Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343785
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2006-06-22
Brief Title:
Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia Effect of Marrow Cell Dose on Chronic Graft-vs-Host Disease A Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This clinical trial is studying how well giving cyclophosphamide together with anti-thymocyte globulin followed by methotrexate and cyclosporine works in preventing chronic graft-vs-host disease GVHD in patients with severe aplastic anemia undergoing donor bone marrow transplant Giving low doses of chemotherapy such as cyclophosphamide before a donor bone marrow transplant helps stop the growth of abnormal cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system and help destroy any remaining abnormal cells Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving anti-thymocyte globulin before and methotrexate and cyclosporine after transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 20-25 x 108 nucleated cellskg
SECONDARY OBJECTIVES
I Engraftment and overall survival
OUTLINE
CONDITIONING REGIMEN Patients receive cyclophosphamide intravenously IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2
TRANSPLANTATION Patients undergo allogeneic bone marrow transplantation on day 0
GVHD PROPHYLAXIS Patients receive methotrexate IV on days 1 3 6 and 11 and cyclosporine IV over 1 hour or orally PO twice daily on days -1 to 50 followed by a taper until 6 months after grafting
After completion of study treatment patients are followed up at on day 180 1 year 15 years 2 years 3 years and yearly thereafter
I Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 20-25 x 108 nucleated cellskg
SECONDARY OBJECTIVES
I Engraftment and overall survival
OUTLINE
CONDITIONING REGIMEN Patients receive cyclophosphamide intravenously IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2
TRANSPLANTATION Patients undergo allogeneic bone marrow transplantation on day 0
GVHD PROPHYLAXIS Patients receive methotrexate IV on days 1 3 6 and 11 and cyclosporine IV over 1 hour or orally PO twice daily on days -1 to 50 followed by a taper until 6 months after grafting
After completion of study treatment patients are followed up at on day 180 1 year 15 years 2 years 3 years and yearly thereafter
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 |
|---|---|---|---|
| P01HL036444 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01HL036444 |
| NCI-2010-01781 | REGISTRY | None | None |