Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281931
Status:
TERMINATED
Last Update Posted:
2016-09-26
First Post:
2006-01-24
Brief Title:
Fludarabine Cyclophosphamide and Rituximab in Treating Patients With Prolymphocytic Leukemia
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
Phase II Trial of Combined Immunochemotherapy With Fludarabine Cyclophosphamide and Rituximab in Patients With B-PLL
Status:
TERMINATED
Status Verified Date:
2016-09
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 such as fludarabine and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some find cancer cells and kill them or carry cancer-killing substances to them Others interfere with the ability of cancer cells to grow and spread Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the overall and progression-free survival of patients with B-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine cyclophosphamide and rituximab
Determine the toxic effects of this regimen in these patients
OUTLINE This is a non-randomized open-label multicenter study
Patients receive fludarabine IV and cyclophosphamide IV on days 1-3 Patients also receive rituximab IV on day 0 in course 1 and on day 1 in courses 2-6 Treatment repeats every 28 days for up to 6 courses
PROJECTED ACCRUAL A total of 21 patients will be accrued for this study
Determine the overall and progression-free survival of patients with B-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine cyclophosphamide and rituximab
Determine the toxic effects of this regimen in these patients
OUTLINE This is a non-randomized open-label multicenter study
Patients receive fludarabine IV and cyclophosphamide IV on days 1-3 Patients also receive rituximab IV on day 0 in course 1 and on day 1 in courses 2-6 Treatment repeats every 28 days for up to 6 courses
PROJECTED ACCRUAL A total of 21 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20563 | None | None | None |