Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)

Exclusion Criteria

• •1. Prior treatment for B-cell CLL.
• •2. Any medical condition, that would prevent the subject from signing the informed consent form.
• •3. Active infections requiring systemic antibiotics.
• •4. Systemic infection that has not resolved \> 2 months prior to initiating lenalidomide
• •5. Pregnant or lactating females.
• •6. Participation in any clinical study or having taken any investigational therapy within 28 days.
• •7. Known presence of alcohol and/or drug abuse.
• •8. Central nervous system (CNS) involvement.
• •9. Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥3 years. Exceptions include the following:
• •* Basal cell carcinoma of the skin
• •* Squamous cell carcinoma of the skin
• •* Carcinoma in situ of the cervix
• •* Carcinoma in situ of the breast
• •* Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
• •10. History of renal failure requiring dialysis.
• •11. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
• •12. Prior therapy with lenalidomide.
• •13. Evidence of TLS at screening
• •14. Presence of specific hematology and/or chemistry abnormalities
• •15. Uncontrolled hyperthyroidism or hypothyroidism
• •16. Venous thromboembolism within one year
• •17. ≥ Grade-2 neuropathy
• •18. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
• •19. Disease transformation \[i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia\]