Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043147
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2002-08-05
Brief Title:
Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-01-09 | Registry Identifier | PDQ Physician Data Query | None |
| MSKCC-01149 | None | None | None |
| CDR0000256305 | REGISTRY | None | None |
| NCI-G02-2098 | None | None | None |