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

• Status: Completed
• Trial end date: 2017-09-05
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

Criteria

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