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

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Graft-Versus-Host Disease

Treatments: Drug: Pentostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00201786

OSU-0301

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Pentostatin

Experimental group

Description:

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.

Treatment:

Drug: Pentostatin