A Phase II Study of Lenalidomide Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Lenalidomide
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Sponsor
- Georg Aue, M.D.
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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) who relapsed after their initial treatment.
Patients 21 years of age and older with CLL or SLL who have previously received standard treatment may be eligible for this study.
Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as the medicine is tolerated. After four cycles, patients who respond completely continue treatment for another two cycles; patients who respond partially continue treatment for another four cycles; and patients who do not respond stop treatment but continue to be followed for safety.
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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. A pilot clinical trial in CLL studied single agent lenalidomide cycled every 4 weeks with 25 mg for three weeks on and one week off drug. In this trial dose reductions have been necessary secondary to prolonged neutropenia or thrombocytopenia in a majority of patients. However, there was also remarkable efficacy and evidence for an immune stimulatory effect of lenalidomide. Therefore, we propose this phase II trial using 20 mg lenalidomide (Revlimid(Registered Trademark)) 3 weeks on and 3 weeks off for 4 cycles in subjects who have been previously treated for chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Subjects with at least partial response (PR) may go on to receive 4 additional cycles. The primary objective of the trial is to test the efficacy of a more tolerable dosing scheme of lenalidomide.
Investigators
Georg Aue, M.D.
NHLBI Hematolgy Clinician
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lenalidomide (Revlimid) subjects
Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects
Intervention: Lenalidomide
Outcomes
Primary Outcomes
To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
Time Frame: 24 weeks of lenalidomide therapy
To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen