- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00043147
Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Not specified
Life expectancy
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- See Disease Characteristics
Renal
- Not specified
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 30 days since prior biologic agents
Chemotherapy
- 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
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Miguel-Angel Perales, MD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Graft vs Host Disease
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Prednisone
- Beclomethasone
Other Study ID Numbers
- ENTERON-00-02
- MSKCC-01149
- CDR0000256305 (Registry Identifier: PDQ (Physician Data Query))
- NCI-G02-2098
- RPCI-DS-01-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Graft Versus Host Disease
-
University of LiegeTerminatedChronic Graft-Versus-Host Disease | Acute Graft-Versus-Host Disease | Steroid Refractory Graft-Versus-Host DiseaseBelgium
-
Jazz PharmaceuticalsCompletedAcute-graft-versus-host Disease | Graft-versus-host DiseaseUnited States, Belgium, United Kingdom, Greece, Germany, Spain, France, Italy, Austria, Canada, Bulgaria, Croatia, Poland, Portugal
-
Mesoblast, Inc.Quintiles, Inc.CompletedGrade B Acute Graft Versus Host Disease | Grade C Acute Graft Versus Host Disease | Grade D Acute Graft Versus Host DiseaseUnited States
-
Grupo Espanol de trasplantes hematopoyeticos y...CompletedChronic Graft-Versus-Host DiseaseSpain
-
National Cancer Institute (NCI)TerminatedGraft vs Host Disease | Graft-Versus-Host Disease | Chronic Graft vs. Host DiseaseUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNovartisCompletedGraft-Versus-Host DiseaseUnited States
-
M.D. Anderson Cancer CenterCompleted
-
Fundación Pública Andaluza para la gestión de la...Instituto de Salud Carlos IIIActive, not recruitingGraft-versus-host DiseaseSpain
-
National Heart, Lung, and Blood Institute (NHLBI)TerminatedGraft-Versus-Host DiseaseUnited States
-
MallinckrodtCompletedGraft-versus-Host DiseaseUnited States, Australia, France, Italy, Austria, Germany, Portugal, Slovakia, Spain, Switzerland, Turkey, United Kingdom
Clinical Trials on prednisone
-
Merck KGaA, Darmstadt, GermanyCompleted
-
University of South FloridaNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Arthritis... and other collaboratorsActive, not recruitingVasculitis | Granulomatosis With Polyangiitis | Wegener GranulomatosisUnited States
-
Rabin Medical CenterUnknown
-
University of Alabama at BirminghamNational Institute of Neurological Disorders and Stroke (NINDS)CompletedMyasthenia GravisThailand, Canada, Germany, Italy, Netherlands, Brazil, United States, Argentina, Australia, Chile, Japan, Mexico, Poland, Portugal, South Africa, Spain, Taiwan, United Kingdom
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Arthritis... and other collaboratorsActive, not recruitingGranulomatosis With PolyangiitisUnited States, Canada
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUnknown
-
Fundación Pública Andaluza para la Investigación...Sociedad Andaluza de Trasplantes de Organos y TejidosCompletedRenal Transplant Rejection | Other Complication of Kidney TransplantSpain
-
Prof. Tony hayek MDCompletedDiabetes | Atherosclerosis | DyslipidemiasIsrael
-
Health Science Center of Xi'an Jiaotong UniversityUnknownFocal Segmental GlomerulosclerosisChina
-
National Institute for Tuberculosis and Lung Diseases...SuspendedInterstitial Lung Disease | Lung Neoplasm MalignantPoland