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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Graft-Versus-Host Disease

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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