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Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD) (SUPPORTS)

Primary Purpose

Acute Gastrointestinal Graft vs Host Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
oral beclomethasone 17,21-dipropionate
Placebo
Sponsored by
Soligenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastrointestinal Graft vs Host Disease focused on measuring BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant, marrow transplant, SCT, beclomethasone 17,21-dipropionate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Receipt of allogeneic hematopoietic cell transplant
  • Diagnosis of GI graft vs. host disease (GVHD)
  • No GI infection
  • Must be able to swallow tablets
  • Must be able to read and understand informed consent
  • Adequate birth control methods for the duration of the study

Exclusion Criteria:

  • Significant Skin GVHD
  • Liver GVHD
  • Persistent vomiting
  • HIV positive
  • Pregnancy/lactation

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

orBec®

Placebo

Arm Description

Investigational drug

Control

Outcomes

Primary Outcome Measures

The Proportion of Subjects With GVHD Treatment Failure
The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD

Secondary Outcome Measures

Cumulative Exposure to Prednisone
Survival Status

Full Information

First Posted
June 19, 2009
Last Updated
October 10, 2013
Sponsor
Soligenix
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1. Study Identification

Unique Protocol Identification Number
NCT00926575
Brief Title
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Acronym
SUPPORTS
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal GVHD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
An independent Data Safety Monitoring Board recommended the study be stopped due to futility
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soligenix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastrointestinal Graft vs Host Disease
Keywords
BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant, marrow transplant, SCT, beclomethasone 17,21-dipropionate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
orBec®
Arm Type
Experimental
Arm Description
Investigational drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control
Intervention Type
Drug
Intervention Name(s)
oral beclomethasone 17,21-dipropionate
Other Intervention Name(s)
orBec, BDP
Intervention Description
Two tablets QID for 50 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two tablets QID for 50 days
Primary Outcome Measure Information:
Title
The Proportion of Subjects With GVHD Treatment Failure
Description
The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD
Time Frame
Day 80
Secondary Outcome Measure Information:
Title
Cumulative Exposure to Prednisone
Time Frame
Day 80
Title
Survival Status
Time Frame
Day 200

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receipt of allogeneic hematopoietic cell transplant Diagnosis of GI graft vs. host disease (GVHD) No GI infection Must be able to swallow tablets Must be able to read and understand informed consent Adequate birth control methods for the duration of the study Exclusion Criteria: Significant Skin GVHD Liver GVHD Persistent vomiting HIV positive Pregnancy/lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Sullivan, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Hockenbery, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
City
Buffalo
State/Province
New York
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9649455
Citation
McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35. doi: 10.1016/s0016-5085(98)70361-0.
Results Reference
background
PubMed Identifier
17244684
Citation
Hockenbery DM, Cruickshank S, Rodell TC, Gooley T, Schuening F, Rowley S, David D, Brunvand M, Berryman B, Abhyankar S, Bouvier M, McDonald GB. A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood. 2007 May 15;109(10):4557-63. doi: 10.1182/blood-2006-05-021139. Epub 2007 Jan 23.
Results Reference
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Learn more about this trial

Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

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