NCT01556776

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

CLLM1-Protocol of the German CLL-Study Group (GCLLSG) A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for High-risk Patients With Chronic Lymphocytic Leukemia Following First-line Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

CLLM1 is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of lenalidomide administered as maintenance treatment to subjects with CLL who have responded to first-line therapy (induction) achieving a response of at least PR and are at high risk of early progression. This study will compare the efficacy of lenalidomide maintenance treatment versus placebo at prolonging progression free survival (PFS); and as secondary endpoints assess overall survival, the safety of lenalidomide treatment and evaluate Minimal residual disease (MRD) kinetics in peripheral blood whilst subjects are on maintenance. Although maintenance therapy has been established in recent years for the treatment of a subset of subjects with Non-Hodgkin's Lymphoma (NHL), it is a novel concept in the management of CLL. It is not regularly used and only a limited number of small studies have been conducted evaluating consolidation/maintenance therapy for limited periods of time with alemtuzumab or rituximab. Based on the limited amount of available data, it appears that maintenance therapy may improve the quality of remission in CLL subjects and prolong progression-free survival (PFS). A large phase 3 trial investigating lenalidomide as maintenance following response to second line therapy is ongoing. However, a large well-controlled study has not been conducted to investigate the beneficial effect of maintenance therapy following front line therapy; specifically in subjects with aggressive disease. This phase 3 study will evaluate whether lenalidomide maintenance therapy will prolong PFS in CLL subjects with a high risk of early progression following first line treatment.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	lenalidomide	placebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide
DRUG	Placebo	placebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide

Timeline

• Start date: 2012-07-20
• Primary completion: 2016-03-01
• Completion: 2021-01-14
• First posted: 2012-03-16
• Last updated: 2022-01-05

Locations

2 sites across 1 country: Germany