Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ofatumumab; Lenalidomide
Intervention description: Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
Treatment to be administered for up to 6 cycles; -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)
Intervention MeSH terms: Lenalidomide; Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed chronic lymphocytic leukemia

Summary:

      The purpose of this research is to evaluate the safety and effectiveness of the drugs
      lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (CLL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must have confirmed diagnosis of chronic lymphocytic leukemia (CLL).

          2. Prior therapy with at least one regimen containing rituximab

          3. Age > 18 years.

          4. Life expectancy greater than 12 months.

          5. ECOG performance status <2

          6. Patients must have normal organ function as defined in the protocol.

          7. Patients must have adequate bone marrow function as defined in the protocol.

          8. Ability to understand and the willingness to sign a written informed consent document.

          9. All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

         10. 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.

         11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
             intolerant to ASA may use warfarin or low molecular weight heparin.

        Exclusion Criteria:

          1. Patients who have had chemotherapy or radiotherapy within 4 weeks or received any
             monoclonal antibody within 6 weeks prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier.

          2. Patients may not be receiving any other investigational agents or other anti-cancer
             agents or treatments.

          3. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ofatumumab or lenalidomide.

          4. Uncontrolled concomitant illness.

          5. Pregnant women are excluded from this study because lenalidomide is believed to be
             teratogenic.

          6. HIV-positive patients on combination antiretroviral therapy are ineligible because of
             the potential for pharmacokinetic interactions with ofatumumab or lenalidomide.

          7. Prior treatment with lenalidomide

          8. Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome.
             Subjects may be enrolled upon correction of electrolyte abnormalities.

          9. All patients will undergo screening for hepatitis B and may or may not be eligible
             based on the results as outlined in the protocol.