Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513318
Status:
TERMINATED
Last Update Posted:
2013-08-02
First Post:
2007-08-07
Brief Title:
Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment to justify keeping open
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 older adults or younger infirm patients with high-risk hematopoeitic malignancies A novel reduced-intensity preparative regimen for umbilical cord blood transplantation will be used One to a maximum of three cord blood units depending on cell count will be administered to facilitate engraftment Ten patients will be enrolled with an expected accrual rate of 3-4 patients per year and with a goal of completing accrual within 2-3 years
Detailed Description:
Primary Objective
To assess the feasibility of performing umbilical cord blood transplants in older adults or younger infirm patients using a reduced-intensity preparative regimen Feasibility of the procedure is defined as an engraftment rate of 80 at Day 180 post-transplantation and a transplant related mortality TRM of 50 at Day 100 A TRM of 50 will be considered unacceptable
Secondary objectives
To describe the time to neutrophil and platelet recovery following mini-UCB transplantation
To assess lineage-specific chimerism following transplantation and to describe the contribution of each individual CB unit to post-transplantation hematopoeisis
To describe disease-specific event-free and overall survival rates at 180 and 360 days
To describe the incidence severity and timing of acute and chronic GVHD following reduced-intensity UCB transplantation
To evaluate T-cell B-cell and NK cell recovery following reduced-intensity UCB transplantation
To assess the feasibility of performing umbilical cord blood transplants in older adults or younger infirm patients using a reduced-intensity preparative regimen Feasibility of the procedure is defined as an engraftment rate of 80 at Day 180 post-transplantation and a transplant related mortality TRM of 50 at Day 100 A TRM of 50 will be considered unacceptable
Secondary objectives
To describe the time to neutrophil and platelet recovery following mini-UCB transplantation
To assess lineage-specific chimerism following transplantation and to describe the contribution of each individual CB unit to post-transplantation hematopoeisis
To describe disease-specific event-free and overall survival rates at 180 and 360 days
To describe the incidence severity and timing of acute and chronic GVHD following reduced-intensity UCB transplantation
To evaluate T-cell B-cell and NK cell recovery following reduced-intensity 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