Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older
Condition: Leukemia; CLL; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide
Intervention description: Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Leukemia; CLL; chronic lymphocytic leukemia; SLL; small lymphocytic lymphoma; Untreated CLL; Lenalidomide; CC-5013; Revlimid; Oral

Summary:

      Primary Objective:

        -  To assess the activity of lenalidomide in patients with previously untreated chronic
           lymphocytic leukemia (CLL) age 65 and older.

      Secondary Objective:

        -  To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and
           older
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with untreated CLL or small lymphocytic lymphoma (SLL) with indication to
             treatment according to NCI Working Group guidelines.Patients that have received single
             agent rituximab will be allowed to participate in this study.

          2. Age 65 or older

          3. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
             status of 0-2.

          4. Adequate renal function indicated by serum creatinine less or equal to 2 and adequate
             hepatic function indicated as total bilirubin less or equal to upper level of normal
             and as alanine aminotransferase (ALT) less or equal 2 upper limit of normal (ULN).

          5. Able to understand and sign Informed Consent after the investigational nature, study
             design, risks and benefits have been explained.

          6. Able to adhere to the study visit schedule and other protocol requirements.

          7. 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.

          8. 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; 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). 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

          9. Continued from above. 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.

         10. 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.

         11. All patients must be counseled at a minimum of every 28 days about pregnancy
             precautions and risks of fetal exposure.

         12. All patients must be able to take aspirin (81 or 325 mg) daily as prophylactic
             anticoagulation (patients intolerant to Acetylsalicylic Acid (ASA) may use warfarin or
             low molecular weight heparin.

        Exclusion Criteria:

          1. Known sensitivity to thalidomide or its derivatives.

          2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).

          3. Known positivity for HIV or active hepatitis (B or C).

          4. A serious medical condition, laboratory abnormality or psychiatric illness that would
             interfere with the ability of the patient to participate in this program according to
             the judgement of the Principal Investigator.

          5. Active cardiovascular disease as defined by the New York Heart Association Class 3 or
             4.

          6. History of erythema nodosum if characterized by a desquamating rash while taking
             thalidomide or similar drugs.

          7. Concurrent use of other chemotherapy agents.

          8. Pregnant or breast feeding females. Lactating females must agree not to breast feed
             while taking lenalidomide.

          9. No known history of tuberculosis or recent exposure to tuberculosis.