Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide (REVLIMID®) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Inclusion Criteria:

• Age ≥ 18 years at the time of signing the informed consent form
• Must be able to adhere to the study visit schedule and other protocol requirements
• Must have a documented diagnosis of B-cell CLL
• Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Active infections requiring systemic antibiotics
• Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
• Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
• Prior therapy with lenalidomide
• History of grade 4 rash due to prior thalidomide treatment
• Planned autologous or allogeneic bone marrow transplantation
• Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
• Uncontrolled hyperthyroidism or hypothyroidism
• Venous thromboembolism within 12 months
• ≥ Grade 2 neuropathy
• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
• Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
• Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy