Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262795
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2005-12-06
Brief Title:
Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients More Than 65 Years With Advanced Chronic Lymphocytic Leukemia
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 chlorambucil 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 fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil
Compare the duration of remission in patients treated with these regimens
Secondary
Compare the incidence of toxicity especially infections in patients treated with these regimens
Compare the quality of life in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days 1-5 Treatment repeats every 28 days for up to 6 courses
Arm II Patients receive oral chlorambucil on day 1 Treatment repeats every 15 days for up to 12 months
PROJECTED ACCRUAL A total of 205 patients will be accrued for this study
Primary
Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil
Compare the duration of remission in patients treated with these regimens
Secondary
Compare the incidence of toxicity especially infections in patients treated with these regimens
Compare the quality of life in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days 1-5 Treatment repeats every 28 days for up to 6 courses
Arm II Patients receive oral chlorambucil on day 1 Treatment repeats every 15 days for up to 12 months
PROJECTED ACCRUAL A total of 205 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 |
|---|---|---|---|
| GCLLSG-73 | None | None | None |
| EU-20557 | None | None | None |
| MEDAC-GCLLSG-CLL5 | None | None | None |