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

NCT01556776 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2022-01-05

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Anna Fink, MD · German CLL Study Group

  • Barbara Eichhorst, MD · German CLL Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-20
Primary Completion
2016-03-31
Completion
2021-01-14

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01556776 on ClinicalTrials.gov