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Revlimid and Rituximab in First-Line CLL
NCT00628238Phase 2
Key facts
- Status
- Unknown
- Start
- Feb 2008
- Primary completion
- Feb 2011
- Countries
- 1
- Sponsor
- Chronic Lymphocytic Leukemia Research Consortium
- Modality
- Small Molecules
- Drugs
- lenalidomide
- Conditions
- chronic lymphocytic leukemia (CLL)
01
Overview
Phase 2, open-label trial of lenalidomide in chronic lymphocytic leukemia (CLL) (2 arms), sponsored by Chronic Lymphocytic Leukemia Research Consortium. Primary endpoints: Clinical Response Rate and NCI-CLL Working Group Response Rate. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Subjects < 65 years
Lenalidomide + Rituximab
Subjects >= 65 years
Lenalidomide + Rituximab
03
Who it enrols
Patients with previously untreated CLL, age >= 18, ECOG <= 2, and adequate organ function. Excludes patients with prior CLL treatment, active infection, HIV, Hep B/C, or history of thromboembolic events.
04
Endpoints
Primary
Clinical Response Rate
NCI-CLL Working Group Response Rate
Secondary
Adverse Events
Time To Progression
Response Duration
Improvement in Hematologic Parameters
Significance of Tumor Flare Reaction
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