Viewing Study NCT00004194



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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
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

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