Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide
Intervention description: 10 mg/day, orally once a day for 28 days
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Lenalidomide; Revlimid; CLL

Summary:

      The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to
      control CLL in patients who have already received standard therapy. The safety of
      lenalidomide will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with B-cell CLL with indications for treatment by National Cancer Institute
             (NCI) Working Group Criteria, or Rai Stage III or IV or patients with CLL requiring
             treatment because of any of the following: disease related symptoms, progressive
             marrow failure (development or worsening of anemia and/or patients' thrombocytopenia)
             progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis

          2. Patients who have received a minimum of one prior purine analog-based chemotherapy
             regimen. Prior treatment with corticosteroids, immunotherapy, monoclonal antibody or
             radiation therapy is permitted. All previous cancer therapy, including radiation,
             hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in
             this study. Any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment
             in this study.

          3. Age more or equal to 18 years (CLL is not observed in patients less than 18 years of
             age).

          4. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
             status 0-2.

          5. Adequate renal function indicated by serum creatinine less or equal to 2 and adequate
             hepatic function indicated as total bilirubin less or equal to 2 times the upper limit
             of normal.

          6. Understand and sign Informed Consent after the investigational nature, study design,
             risks and benefits of the study have been explained.

          7. 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 of starting lenalidomide 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 4 weeks before she starts taking lenalidomide. FCBP must also agree to
             ongoing pregnancy testing.

          8. Continued from #7. Men must agree to use a condom during sexual contact with a female
             of child bearing potential 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. Continued from #8. A female of childbearing potential is a sexually mature woman who:
             1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
             naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at
             any time in the preceding 24 consecutive months).

         10. Disease free of prior malignancies for 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
             or breast. Patients with malignancies with indolent behavior such as prostate cancer
             treated with radiation can be enrolled in the study as long as they have a reasonable
             expectation to have been cured with treatment modality received.

        Exclusion Criteria:

          1. Known sensitivity to thalidomide or its derivatives

          2. The development of erythema nodosum as characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          3. Prior use of lenalidomide

          4. Concurrent use of other chemotherapy agents.

          5. Known positivity for Human immunodeficiency virus (HIV) or infectious hepatitis type
             A, B or C.

          6. Pregnant or lactating females.

          7. A serious medical condition, laboratory abnormality or psychiatric illness that would
             pose the subject at unacceptable risk if he/she were to participate in the study or
             that would interfere with the ability of the patient to carry out the treatment
             program or confine the ability to interpret the data from the study.

          8. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).

          9. Active cardiovascular disease as defined by the New York Heart Association class 3 or
             4.