Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)|
- Number of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) at 6 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Number of patients achieving a CR, PR, or SD [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Number, type, and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Oral Lenalidomide
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
- 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 CR.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096044
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Kelvin Lee, MD||Roswell Park Cancer Institute|