Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-23 @ 6:50 PM
Study NCT ID:
NCT00514722
Status:
None
Last Update Posted:
2013-08-14 00:00:00
First Post:
2007-08-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies
Sponsor:
None
Organization:
Study Overview
Official Title:
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies
Status:
None
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study intends to demonstrate an engraftment rate of \>80% at day 100 post-transplantation and a transplant related mortality rate of \< or equal to 50%. A TRM of \>50% will be considered unacceptable. The present research will also:
* Evaluate the toxicity of busulfan, fludarabine, and etoposide as preparative therapy prior to umbilical cord blood cell transplantation.
* Evaluate neutrophil and platelet recovery following UCB transplantation.
* Evaluate lineage-specific chimerism following transplantation and to assess the contribution of each individual CB unit to post-transplantation hematopoiesis.
* Evaluate event free and overall survival.
* Evaluate the incidence, severity and timing of acute and chronic GVHD following UCB transplantation.
* Evaluate the toxicity of busulfan, fludarabine, and etoposide as preparative therapy prior to umbilical cord blood cell transplantation.
* Evaluate neutrophil and platelet recovery following UCB transplantation.
* Evaluate lineage-specific chimerism following transplantation and to assess the contribution of each individual CB unit to post-transplantation hematopoiesis.
* Evaluate event free and overall survival.
* Evaluate the incidence, severity and timing of acute and chronic GVHD following UCB transplantation.
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?: