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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression free survival
Efficacy: All measurements will be compared with baseline values: Lymph nodes, spleen and liver measurements by physical examination Complete blood count (CBC) Peripheral blood smear Flow cytometry of peripheral blood for MRD assessment Bone marrow aspirate/biopsy for standard histopathology and flow cytometry for MRD assessment Computed tomography (CT) scans if clinically indicated ECOG Performance Status Assessment of constitutional symptoms
up to 5 years
No
Anna Fink, MD
Study Chair
German CLL Study Group
Germany: Federal Institute for Drugs and Medical Devices
CLLM1 Protocol of the GCLLSG
NCT01556776
July 2012
May 2017
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