Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416910
Status:
TERMINATED
Last Update Posted:
2016-09-26
First Post:
2006-12-27
Brief Title:
Combination Chemotherapy With or Without G-CSF in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
Treatment of Advanced Chronic Lymphocytic Leukemia CLL Fludarabine Mitoxantrone and Cyclophosphamide With or Without G-CSF
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment
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 mitoxantrone and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells Colony stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of combination chemotherapy It is not yet known whether giving combination chemotherapy alone is more effective than combination chemotherapy together with G-CSF in treating patients with chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying giving combination chemotherapy together with G-CSF to see how well it works compared to giving combination chemotherapy alone in treating patients with relapsed stage I stage II stage III or stage IV chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying giving combination chemotherapy together with G-CSF to see how well it works compared to giving combination chemotherapy alone in treating patients with relapsed stage I stage II stage III or stage IV chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Compare the rate of remission severe infections and side effects in patients with relapsed advanced chronic lymphocytic leukemia treated with fludarabine mitoxantrone hydrochloride and cyclophosphamide with vs without filgrastim
Secondary
Compare the overall survival progression-free survival and quality of remission in these patients
OUTLINE This is a multicenter randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days 1-3 mitoxantrone hydrochloride IV on day 1 and cyclophosphamide IV on days 1-3
Arm II Patients receive fludarabine mitoxantrone hydrochloride and cyclophosphamide as in arm I and filgrastim G-CSF beginning on day 6 and continuing until blood counts recover
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 165 patients will be accrued for this study
Primary
Compare the rate of remission severe infections and side effects in patients with relapsed advanced chronic lymphocytic leukemia treated with fludarabine mitoxantrone hydrochloride and cyclophosphamide with vs without filgrastim
Secondary
Compare the overall survival progression-free survival and quality of remission in these patients
OUTLINE This is a multicenter randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days 1-3 mitoxantrone hydrochloride IV on day 1 and cyclophosphamide IV on days 1-3
Arm II Patients receive fludarabine mitoxantrone hydrochloride and cyclophosphamide as in arm I and filgrastim G-CSF beginning on day 6 and continuing until blood counts recover
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 165 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 |
|---|---|---|---|
| MEDAC-GCLLSG-CLL6 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000455571 | REGISTRY | None | None |
| EU-20558 | None | None | None |
| AMGEN-GCLLSG-CLL6 | None | None | None |