Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-02 @ 6:59 PM
Study NCT ID:
NCT00513318
Status:
TERMINATED
Last Update Posted:
2013-08-02
First Post:
2007-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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:
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?: