Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004474
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Status:
COMPLETED
Status Verified Date:
2008-10
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:
OBJECTIVES
I Compare outcome including graft failure graft versus host disease and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen
I Compare outcome including graft failure graft versus host disease and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen
Detailed Description:
PROTOCOL OUTLINE This is a randomized multicenter study Patients are randomized to receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte globulin IV over 4 hours
All patients then receive bone marrow over 60-120 minutes on day 0 36 hours after the last dose of cyclophosphamide
Patients are followed at day 100 at 6 months and at 1 year posttransplant
All patients then receive bone marrow over 60-120 minutes on day 0 36 hours after the last dose of cyclophosphamide
Patients are followed at day 100 at 6 months and at 1 year posttransplant
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 |
|---|---|---|---|
| RPCI-RP-9804 | None | None | None |
| NCI-G98-1491 | None | None | None |
| IBMTR-1 | None | None | None |