Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukaemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide
Intervention description: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle.Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lenalidomide; immunomodulatory drug (IMiD®); Thalidomide analogues

Summary:

      This study will assess the

        -  efficacy (response rate) of oral lenalidomide in the treatment of patients with
           symptomatic, previously untreated, chronic lymphocytic leukemia (CLL),

        -  toxicity of lenalidomide in patients with CLL as well as time to progression, stable
           disease duration and, if responses are observed, response duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form.

          -  Age ≥18 years at the time of signing the informed consent form.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  A confirmed diagnosis of B-cell CLL by NCI Working Group criteria

          -  No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias
             (anemia or thrombocytopenia) is NOT considered a prior systemic therapy.

          -  Radiation: Patients may have received prior radiation therapy restricted to ≤ 25% of
             functioning bone marrow. Patients must be ≥ 4 weeks since last treatment with
             radiation therapy.

          -  Surgery: previous surgery is permissible. Patient must be ≥ 4 weeks since any major
             surgery.

          -  Patients must have symptomatic disease requiring therapy. One or more of the following
             must be present to be eligible:

               -  Symptomatic lymphadenopathy

               -  Hepatomegaly and/or splenomegaly

               -  Anemia (Hb <110 g/L)

               -  Thrombocytopenia (platelets <100)

               -  Fatigue, weight loss, night sweats, fever (without infection) or other
                  constitutional symptoms felt to require treatment as per treating physician
                  discretion

               -  Persistent rise in lymphocyte count with doubling time of < 12 months

          -  ECOG performance status of ≤ 2 at study entry.

          -  Laboratory Requirements: (must be done within 7 days prior to first study drug dose)

        Hematology: Absolute granulocytes (AGC) ≥ 1.0 x 109/L Platelets ≥ 50 x 109/L Chemistry:
        Serum creatinine ≤ 1.5 x UNL Bilirubin ≤ 1.5 x UNL AST (or ALT if AST ≤ 2.5 x UNL not
        available)

          -  Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and
             repeated within 24 hours of starting study drug and must either commit to continued
             abstinence from heterosexual sexual intercourse or begin TWO acceptable methods of
             birth control, one highly effective methods and one additional effective method AT THE
             SAME TIME, at least 4 weeks before she starts taking lenalidomide. In addition,
             sexually active WCBP must agree to ongoing pregnancy testing. Men must agree not to
             father a child and agrees to use a condom if his partner is of child bearing
             potential.

          -  Disease free of prior malignancies for ≥ 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast

        Exclusion Criteria:

          -  Patients who fulfill any of the following criteria are not eligible for admission to
             the study:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          -  Pregnant or lactating females. (Lactating females must agree not to breast feed while
             taking lenalidomide).

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          -  Use of any other experimental drug or therapy within 28 days of baseline.

          -  Patients previously or currently receiving treatment with other anti-cancer therapy
             for CLL

          -  Lymphoproliferative disease other than CLL (includes patients with prolymphocytic
             leukemia, mantle cell lymphoma, and those who have transformed to a more aggressive
             lymphoma, or Richter's syndrome).

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Any prior use of lenalidomide.

          -  Concurrent use of other anti-cancer agents or treatments.

          -  Known positive for HIV or infectious hepatitis, type A, B or C.