Lenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide
Intervention description: 10 mg daily given for 12 months
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CLL; Lenalidomide; Revlimid

Summary:

      The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to
      reduce the level of leukemia in your body. The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients should have completed their chemotherapy 3 months prior to start of treatment
             with lenalidomide and not more than 9 months prior to treatment initiation.

          2. Patients with CLL/Small Lymphocytic Lymphoma (SLL) that achieve a complete or stable
             partial remission after combination of chemotherapy. Patients in complete remission
             need to have documentation of residual disease by immunophenotyping and/or PCR
             molecular testing.

          3. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) status of
             0-2.

          4. Adequate renal and hepatic function (creatinine equal to or less than 2mg/dL - total
             bilirubin equal to or less than 2).

          5. Females of childbearing potential (FCBP). A female of childbearing potential is a
             sexually mature woman who: 1) has not undergone a hysterectomy or bilateral
             oophorectomy; 2) or has not been naturally postmenopausal for at least 24 consecutive
             months (has NOT had menses at any time in the preceding 24 consecutive months).

          6. 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 of starting
             lenalidomide and must either commit to continued abstinence from heterosexual
             intercourse or begin TWO acceptable methods of birth control; one highly effective and
             one additional effective method AT THE SAME TIME at least 28 days before starting
             taking lenalidomide.

          7. FCBP must also agree to ongoing pregnancy testing weekly for the first four weeks and
             then every 28 days while on therapy and at discontinuation of treatment.

          8. Men must agree to use a latex condom during sexual contact with a FCBP even if they
             have had a successful vasectomy. All patients must be counseled at a minimum of every
             28 days about pregnancy precautions and risks of fetal exposure.

          9. Age 18 and older.

         10. Signed, written IRB-approved informed consent.

        Exclusion Criteria:

          1. Known sensitivity to lenalidomide or thalidomide or it's derivatives

          2. Known positivity for HIV or active hepatitis B or C.

          3. Pregnant or breast feeding females. Lactating females must agree not to breast feed
             while taking lenalidomide.

          4. History of tuberculosis within the last five years or recent exposure to tuberculosis
             equal to or less than 6 months.

          5. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          6. 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.

          7. Use of any other experimental drug or therapy within 28 days of baseline.

          8. Concurrent use of other anti-cancer agents or treatments