A Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomide in Patients With Chronic Lymphocytic Leukemia

Phase 1/2 Completed 22 enrolled German CLL Study Group Celgene Corporation · collab Mundipharma Research GmbH & Co KG · collab Roche Pharma AG · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, multicenter, open label, non-randomized, phase I/II-study to define safety and efficacy of BRL combination in relapsed/refractory patients and to recommend a safe and efficacious dose for future phase II/III study. Hypothesis: The simultaneous administration of BRL in relapsed CLL is feasible, safe and efficient.

Timeline

Start: 2011-02
Primary completion: 2013-10
Completion: 2015-06

Publications

Results Maurer C, Pflug N, Bahlo J, Kluth S, Rhein C, Cramer P, Gross-Ophoff C, Langerbeins P, Fink AM, Eichhorst B, Kreuzer KA, Fischer N, Tausch E, Stilgenbauer S, Bottcher S, Dohner H, Kneba M, Dreyling M, Binder M, Hallek M, Wendtner CM, Bergmann M, Fischer K; German CLL Study Group. Bendamustine and rituximab in combination with lenalidomide in patients with chronic lymphocytic leukemia. Eur J Haematol. 2016 Sep;97(3):253-60. doi: 10.1111/ejh.12714. Epub 2016 Feb 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	50 mg/m2	Intravenous
Subject	Lenalidomide	Other / unclassified	2.5 mg	Oral
Subject	Lenalidomide	Other / unclassified	5 mg	Oral
Subject	Lenalidomide	Other / unclassified	10 mg	Oral
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Rituximab	Monoclonal antibody	500 mg/m2	Intravenous

A Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomide in Patients With Chronic Lymphocytic Leukemia

Summary

Timeline

Publications

Drugs

Indications