Fludarabine in Treating Patients With Steroid-Resistant Chronic Graft- Versus-Host Disease
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|ClinicalTrials.gov Identifier: NCT00004194|
Recruitment Status : Unknown
Verified April 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 16, 2004
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: fludarabine phosphate||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004194
|Study Chair:||Christos E. Emmanouilides, MD||Jonsson Comprehensive Cancer Center|