• Number of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) at 6 months [ Designated as safety issue: No ]
  

• Number of patients achieving a CR, PR, or SD [ Designated as safety issue: No ]
  
• Number, type, and severity of adverse events [ Designated as safety issue: Yes ]
  
• Time to progression [ Designated as safety issue: No ]
  

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.

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