Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514722
Status:
TERMINATED
Last Update Posted:
2013-08-14
First Post:
2007-08-08
Brief Title:
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies
Status:
TERMINATED
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 is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in adults with high-risk hematopoietic malignancies A novel myeloablative preparative regimen will be used One up to a maximum of three cord blood units will be administered to facilitate engraftment
Detailed Description:
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
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