Trials / Terminated

TerminatedNCT00513318

Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies

Status: Terminated
Phase: —
Study type: Observational
Enrollment: 15 (estimated)

Sponsor: University of California, San Francisco · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

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.

Conditions

Timeline

Start date: 2004-08-01
Primary completion: 2009-06-01
Completion: 2009-06-01
First posted: 2007-08-08
Last updated: 2013-08-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00513318. Inclusion in this directory is not an endorsement.