Revlimid® as Consolidation Treatment Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide
Intervention description: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic; Lymphocytic; Leukemia

Summary:

      The purpose of this study is to determine whether on course (6 cycles) of consolidation
      therapy with Revlimid can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL) in
      the bone marrow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic lymphocytic leukemia:

          -  Previously treated patients of any age with a diagnosis of CLL with documented
             residual disease following therapy, but not meeting an indication for treatment based
             on current guidelines

          -  At least 2 months following previous CLL directed therapy

          -  ECOG performance status of less than or equal to 2 at study entry

          -  Laboratory test results within these ranges:

               -  Platelet count greater than or equal to 50 x 109/L

               -  CrCl >.60 ml/min

               -  Total bilirubin less than or equal to 1.5 mg/dL

               -  AST (SGOT) and ALT (SGPT) less than or equal to 2 x ULN

          -  Females of childbearing must adhere to strict guidelines and have negative pregnancy
             test prior to enrollment

          -  Understand and voluntarily sign an informed consent form.

          -  Age greater than or equal to 18 years at the time of signing the informed consent
             form.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  Disease free of prior malignancies for greater than or equal to 2 years with exception
             of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in
             situ" of the cervix or breast.

          -  All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

          -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
             intolerant to aspirin may use warfarin or low molecular weight heparin).

        Exclusion Criteria:

          -  Known Hepatitis B Ag positive, Hepatitis C positive patients.

          -  Known HIV positive patients.

          -  Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune
             thrombocytopenia (ITP)

          -  Patients with active fungal, bacterial, and/or viral infection

          -  Patients with known hypersensitivity to Revlimid or thalidomide

          -  Concurrent use of other anti-cancer agents or treatments

          -  Patients with history of deep venous thrombus or pulmonary embolism

          -  Patients who are at increased risk of thrombosis during treatment with Revlimid
             including those taking concurrent erythropoietin, darbepoetin or high-dose
             corticosteroids

          -  Inability to provide informed consent.

          -  Concurrent malignancy (excluding basal and squamous cell skin cancers).

          -  Pregnant or breast-feeding females. (Lactating females must agree not to breast feed
             while taking Revlimid).

          -  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.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Patients with a history of embolic events (e.g. TIA) from arrhythmia or peripheral
             arterial disease or of recent MI whether or not treated with anti-platelet drug.