Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
- Registration Number
- NCT00201786
- Brief Summary
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pentostatin Pentostatin Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS.
- Primary Outcome Measures
Name Time Method Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease). up to 2 years
- Secondary Outcome Measures
Name Time Method Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC). up to 2 years
Trial Locations
- Locations (1)
Ohio State University
🇺🇸Columbus, Ohio, United States