Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089141
Status:
TERMINATED
Last Update Posted:
2013-05-03
First Post:
2004-08-04
Brief Title:
Mycophenolate Mofetil MMF for Treatment of Chronic Graft-versus-host Disease GVHD
Sponsor:
Martin Paul
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Randomized Study to Evaluate The Efficacy of Mycophenolate Mofetil Added to The Systemic Immunosuppressive Regimen First Used For Treatment of Chronic Graft-Versus-Host Disease
Status:
TERMINATED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low probability of positive outcome
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Mycophenolate mofetil added to immunosuppressive treatment regimens may be effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell transplantation It is not yet known whether immunosuppressive treatment regimens are more effective with or without mycophenolate mofetil in treating chronic graft-versus-host disease
PURPOSE This randomized phase III trial is studying whether the addition of mycophenolate mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly diagnosed chronic graft-versus-host disease
PURPOSE This randomized phase III trial is studying whether the addition of mycophenolate mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly diagnosed chronic graft-versus-host disease
Detailed Description:
OBJECTIVES
Compare the efficacy of immunosuppressive treatment regimens with vs without mycophenolate mofetil in patients with newly diagnosed chronic graft-vs-host disease
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled prospective multicenter study Patients are stratified according to organ involvement of chronic graft-versus-host disease GVHD single organ vs multiple organs and transplant center Patients are randomized to 1 of 2 treatment arms
All patients receive usual therapy for chronic GVHD comprising oral prednisone twice daily and oral cyclosporine oral tacrolimus or oral sirolimus twice daily until 2 weeks after the first evidence of improvement of symptoms of chronic GVHD
Arm I Patients receive oral mycophenolate mofetil twice daily
Arm II Patients receive oral placebo twice daily In both arms administration of the study drug continues for 3 months after completion of prednisone and cyclosporine tacrolimus or sirolimus in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 3 months
Patients are followed every 3 months for 3-5 years
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within 3 years
Compare the efficacy of immunosuppressive treatment regimens with vs without mycophenolate mofetil in patients with newly diagnosed chronic graft-vs-host disease
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled prospective multicenter study Patients are stratified according to organ involvement of chronic graft-versus-host disease GVHD single organ vs multiple organs and transplant center Patients are randomized to 1 of 2 treatment arms
All patients receive usual therapy for chronic GVHD comprising oral prednisone twice daily and oral cyclosporine oral tacrolimus or oral sirolimus twice daily until 2 weeks after the first evidence of improvement of symptoms of chronic GVHD
Arm I Patients receive oral mycophenolate mofetil twice daily
Arm II Patients receive oral placebo twice daily In both arms administration of the study drug continues for 3 months after completion of prednisone and cyclosporine tacrolimus or sirolimus in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 3 months
Patients are followed every 3 months for 3-5 years
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-169700 | None | None | None |
| UMN-2004UC007 | None | None | None |
| ROCHE-FHCRC-169700 | None | None | None |
| CDR0000378054 | REGISTRY | PDQ | None |