Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Completed · Phase 2
Conditions studied: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma
In brief
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. ...
Key facts
- Study ID
- NCT00439231
- Run by
- Georg Aue, M.D.
- People needed
- 33
- Starts
- 2007-02-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2014-01-13
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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