A Study of Lenalidomide Maintenance for High-risk Patients With CLL Following First-line Therapy
Status:
Completed
Trial end date:
2021-01-14
Target enrollment:
Participant gender:
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).