Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004323
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-04
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 Evaluate the efficacy of related HLA-identical bone marrow transplantation following cyclophosphamide CTX and antithymocyte globulin in patients with aplastic anemia
II Evaluate the efficacy of related HLA-nonidentical bone marrow transplantation following CTX and total-body irradiationtotal-lymphoid irradiation in patients with aplastic anemia
II Evaluate the efficacy of related HLA-nonidentical bone marrow transplantation following CTX and total-body irradiationtotal-lymphoid irradiation in patients with aplastic anemia
Detailed Description:
PROTOCOL OUTLINE Patients with HLA-identical donors receive cyclophosphamidemesna antithymocyte globulin ATG and methylprednisolone MePRDL followed by allogeneic marrow transplantation
Patients with HLA-nonidentical 56 or 46 donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue In addition these patients are treated with total-body irradiation total-lymphoid irradiation and methotrexate
All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis
Patients with HLA-nonidentical 56 or 46 donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue In addition these patients are treated with total-body irradiation total-lymphoid irradiation and methotrexate
All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis
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 |
|---|---|---|---|
| UCLA-94020602 | None | None | None |