Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease
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.
|Graft Versus Host Disease||Drug: beclomethasone dipropionate Drug: methylprednisolone Drug: prednisone||Phase 3|
|Study Design:||Allocation: Randomized
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|
|Study Completion Date:||January 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043147
|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|
|Study Chair:||Miguel-Angel Perales, MD||Memorial Sloan Kettering Cancer Center|