Back to resultsPhase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
Primary Purpose
Graft-Versus-Host Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pentostatin
Sponsored by
About this trial
This is an interventional treatment trial for Graft-Versus-Host Disease focused on measuring Corticosteroids
Eligibility Criteria
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.
Sites / Locations
- Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pentostatin
Arm 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.
Outcomes
Primary Outcome Measures
Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).
Secondary Outcome Measures
Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC).
Full Information
NCT ID
NCT00201786
First Posted
September 12, 2005
Last Updated
April 25, 2016
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00201786
Brief Title
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
Official Title
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-Versus-Host Disease
Keywords
Corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pentostatin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pentostatin
Other Intervention Name(s)
(Nipent®, Supergen)
Intervention 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. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Hofmeister, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23588536
Citation
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-versus-host disease. Clin Pharmacokinet. 2013 Aug;52(8):705-12. doi: 10.1007/s40262-013-0064-7.
Results Reference
result
Links:
URL
http://cancer.osu.edu
Description
Jamesline
Learn more about this trial
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
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