Chronic Lymphocytic Leukemia Clinical Trial
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Summary
RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory leukemia-cll/" >chronic lymphocytic leukemia.
Full Description
OBJECTIVES:
Primary
Determine the best cytostatic response rate (including complete response, partial response, or stable disease) in patients with relapsed or refractory chronic lymphocytic leukemia treated with lenalidomide (CC-5013).
Secondary
Determine the cytostatic response rate in patients who progress on CC-5013 and are then treated with CC-5013 and rituximab.
Determine the safety of these regimens in these patients.
Determine time to progression in patients treated with these regimens.
OUTLINE: This is an open-label, non-randomized, pilot study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.
Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry
Relapsed or refractory disease
Measurable disease, defined by 1 of the following criteria:
Absolute lymphocyte count ≥ 5,000/mm^3
Measurable lymphadenopathy or organomegaly
Received ≥ 1 prior therapy for CLL
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
See Disease Characteristics
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 30,000/mm^3
Hepatic
Bilirubin ≤ 1.5 mg/dL
AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
Renal
Creatinine ≤ 1.5 mg/dL
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
No known hypersensitivity to thalidomide
No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration
No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins
No serious medical condition or laboratory abnormality that would preclude study participation
No psychiatric illness that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior lenalidomide (CC-5013)
No concurrent thalidomide
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
No concurrent radiotherapy
Surgery
Not specified
Other
At least 4 weeks since prior therapy for CLL
At least 28 days since prior experimental drug or therapy
No other concurrent anticancer therapies
No other concurrent investigational agents
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There is 1 Location for this study
Buffalo New York, 14263, United States
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