Graft Versus Host Disease Clinical Trial
Official title:
A Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine
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.
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.
;
Primary Purpose: Supportive Care
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