Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096044
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2004-11-09
Brief Title:
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia CLL
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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 15 years
Primary
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
Secondary
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 15 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CELGENE-RV-CLL-PI-005 | OTHER_GRANT | Celgene | None |
| RPCI-I-18103 | OTHER | None | None |