Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276848
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2006-01-12
Brief Title:
Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients Up to 65 Years With Advanced Chronic Lymphocytic Leukemia CLL
Status:
COMPLETED
Status Verified Date:
2019-05
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 It is not yet known whether giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival as well the overall survival and duration of remission in patients with previously untreated advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide
Secondary
Compare the incidence of side effects and quality of life of patients treated with these drugs
OUTLINE This is a multicenter randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days 1-5
Arm II Patients receive fludarabine IV and cyclophosphamide IV on days 1-3 In both arms treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 375 patients will be accrued for this study
Primary
Compare the progression-free survival as well the overall survival and duration of remission in patients with previously untreated advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide
Secondary
Compare the incidence of side effects and quality of life of patients treated with these drugs
OUTLINE This is a multicenter randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days 1-5
Arm II Patients receive fludarabine IV and cyclophosphamide IV on days 1-3 In both arms treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 375 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 |
|---|---|---|---|
| CDR0000455094 | OTHER | Clinical Data Repository | None |
| EU-20538 | None | None | None |
| GCLLSG-153 | None | None | None |
| ISRCTN75653261 | None | None | None |
| MEDAC-GCLLSG-CLL4 | None | None | None |