Status:
COMPLETED
Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Lead Sponsor:
Georg Aue, M.D.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and effectiveness of a new drug called lenalidomide (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) wh...
Detailed Description
There is evidence that lenalidomide has single agent activity in chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Optimal dosing of lenalidomide in CLL has not been established yet...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
- Failed prior standard of care therapy for CLL.
- Neutrophil count (ANC) greater than or equal to 500/microliter (mcL).
- Platelet count greater than or equal to 20,000/mcL.
- Age 21-99.
- EXCLUSION CRITERIA:
- Chronic or current clinically significant infection, including HIV positivity or uncontrolled infection.
- Eastern Cooperative Oncology Group (ECOG) performance greater than 2.
- Other concurrent anticancer therapies.
- Less than 4 weeks from last systemic therapy for CLL. Steroids up to 2 weeks before the start of treatment are permissible.
- Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy.
- Creatinine greater than 1.5 times the upper limit of normal.
- Women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception.
- Men who are unwilling to use a barrier protection.
- Inability to understand the investigational nature of the study; inability to provide informed consent.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00439231
Start Date
February 1 2007
End Date
November 1 2010
Last Update
January 13 2014
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892