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Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00043147
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Beclomethasone combined with prednisone may be an effective treatment for graft-versus-host disease caused by stem cell transplantation. It is not yet known if prednisone is more effective with or without beclomethasone in treating gastrointestinal graft-versus-host disease.

PURPOSE: Randomized phase III trial to determine the effectiveness of prednisone with or without beclomethasone in treating patients who have graft-versus-host disease afftecting the gastrointestinal system.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Drug: beclomethasone dipropionate Drug: methylprednisolone Drug: prednisone Phase 3

Detailed Description:


  • Compare the efficacy of beclomethasone dipropionate and prednisone vs placebo and prednisone, in terms of time to treatment failure, in patients with grade II graft-vs-host disease with gastrointestinal symptoms.
  • Compare the proportion of treatment failures on study days 10, 30, 50, 60, and 80 in patients treated with these regimens.
  • Compare the cumulative systemic corticosteroid exposure in patients treated with these regimens.
  • Compare the incidence and degree of hypothalamic-pituitary-adrenal axis suppression in patients treated with these regimens who have not experienced treatment failure by study day 50.
  • Compare the safety of these regimens in these patients.
  • Compare the total deaths and causes of death through 200 days post-transplantation of patients treated with these regimens.
  • Assess the pharmacokinetic profile of beclomethasone dipropionate in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel, multicenter study. Patients are stratified according to graft tissue source (2 HLA haplotype-identical sibling vs all others) and topical steroid use at baseline (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral beclomethasone dipropionate 4 times daily on days 1-50. Patients also receive oral prednisone (or methylprednisolone IV) twice daily on days 1-10 with a rapid taper on days 11-17 followed by low-dose prednisone on days 18-80.
  • Arm II: Patients receive oral placebo 4 times daily on days 1-50. Patients also receive prednisone (or methylprednisolone) as in arm I.

In both arms, treatment continues in the absence of poorly controlled GVHD at day 10 or unacceptable toxicity.

Patients are followed at days 51, 60, and 80 and then at 200 days post-transplantation.

PROJECTED ACCRUAL: A total of 130 patients (65 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Grade II Graft vs. Host Disease With Gastrointestinal Symptoms
Study Start Date : April 2002
Actual Study Completion Date : January 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed graft-vs-host disease (GVHD) with gastrointestinal symptoms

    • Endoscopic evidence of grade II intestinal GVHD without another plausible etiology
    • Confirmed by biopsy of colon, stomach, small intestine, esophagus, or skin within 72 hours prior to study entry
  • At least 10 days post allogeneic hematopoietic stem cell transplantation
  • Received prior anti-candidal prophylaxis of the oropharynx with an effective drug
  • Confirmed absence of intestinal infection within the past 7 days
  • No liver GVHD with bilirubin greater than 3 mg/dL
  • No skin GVHD other than a slowly evolving rash that involves no more than 50% of the body surface
  • No more than 1,000 mL/day of diarrhea on any 1 day within the past 3 days



  • Not specified

Performance status

  • Not specified

Life expectancy

  • At least 3 months


  • Not specified


  • See Disease Characteristics


  • Not specified


  • HIV negative
  • Able to swallow tablets
  • No multi-organ failure
  • No sepsis syndrome
  • No other condition with high mortality
  • No infection of the mouth or esophagus with a fungal organism
  • No persistent vomiting of oral intake
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • See Disease Characteristics
  • At least 30 days since prior biologic agents


  • Not specified

Endocrine therapy

  • At least 30 days since prior systemic (oral or parenteral) prescription corticosteroids administered for prophylaxis or treatment of GVHD or another inflammatory disease process
  • Concurrent dexamethasone as an antiemetic or to lessen side effects during medication or blood product administration allowed


  • Not specified


  • See Disease Characteristics


  • No prior beclomethasone dipropionate
  • At least 30 days since prior investigational drugs or devices
  • Concurrent immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus, methotrexate, or mycophenolate mofetil) allowed for GVHD prophylaxis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00043147

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Miguel-Angel Perales, MD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00043147    
Other Study ID Numbers: ENTERON-00-02
CDR0000256305 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: December 2004
Keywords provided by National Cancer Institute (NCI):
graft versus host disease
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Asthmatic Agents
Respiratory System Agents