Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Graft-Versus-Host Disease
Both
Graft-Versus-Host Disease
Trial Information
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD.
Outcome Time Frame:
2003-present
Safety Issue:
Yes
Principal Investigator
Craig Hofmeister, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Institutional Review Board
Study ID:
OSU-0301
NCT ID:
NCT00201786
Start Date:
July 2003
Completion Date:
Related Keywords:
- Graft-Versus-Host Disease
- Corticosteroids
- Graft vs Host Disease
Name | Location |
|---|---|
| Ohio State University | Columbus, Ohio 43210 |
