NCT00004194

Fludarabine in Treating Patients With Steroid-Resistant Chronic Graft- Versus-Host Disease

A Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Fludarabine may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation. PURPOSE: Phase I/II 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.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	fludarabine phosphate

Timeline

• First posted: 2004-09-16
• Last updated: 2013-12-18