Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Trial ID or NCT#
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).
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
- - 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.
- - 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
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Cancer Clinical Trials Office