Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Treatments: Pentostatin

Criteria

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.