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

The Ohio State University logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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