Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)
This clinical trial studies lenalidomide as chemoprevention in treating patients with high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lenalidomide may slow disease progression in patients with early stage B-cell chronic lymphocytic leukemia
PRIMARY OBJECTIVES:
I. To determine time to progression in patients with high risk CLL.
SECONDARY OBJECTIVES:
I. Overall response rate including (complete remission [CR]+partial remission [PR]) of
lenalidomide.
II. To determine the incidence of immune mediated flare reaction. III. To characterize the
toxicity profile of single agent lenalidomide in previously untreated B-CLL.
IV. To correlate expression of B-CLL co-stimulatory ligands and clinical efficacy of
lenalidomide in this patient population.
V. To conduct correlative studies.
OUTLINE: Patients receive lenalidomide orally (PO) once daily for 4 weeks. Treatment repeats
every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3
months for 5 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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