Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL
Condition: Chronic Lymphocytic Leukemia(CLL); Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Revlimid; Azacitidine
Intervention description: Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and < 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily on Days 1-21).; Azacitidine 75 mg/m2 IV or SC D 1-5
Intervention MeSH terms: Lenalidomide; Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic lymphocytic leukemia (CLL); Small Lymphocytic Lymphoma

Summary:

      To determine the response to the combination of Revlimid (Lenalidomide)+ Vidaza (Azacitidine)
      in patients with relapsed/refractory CLL and SLL

      Hypothesis- lenalidomide's activity in combination with azacitidine may further enhance its
      activity and the durability of treatment response.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must be age ≥ 18 must have an ECOG PS ≤ 2 must understand and voluntarily sign
        informed consent adhere to the study protocol requirements and schedule must carry the
        diagnosis of B-CLL/SLL, SLL/CLL must be defined as relapsed or refractory disease Pts. must
        have received and failed at least one purine-based treatment regimen (ie. FCR, FR, PCR,
        Fludarabine) or alemtuzumab-based regimen or bendamustine-based regimen prior to study
        enrollment Serum bilirubin levels <1.5 times the upper limit of the normal range for the
        laboratory (ULN) Higher levels are acceptable if these can be attributed to active
        hemolysis, ineffective erythropoiesis or Gilbert's disease.Serum (SGOT) [AST])(SGPT) [ALT])
        levels <2 x ULN or <5 x ULN if hepatic metastases are present) Subjects must have
        calculated creatinine clearance ≥ 30ml/min Absolute neutrophil count > 1.0 x 109 / L
        Platelet count > 50x 109 / L (unless bone marrow is heavily infiltrated with underlying
        disease (50% or more) 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 All participants must be registered into the mandatory RevAssist®
        program Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
        intolerant to ASA may use warfarin or low molecular weight heparin) Females of childbearing
        potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of
        at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to
        prescribing lenalidomide (prescriptions must be filled within 7 days) and must either
        commit to continued abstinence from heterosexual intercourse or begin TWO acceptable
        methods of birth control, one highly effective method and one additional effective method
        AT THE SAME TIME, at least 28 days before she starts taking lenalidomide FCBP must also
        agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual
        contact with a FCBP even if they have had a successful vasectomy.

        Exclusion Criteria: - Patient must not have any serious medical condition, laboratory
        abnormality, or psychiatric illness that would places the subject at unacceptable risk or
        confound the interpretation of data from the study Patients must be lenalidomide /
        azacitidine naïve prior to study enrollment Patients must not be HIV, Hepatitis B or
        Hepatitis C positive, except for Patients who are seropositive because of hepatitis B virus
        vaccine are eligible Patients must not have received chemotherapy, immunotherapy or any
        experimental study drug for CLL or SLL at least 4 weeks prior to study enrollment and
        initiation of treatment Patients with history of B-CLL and the development of
        prolymphocytic leukemia or Richter's transformation Known or suspected hypersensitivity to
        azacitidine, mannitol, thalidomide or Lenalidomide Pregnant or breast feeding females are
        not eligible or lactating females must agree not to breast feed while taking Lenalidomide
        Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome Subjects may
        be enrolled upon correction of electrolyte abnormalities Patients with advanced malignant
        hepatic tumors; Concurrent use of other anti-cancer agents or treatments, or Uncontrolled
        systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related
        to the infection without improvement despite appropriate antibiotics or other treatment.