Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004857
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2000-03-07
Brief Title:
Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2016-07
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 use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the overall response rate of previously untreated patients with stage I II III or IV B-cell chronic lymphocytic leukemia when treated with fludarabine induction followed by alemtuzumab consolidation II Determine the infectious toxic effects and feasibility of this regimen in this patient population III Determine the treatment-related toxic effects including infection and injection site reactions of subcutaneous vs intravenous alemtuzumab in patients treated with this regimen IV Determine the progression-free and overall survival of patients treated with this regimen V Determine the immunologic effects of this regimen in these patients
OUTLINE Patients receive fludarabine IV over 30 minutes 5 days a week Treatment repeats every 28 days for 4 courses in the absence of disease progression Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation Patients are followed every 3 months for 1 year and then every 6 months for 8 years
OUTLINE Patients receive fludarabine IV over 30 minutes 5 days a week Treatment repeats every 28 days for 4 courses in the absence of disease progression Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation Patients are followed every 3 months for 1 year and then every 6 months for 8 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 |
|---|---|---|---|
| CDR0000067506 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |