Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: rituximab; lenalidomide
Intervention description: IV; Oral
Intervention MeSH terms: Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: 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 chronic lymphocytic
      leukemia.
    

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