Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 chronic lymphocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: Celgene
• Treatments: Lenalidomide; Rituximab; Thalidomide

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