Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004194
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2000-01-21
Brief Title:
Fludarabine in Treating Patients With Steroid-Resistant Chronic Graft- Versus-Host Disease
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine
Status:
UNKNOWN
Status Verified Date:
2000-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Fludarabine may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation
PURPOSE Phase III trial to study the effectiveness of fludarabine in treating patients who have chronic graft-versus-host disease that has not responded to steroid therapy
PURPOSE Phase III trial to study the effectiveness of fludarabine in treating patients who have chronic graft-versus-host disease that has not responded to steroid therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose toxicity and efficacy of fludarabine in patients with steroid resistant chronic graft versus host disease
OUTLINE This is a dose escalation study Phase I Patients receive fludarabine IV over less than 30 minutes for 1-3 days Treatment repeats every 4 weeks for up to 4 courses in the absence of relapse of underlying disease malignancy graft rejection or unacceptable toxicity Patients with progressive graft versus host disease after completion of 3 courses are taken off study Patients with complete response are taken off study Patients with partial response may continue treatment at the immediate prior dose level Cohorts 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity Phase II Patients receive fludarabine at the MTD from phase I of the study
PROJECTED ACCRUAL A total of 15-27 patients will be accrued for this study
OUTLINE This is a dose escalation study Phase I Patients receive fludarabine IV over less than 30 minutes for 1-3 days Treatment repeats every 4 weeks for up to 4 courses in the absence of relapse of underlying disease malignancy graft rejection or unacceptable toxicity Patients with progressive graft versus host disease after completion of 3 courses are taken off study Patients with complete response are taken off study Patients with partial response may continue treatment at the immediate prior dose level Cohorts 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity Phase II Patients receive fludarabine at the MTD from phase I of the study
PROJECTED ACCRUAL A total of 15-27 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 |
|---|---|---|---|
| NCI-G99-1650 | None | None | None |
| UCLA-9701029 | None | None | None |