Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086775
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2004-07-08
Brief Title:
Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia
Sponsor:
Bayer
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy
Status:
COMPLETED
Status Verified Date:
2009-10
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 Drugs used in chemotherapy such as fludarabine work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as alemtuzumab and rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Compare the complete response rate in patients with refractory or relapsed B-cell chronic lymphocytic leukemia treated with fludarabine and alemtuzumab vs fludarabine and rituximab
Secondary
Compare the overall response rate in patients treated with these regimens
Compare 1-year survival of patients treated with these regimens
Compare time to progression in patients treated with these regimens
Compare duration of response in patients treated with these regimens
Compare the adverse event profile of these regimens in these patients
Compare the molecular response rate in patients treated with these regimens
Compare lymphocyte and lymphocyte subset recovery CD3 CD3CD4 CD3CD8 CD20 in patients treated with these regimens
Compare the time to complete response in patients treated with these regimens
Compare the rate of cytomegalovirus reactivation and time to reactivation in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to prior treatment with fludarabine yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV over 30 minutes on days 1-5 At least 30 minutes before fludarabine administration patients receive alemtuzumab subcutaneously SC on days 1-5
Arm II Patients receive fludarabine as in arm I At least 30 minutes before fludarabine administration patients receive rituximab IV on days 1 and 4 of course 1 and on day 1 only in subsequent courses
In both arms treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity An interim assessment is performed during course 4 Patients achieving a partial response or stable disease receive 2 additional courses of therapy for a total of 6 courses Patients achieving a complete response CR do not receive further treatment beyond CR
Patients are followed weekly for 2 months monthly for 6 months every 2 months for 6 months and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm will be accrued for this study
Primary
Compare the complete response rate in patients with refractory or relapsed B-cell chronic lymphocytic leukemia treated with fludarabine and alemtuzumab vs fludarabine and rituximab
Secondary
Compare the overall response rate in patients treated with these regimens
Compare 1-year survival of patients treated with these regimens
Compare time to progression in patients treated with these regimens
Compare duration of response in patients treated with these regimens
Compare the adverse event profile of these regimens in these patients
Compare the molecular response rate in patients treated with these regimens
Compare lymphocyte and lymphocyte subset recovery CD3 CD3CD4 CD3CD8 CD20 in patients treated with these regimens
Compare the time to complete response in patients treated with these regimens
Compare the rate of cytomegalovirus reactivation and time to reactivation in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to prior treatment with fludarabine yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV over 30 minutes on days 1-5 At least 30 minutes before fludarabine administration patients receive alemtuzumab subcutaneously SC on days 1-5
Arm II Patients receive fludarabine as in arm I At least 30 minutes before fludarabine administration patients receive rituximab IV on days 1 and 4 of course 1 and on day 1 only in subsequent courses
In both arms treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity An interim assessment is performed during course 4 Patients achieving a partial response or stable disease receive 2 additional courses of therapy for a total of 6 courses Patients achieving a complete response CR do not receive further treatment beyond CR
Patients are followed weekly for 2 months monthly for 6 months every 2 months for 6 months and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DMS-F0334 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000365631 | REGISTRY | None | None |
| BRLX-STA1-03-058 | None | None | None |
| OHSU-HEM-03050-P | None | None | None |