Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003659
Status:
COMPLETED
Last Update Posted:
2017-10-24
First Post:
1999-11-01
Brief Title:
Fludarabine Cyclophosphamide and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Fludarabine Induction With Sequential High Dose Cyclophosphamide and Rituximab as Consolidation Therapy for Previously Untreated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2017-09
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 Combining more than one drug may kill more cancer cells Monoclonal antibodies 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 plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of fludarabine plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the response rate in patients with chronic lymphocytic leukemia treated with sequential fludarabine high dose cyclophosphamide and rituximab
Survival up to 5 years
Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal residual disease in these patients
OUTLINE This is an open label study
Patients receive fludarabine IV once daily for 5 days Treatment is repeated every 4 weeks for 3 or 6 courses
Three weeks later cyclophosphamide is administered intravenously every 2-3 weeks for 3 courses Filgrastim G-CSF is administered on days 2-10 Beginning 4 weeks after the last dose of cyclophosphamide patients receive rituximab by intravenous infusion once weekly for 4 weeks
Patient are followed every 3 months until death
PROJECTED ACCRUAL This study will accrue 30 patients within 3 years
Determine the response rate in patients with chronic lymphocytic leukemia treated with sequential fludarabine high dose cyclophosphamide and rituximab
Survival up to 5 years
Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal residual disease in these patients
OUTLINE This is an open label study
Patients receive fludarabine IV once daily for 5 days Treatment is repeated every 4 weeks for 3 or 6 courses
Three weeks later cyclophosphamide is administered intravenously every 2-3 weeks for 3 courses Filgrastim G-CSF is administered on days 2-10 Beginning 4 weeks after the last dose of cyclophosphamide patients receive rituximab by intravenous infusion once weekly for 4 weeks
Patient are followed every 3 months until death
PROJECTED ACCRUAL This study will accrue 30 patients within 3 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 |
|---|---|---|---|
| NCI-G98-1483 | None | None | None |
| MSKCC-98080 | None | None | None |