Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024440
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2001-09-13
Brief Title:
Fludarabine and Cyclophosphamide With or Without Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Sponsor:
Genta Incorporated
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Study Of Fludarabine And Cyclophosphamide With Or Without Genasense Bcl-2 Antisense Oligonucleotide In Subjects With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2003-10
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 Oblimersen may help fludarabine and cyclophosphamide kill more cancer cells by making them more sensitive to the drugs It is not yet known if fludarabine and cyclophosphamide are more effective with or without oblimersen
PURPOSE Randomized phase III trial to compare the effectiveness of fludarabine and cyclophosphamide with or without oblimersen in treating patients who have relapsed or refractory chronic lymphocytic leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of fludarabine and cyclophosphamide with or without oblimersen in treating patients who have relapsed or refractory chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Compare the complete response and nodular partial response of patients with relapsed or refractory chronic lymphocytic leukemia treated with fludarabine and cyclophosphamide with or without oblimersen
Compare the overall response rate response duration survival and time to progression in patients treated with these regimens
Compare the clinical benefit and safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease response to prior fludarabine-containing therapy responsive vs refractory number of prior regimens 1-2 vs 3 or more and duration of response to last prior therapy more than 6 months vs 6 months or fewer Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oblimersen IV continuously on days 1-7 via an infusion pump ending on day 8 and fludarabine IV over 20-30 minutes and cyclophosphamide IV over 30-60 minutes on days 5-7 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 11 and continuing until blood counts recover
Arm II Patients receive fludarabine IV over 20-30 minutes followed by cyclophosphamide IV over 30-60 minutes on days 1-3 Patients also receive G-CSF SC beginning on day 7 and continuing until blood counts recover
Treatment in both arms continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month and then every 2 months for 2 years
PROJECTED ACCRUAL A total of 200 patients 100 per arm will be accrued for this study within 1 year
Compare the complete response and nodular partial response of patients with relapsed or refractory chronic lymphocytic leukemia treated with fludarabine and cyclophosphamide with or without oblimersen
Compare the overall response rate response duration survival and time to progression in patients treated with these regimens
Compare the clinical benefit and safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease response to prior fludarabine-containing therapy responsive vs refractory number of prior regimens 1-2 vs 3 or more and duration of response to last prior therapy more than 6 months vs 6 months or fewer Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oblimersen IV continuously on days 1-7 via an infusion pump ending on day 8 and fludarabine IV over 20-30 minutes and cyclophosphamide IV over 30-60 minutes on days 5-7 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 11 and continuing until blood counts recover
Arm II Patients receive fludarabine IV over 20-30 minutes followed by cyclophosphamide IV over 30-60 minutes on days 1-3 Patients also receive G-CSF SC beginning on day 7 and continuing until blood counts recover
Treatment in both arms continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month and then every 2 months for 2 years
PROJECTED ACCRUAL A total of 200 patients 100 per arm will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GENTA-GL303 | None | None | None |
| UCLA-0104008 | None | None | None |