Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Fludarabine; Lenalidomide
Intervention description: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles; 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles; 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
Intervention MeSH terms: Rituximab; Fludarabine; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia

Summary:

      This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received
      any treatment for their disease.

      Current therapy for this disease includes the use of combination chemotherapy regimens
      containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In
      this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of
      Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this
      research because we are attempting to improve the response, or outcome, of Fludarabine and
      Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune
      system and it may also interfere with the development of tiny blood vessels that help support
      tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells.
      Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific
      types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients
      with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of
      blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being
      tested in a variety of cancer conditions. In this case it is considered experimental.

      This research is being done because we are attempting to find a better treatment for chronic
      lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of
      Fludarabine and Rituximab.

      The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen
      of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and
      Rituximab alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign informed consent form

          -  No prior therapy for CLL

          -  Able to adhere to study visit schedule and other protocol requirements

          -  CLL with any Rai Stage requiring therapy

          -  ECOG performance status </= 2

          -  Absolute neutrophil count >/= 1.0

          -  Platelet count >/= 75

          -  Serum creatinine </= 1.5

          -  Total bilirubin </= 1.5

          -  AST and ALT </= 2 x ULN

          -  Females of childbearing potential must have negative pregnancy test

          -  Disease free of prior malignancies for >/= 5 years

          -  Able to take aspirin daily as prophylactic anticoagulation

        Exclusion Criteria:

          -  Any serious medical condition, lab abnormality, or psychiatric illness that would
             prevent the subject from signing the informed consent form

          -  Pregnant or lactating females

          -  Any condition, including the presence of lab abnormalities, which places the subject
             at unacceptable risk if he/she were to participate in the study

          -  Use of any other experimental drug or therapy within 28 days of baseline

          -  Concurrent use of other anti-cancer agents or treatments

          -  Known positive for HIV or infectious active hepatitis, type A, B

          -  Known hypersensitivity to nucleoside analogue or rituximab

          -  Previous treatment for CLL prior to enrolling in study

          -  Known hypersensitivity to thalidomide

          -  The development of erythema nodosum if characterized by desquamating rash while taking
             thalidomide or similar drugs

          -  Any prior use of lenalidomide

          -  Active hemolysis