Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096018
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2004-11-09
Brief Title:
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase III Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-09
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 work in different ways to stop cancer cells from dividing so they stop growing or die Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing Combining fludarabine with thalidomide may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia
PURPOSE This phase III trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of fludarabine and thalidomide in patients with newly diagnosed B-cell chronic lymphocytic leukemia
Determine the overall response rate complete and partial in patients treated with this regimen
Determine the duration of response in patients treated with this regimen
OUTLINE This is an open-label phase I dose-escalation study of thalidomide followed by a phase II study
Phase I Beginning on day 1 patients receive oral thalidomide once daily for up to 6 months Beginning on day 7 patients also receive fludarabine IV over 30 minutes daily for 5 days Treatment with fludarabine repeats every 28-35 days for up to 6 courses Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of thalidomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive fludarabine and thalidomide as in phase I at the MTD
Patients are followed at 4 weeks every 3 months for 2 years and then every 4 months for 2 years
PROJECTED ACCRUAL Up to 45 patients 9 for the phase I portion and 36 for the phase II portion will be accrued for this study within 8 years
Determine the safety and efficacy of fludarabine and thalidomide in patients with newly diagnosed B-cell chronic lymphocytic leukemia
Determine the overall response rate complete and partial in patients treated with this regimen
Determine the duration of response in patients treated with this regimen
OUTLINE This is an open-label phase I dose-escalation study of thalidomide followed by a phase II study
Phase I Beginning on day 1 patients receive oral thalidomide once daily for up to 6 months Beginning on day 7 patients also receive fludarabine IV over 30 minutes daily for 5 days Treatment with fludarabine repeats every 28-35 days for up to 6 courses Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of thalidomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive fludarabine and thalidomide as in phase I at the MTD
Patients are followed at 4 weeks every 3 months for 2 years and then every 4 months for 2 years
PROJECTED ACCRUAL Up to 45 patients 9 for the phase I portion and 36 for the phase II portion will be accrued for this study within 8 years
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 |
|---|---|---|---|
| RPC-01-12 | None | None | None |