Lenalidomide for the Treatment of CLL Patients With High-Risk Disease
I. To determine the time to progression in patients with high-risk chronic lymphocytic
leukemia (CLL) treated with lenalidomide.
I. To determine the clinical response (complete and partial response) in treatment-naïve
patients with high-risk CLL treated with single-agent lenalidomide.
II. To determine the incidence of immune-mediated flare reaction. III. To determine the
toxicity profile of single-agent lenalidomide in previously untreated patients with
IV. To conduct correlative studies in bone marrow, peripheral blood, and/or lymph nodes of
patients treated with lenalidomide.
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days
for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who
achieve complete response (by morphological criteria but have persistent minimal residual
disease by molecular criteria) or partial response may continue treatment beyond 8 courses.
Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at
baseline and periodically during study for correlative studies.
After completion of study therapy, patients are followed up every 3 months for a maximum of
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|