗

registry analysis (superiority test); Lenalidomide vs Chlorambucil; p = 0.967; Cox Proportional Hazard 0.99 (90% CI 0.76 to 1.29); Log Rank NCT00910910 ↗

Publications

Results Chanan-Khan A, Egyed M, Robak T, Martinelli de Oliveira FA, Echeveste MA, Dolan S, Desjardins P, Blonski JZ, Mei J, Golany N, Zhang J, Gribben JG. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240-1243. doi: 10.1038/leu.2017.47. Epub 2017 Jan 31. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Chlorambucil	Other / unclassified	0.8 mg/kg	Oral
Subject	Lenalidomide	Other / unclassified	7.5 mg	—
Subject	Lenalidomide	Other / unclassified	15 mg	—