Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD - Full Text View

Purpose

Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under control undergo a rapid prednisone taper over 7 days, while study drug is continued to study day 50. After discontinuation of study drug at study day 50, patients are followed for 30 additional days, to study day 80. The primary endpoint is treatment failure by day 50, that is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone while maintaining control of intestinal GVHD.

Condition	Intervention	Phase
Graft Vs Host Disease Gastrointestinal Graft-Versus-Host Disease	Drug: Oral beclomethasone dipropionate (drug)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Placebo-Controlled, Multi-Center Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal Graft Vs. Host Disease

Resource links provided by NLM:

MedlinePlus related topics: Steroids

Drug Information available for: Prednisone Beclomethasone dipropionate Beclomethasone dipropionate monohydrate

U.S. FDA Resources

Further study details as provided by Enteron Pharmaceuticals:

Primary Outcome Measures:

Treatment failure (that is, flares of GVHD requiring immunosuppressive drug therapy) at study day 50.

Secondary Outcome Measures:

Treatment failure at study day 80.
Survival at transplant day 200.
Adverse events.

Estimated Enrollment:	130
Study Start Date:	July 2001
Estimated Study Completion Date:	December 2004

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Allogeneic hematopoietic cell transplant ≥10 days prior to screening
Symptoms consistent with Grade II intestinal GVHD
Diagnosis of GVHD confirmed by biopsy
Confirmed absence of intestinal infection
Demonstrated ability to swallow 2 tablets of the size and configuration of study drug
Anti-candidal prophylaxis of the oropharynx
If female and of childbearing potential, willing to use contraception
Ability to read, understand, and sign informed consent

Exclusion Criteria:

Skin GVHD other than a slowly evolving skin rash that involves ≤50% of body surface
Liver GVHD with total serum bilirubin >3 mg/dL
Negative intestinal biopsy for GVHD
Systemic prescription corticosteroid use within 30 days
Persistent vomiting of oral intake the precludes ingestion of study drug tablets
Multiorgan failure
Infection of the mouth or esophagus with a fungal organism
Known HIV seropositivity
Pregnancy or lactation
Previous use of BDP tablets, capsules, or inhalation products
Use of any investigational drug, biologic, or device within 30 days
Inability to comply with study procedures and scheduled study visits

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233896

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Enteron Pharmaceuticals

Investigators

Study Director:	Timothy C. Rodell, M.D.	Enteron Pharmaceuticals, Inc., a subsidiary of DOR BioPharma
Study Director:	Scott Cruickshank, Ph.D.	Enteron Pharmaceuticals Inc, a subsidiary of DOR BioPharma

More Information

Publications:

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.

Baehr PH, Levine DS, Bouvier ME, Hockenbery DM, Gooley TA, Stern JG, Martin PJ, McDonald GB. Oral beclomethasone dipropionate for treatment of human intestinal graft-versus-host disease. Transplantation. 1995 Dec 15;60(11):1231-8.

ClinicalTrials.gov Identifier:	NCT00233896 History of Changes
Other Study ID Numbers:	ENT 00-02
Study First Received:	October 4, 2005
Last Updated:	October 4, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Enteron Pharmaceuticals:

Hematopoietic cell transplant
Acute graft-vs.-host disease
Gastrointestinal tract
Randomized trial

Topical corticosteroid
Beclomethasone dipropionate
Prednisone
Survival

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases
Beclomethasone
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013