Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-01 @ 12:31 AM
Study NCT ID:
NCT01274195
Status:
UNKNOWN
Last Update Posted:
2013-11-19
First Post:
2011-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
Status:
UNKNOWN
Status Verified Date:
2013-11
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:
In this study we plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.
Detailed Description:
Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.
Study Oversight
Has Oversight DMC:
True
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?: