Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002456
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
1999-11-01
Brief Title:
Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2011-11
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 Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells Sometimes the transplanted cells can make an immune response against normal tissues Methotrexate and cyclosporine may prevent this from happening
PURPOSE Phase III trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease
PURPOSE Phase III trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease
Detailed Description:
OBJECTIVES I Determine the efficacy of a combination of methotrexate and cyclosporine administered after grafting to prevent the development of acute graft versus host disease GVHD in patients undergoing allogeneic bone marrow transplantation
OUTLINE Patients receive methotrexate IV on days 136 and 11 Patients also receive cyclosporine IV twice a day until the patient is eating then it is administered orally twice a day Cyclosporine begins on day -1 and continues until day 180 The dose is reduced beginning on day 50
PROJECTED ACCRUAL Accrual will continue until further notice
OUTLINE Patients receive methotrexate IV on days 136 and 11 Patients also receive cyclosporine IV twice a day until the patient is eating then it is administered orally twice a day Cyclosporine begins on day -1 and continues until day 180 The dose is reduced beginning on day 50
PROJECTED ACCRUAL Accrual will continue until further notice
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 |
|---|---|---|---|
| CDR0000074146 | REGISTRY | PDQ | None |
| FHCRC-26701 | None | None | None |
| FHCRC-26700 | None | None | None |
| NCI-V86-0145 | None | None | None |