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Brief Title: Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia
Official Title: A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)
Study ID: NCT01649791
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Roswell Park Cancer Institute, Buffalo, New York, United States
Name: Myron Czuczman
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR