Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide; Rituximab
Intervention description: Started on Day 9 of Cycle 1 at the dose of 10 mg/day and continued daily. Treatment duration will be twelve cycles.; Dose of 375 mg/m^2 given intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2.
Intervention MeSH terms: Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; CLL; Chronic Lymphocytic Leukemia; SLL; Small Lymphocytic Lymphoma; Lenalidomide; Revlimid; Rituximab; Rituxan

Summary:

      The goal of this clinical research study is to learn if the combination of lenalidomide and
      rituximab can help to control Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic
      Lymphoma (SLL) in patients who have already received therapy. The safety of this drug
      combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
             with active disease.

          2. Patients must be age 18 or over at the signing of consent and must understand and
             voluntarily sign an informed consent.

          3. Prior treatment with purine analog based chemotherapy or chemoimmunotherapy.

          4. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
             status of 0-2.

          5. Adequate renal function indicated by serum creatinine less or equal to 2 mg/dl.
             Adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and
             ALT less or equal to two times the upper limit of normal.

          6. Disease free of prior malignancies for 3 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 or surgery can be enrolled in the study as long as they have a
             reasonable expectation to have been cured with the treatment modality received.

          7. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test (sensitivity of at least 50 milli-International unit (mIU/mL) 10-14 days prior to
             starting lenalidomide. 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).

          8. Continued from Criteria #7. FCBP 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 talking lenalidomide. FCBP must also agree to ongoing pregnancy
             testing.

          9. Continued from Criteria #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.

         10. Men must agree not to father a child. They must agree to use a latex condom during
             sexual contact with females of childbearing potential while participating in the study
             and for at least 28 days following discontinuation from the study even if he has
             undergone a vasectomy. They will be warned that sharing study drug is prohibited and
             will be counseled about pregnancy precautions and potential risks of fetal exposure.
             They must agree to abstain from donating blood, semen, or sperm during study
             participation and for at least 28 days after discontinuation from the study.

         11. Continued from Criteria #10: Counseling about the requirement for latex condom use
             during sexual contact with females of childbearing potential and the potential risks
             of fetal exposure must be conducted at a minimum of every 28 days. During counseling,
             subjects must be reminded not to share study drug and to not donate blood, sperm, or
             semen (during study participation and for 28 days following discontinuation from the
             study).

        Exclusion Criteria:

          1. Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.

          2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).

          3. Known positivity for HIV or active hepatitis (B or C).

          4. Pregnant or breast feeding females.

          5. History of tuberculosis treated within the last five years or recent exposure to
             tuberculosis.

          6. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             places the subject at unacceptable risk if he/she were to participate in the study.

          7. Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus
             (PE), in the six months prior to enrollment are not eligible for this study.