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

Graft-Versus-Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201786
• Other study ID #: OSU-0301
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: April 25, 2016
• Start date: July 2003
• Est. completion date: July 2013

Study information

• Verified date: April 2016
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2013
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

Drug:
• Pentostatin
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).

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Poi MJ, Hofmeister CC, Johnston JS, Edwards RB, Jansak BS, Lucas DM, Farag SS, Dalton JT, Devine SM, Grever MR, Phelps MA. Standard pentostatin dose reductions in renal insufficiency are not adequate: selected patients with steroid-refractory acute graft- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).		up to 2 years	Yes
Secondary	Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC).		up to 2 years	Yes

External Links

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