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Completed

NCT Number: NCT00201786

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

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

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pentostatin

Drug

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. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).

Other names: (Nipent®, Supergen)

Primary outcomes

  1. Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).

    Time frame: up to 2 years

Secondary outcomes

  1. Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC).

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2013
First posted
Sep 20, 2005
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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