CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
- Determine the best cytostatic response rate (including complete response, partial
response, or stable disease) in patients with relapsed or refractory chronic
lymphocytic leukemia treated with lenalidomide (CC-5013).
- Determine the cytostatic response rate in patients who progress on CC-5013 and are then
treated with CC-5013 and rituximab.
- Determine the safety of these regimens in these patients.
- Determine time to progression in patients treated with these regimens.
OUTLINE: This is an open-label, non-randomized, pilot study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond
Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab
IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all
subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of
further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) at 6 months
Kelvin Lee, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|