Cancer Clinical Trial
Official title:
A Myeloablative Conditioning Regimen Consisting of Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients With Hematological Malignancy.
In this study two cord blood collections will be used to increase the number of cord blood
cells you will receive on transplant day. We call this a "double unit" cord blood
transplant. A previous study suggests double unit cord blood transplant may have a better
result. The main purpose of this study is to find out how good a cord blood transplant using
two cord blood collections from two different babies is at curing you of your cancer. Double
unit cord blood transplants are now being studied as a way to increase the number of cord
blood cells given to bigger children and adult patients.
Based on studies that have already been done double unit cord blood transplant appears to be
safer than if only one cord blood unit is used. However, double unit cord blood transplant
is a fairly new form of treatment.
This is a single arm phase 2 study to obtain a preliminary estimate of efficacy of myeloablative double unit umbilical cord blood transplantation (UCBT) as measured by overall and disease-free survival at 1 year post transplantation. The UCB graft will consist of two (or double) units from two unrelated newborn donors. Patients with hematopoietic malignancy at high-risk for relapse or with advanced disease will receive myeloablative conditioning with cyclophosphamide (Cy),low dose fludarabine (Flu) and total body irradiation (TBI) with post transplantation cyclosporine (CSA) and mycophenolate mofetil (MMF) for GVHD prophylaxis. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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