Status:
COMPLETED
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Graft-Versus-Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
Eligibility Criteria
Inclusion
- Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids
- No chronic GVHD
- Age ≥ 18 years
- Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l)
- Performance status 0-3
Exclusion
- Patients on mechanical ventilation or who have resting O2 saturation \<90% by pulse-oximetry.
- Patients on renal dialysis or who have an estimated creatinine clearance of \< 30 ml/min/1.73 m2.
- Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00201786
Start Date
July 1 2003
End Date
July 1 2013
Last Update
April 27 2016
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210