Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005898
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-06-02
Brief Title:
Phase III Study of Total Body Irradiation Cyclophosphamide and Fludarabine Followed by Alternate Donor Hematopoietic Cell Transplantation in Patients With Fanconis Anemia
Sponsor:
University of Minnesota
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
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 Determine the probability of engraftment with total body irradiation cyclophosphamide fludarabine and anti-thymocyte globulin followed by HLA nongenotypically identical donor T-cell depleted hematopoietic cell transplantation in patients with Fanconis anemia
II Determine the incidence of acute and chronic graft-versus-host disease in these patients after undergoing this treatment regimen
III Determine the one-year survival rate in these patients after undergoing this treatment regimen
IV Determine the toxicity of this treatment regimen in these patients V Determine the incidence of relapse in patients with myelodysplastic syndrome or acute myeloid leukemia after undergoing this treatment regimen
II Determine the incidence of acute and chronic graft-versus-host disease in these patients after undergoing this treatment regimen
III Determine the one-year survival rate in these patients after undergoing this treatment regimen
IV Determine the toxicity of this treatment regimen in these patients V Determine the incidence of relapse in patients with myelodysplastic syndrome or acute myeloid leukemia after undergoing this treatment regimen
Detailed Description:
PROTOCOL OUTLINE Donor bone marrow peripheral blood or umbilical cord blood is processed to harvest CD34 cells
Patients receive preparative cytoreductive therapy comprising total body irradiation on day -6 cyclophosphamide IV over 2 hours on days -5 to -2 fludarabine IV over 30 minutes on days -5 to -2 methylprednisone IV on days -5 to 24 anti-thymocyte globulin IV over 4-6 hours on days -5 to -1 cyclosporine IV over 2 hours every 12 hours every 8 hours for patients less than 40 kg in weight on days -3 to 180 and then tapering in the absence of graft-versus-host disease hematopoietic cell transplantation on day 0 and filgrastim G-CSF IV starting on day 1 and continuing until blood counts recover
Patients are followed at days 60 90 and 180 and then annually for 3 years
Patients receive preparative cytoreductive therapy comprising total body irradiation on day -6 cyclophosphamide IV over 2 hours on days -5 to -2 fludarabine IV over 30 minutes on days -5 to -2 methylprednisone IV on days -5 to 24 anti-thymocyte globulin IV over 4-6 hours on days -5 to -1 cyclosporine IV over 2 hours every 12 hours every 8 hours for patients less than 40 kg in weight on days -3 to 180 and then tapering in the absence of graft-versus-host disease hematopoietic cell transplantation on day 0 and filgrastim G-CSF IV starting on day 1 and continuing until blood counts recover
Patients are followed at days 60 90 and 180 and then annually for 3 years
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 |
|---|---|---|---|
| UMN-MT9905 | None | None | None |
| UMN-MT-1999-05 | None | None | None |