Ignite Creation Date:
2024-05-05 @ 9:25 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00882323
Status:
UNKNOWN
Last Update Posted:
2012-03-26
First Post:
2009-04-15
Brief Title:
Reduced Toxicity Fludarabine Flu Cyclophosphamide CPM Rabbit Antithymocyte Globulin rATG Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia SAA
Sponsor:
The Korean Society of Pediatric Hematology Oncology
Organization:
The Korean Society of Pediatric Hematology Oncology
Study Overview
Official Title:
Reduced Toxicity Fludarabine Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
RECRUITING
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:
Anti-thymocyte globulin ATG has been used in severe aplastic anemia as a part of the conditioning regimen Among the many kinds of ATG preparations thymoglobulin had been found to be more effective in preventing graft versus host disease GVHD and rejection of organ transplants As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for transplantation from alternative donors in SAA thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in unrelated donor transplantation Our previous phase II study of fludarabine cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment 100 and survival rate 74 But grade IIIIV toxicities occurred in 25 of patients and all events were treatment related mortalities As cyclophosphamide is more toxic agent than fludarabine we plan a new phase II study re reduced toxicity fludarabine cyclophosphamide plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe aplastic anemia by reducing dosage of cyclophosphamide and increasing dosage of fludarabine
Detailed Description:
None
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