Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00513318
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.
Study:
NCT00513318
Study Brief:
Protocol Section:
NCT00513318