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

Not Recruiting

Trial ID: NCT00963105


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).

Official Title

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

Stanford Investigator(s)

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Jason Gotlib

Professor of Medicine (Hematology)


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 ≤

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

   - 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

   - 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

   - Participation in any clinical study or having taken any investigational therapy within
   28 days prior to initiating lenalidomide therapy


drug: lenalidomide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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