A Two-Arm, Multi-center Trial of Revlimid® and Rituximab, for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria:

1. Diagnosis of chronic lymphocytic leukemia (CLL).

2. Subjects must have active disease appropriate for therapy.

3. Previous treatment for CLL

4. Understand and voluntarily sign an informed consent form.

5. Age ≥18 years at the time of signing the informed consent form.

6. Able to adhere to the study visit schedule and other protocol requirements.

7. ECOG performance status of ≤ 2 at study entry (see Appendix B).

8. Laboratory test results within these ranges: Absolute neutrophil count ≥ 1.0 x
109/L,Platelet count ≥ 50 x 109/L, Total bilirubin ≤ 1.5 mg/dL, AST (SGOT) and ALT
(SGPT) ≤ 2 x ULN, Creatinine clearance estimated to be ≥ 30 ml/min

9. Disease free of prior malignancies for ≥ 2 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma in situ" of the cervix
or breast.

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 of starting Revlimid® 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 Revlimid®. 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. All patients must
be counseled at a minimum of every 28 days about pregnancy precautions and risks of
fetal exposure. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines
and Acceptable Birth Control Methods, AND also Appendix: Education and Counseling
Guidance Document.

Exclusion Criteria:

1. Known Hepatitis B Ag positive, Hepatitis C positive patients.

2. Known HIV positive patients.

3. Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune
thrombocytopenia (ITP).

4. Inability to provide informed consent.

5. Concurrent malignancy (excluding basal and squamous cell skin cancers).

6. Active fungal, bacterial, and/or viral infection.

7. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

8. Pregnant or breast-feeding females. (Lactating females must agree not to breast feed
while taking Revlimid®).

9. 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.

10. Use of any other experimental drug or therapy within 28 days of baseline.

11. Known hypersensitivity to thalidomide.

12. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

13. Concurrent use of other anti-cancer agents or treatments.

14. Patients with history of deep venous thrombus or pulmonary embolism. Patients who are
at increased risk of thrombosis during treatment with Revlimid® including those
taking concurrent erythropoietin, darbepoetin or high-dose corticosteroids are also
excluded.

15. Patients with a history of embolic events (e.g. TIA) from arrhythmia or peripheral
arterial disease or of recent mycocardial infarction whether or not treated with
anti-platelet drugs.