Clinical Trials Directory

Trials / Terminated

TerminatedNCT00514722

Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
18 Years – 55 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 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.

Conditions

Interventions

TypeNameDescription
OTHERumbilical cord stem cellsumbilical cord stem cell allogeneic transplantation

Timeline

Start date
2002-10-01
Primary completion
2009-03-01
Completion
2009-03-01
First posted
2007-08-10
Last updated
2013-08-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00514722. Inclusion in this directory is not an endorsement.