A Study of Lenalidomide Maintenance for High-risk Patients With CLL Following First-line Therapy

Summary

CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that compares the efficacy and safety of oral lenalidomide maintenance therapy to that of placebo maintenance therapy in high-risk subjects with Chronic Lymphocytic Leukemia (CLL) who have achieved at least a partial response (PR) and either: * MRD levels of ≥ 10-2 or * MRD levels of ≥ 10-4 - \< 10-2 combined with at least one of the following factors: * an unmutated IGHV-status * 17p-deletion or * TP53 mutation after first line therapy with FCR, FR, BR or FC (in case of of contraindications to receive Rituximab).

Timeline

Start

2012-07-20

Primary completion

2016-03

Completion

2021-01-14

Publications

• Results Fink AM, Bahlo J, Robrecht S, Al-Sawaf O, Aldaoud A, Hebart H, Jentsch-Ullrich K, Dorfel S, Fischer K, Wendtner CM, Nosslinger T, Ghia P, Bosch F, Kater AP, Dohner H, Kneba M, Kreuzer KA, Tausch E, Stilgenbauer S, Ritgen M, Bottcher S, Eichhorst B, Hallek M. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study. Lancet Haematol. 2017 Oct;4(10):e475-e486. doi: 10.1016/S2352-3026(17)30171-0. Epub 2017 Sep 12.
• Results Furstenau M, Fink AM, Schilhabel A, Weiss J, Robrecht S, Eckert R, de la Serna J, Crespo M, Coscia M, Vitale C, Bottcher S, Weppner G, Ritgen M, Stilgenbauer S, Tausch E, Fischer K, Hallek M, Eichhorst B, Bruggemann M, Herling CD. B-cell acute lymphoblastic leukemia in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2021 Apr 22;137(16):2267-2271. doi: 10.1182/blood.2020008609. No abstract available.

Drugs

Indications