Umbilical Cord Blood Transplantation In Patients With Hematologic Malignancies Using A Myeloablative Preparative Regimen
The primary objectives is to estimate the event-free survival (EFS) at one-year
post-transplant for research participants with high-risk hematologic malignancies undergoing
hematopoietic cell transplantation (HCT) using single unit umbilical cord blood (UCB).
Secondary objectives are:
- Describe the clinical outcome of patients undergoing a double unit UCBT.
- Estimate the incidence and severity of acute and chronic graft versus host disease
(GVHD) of patients enrolled in the research arm.
- Estimate the incidence and time to neutrophil and platelet engraftment among patients
enrolled in the research arm.
- Estimate the incidence of transplant related mortality (TRM) and transplant related
morbidity in the first 100 days after transplantation among patients enrolled in the
Exploratory Objectives are:
- Assess the relationship between pre-transplant minimal residual disease (MRD) with
- Record immune reconstitution parameters, including chimerism analysis, quantitative
lymphocyte subsets, T cell receptor excision circle (TREC) and spectratyping.
Immunophenotyping and functional assays of T, B and NK cells and lymphocytes will also
- Evaluate the determinants of engraftment.
- Characterize the pharmacokinetics of mycophenolate mofetil (MMF).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event Free survival at one- year post transplant will be estimated for research participants by using single unit umbilical cord blood
Specifically, event free survival is calculated as the difference between date of HCT and min (last follow-up date, date of relapse, date of graft failure, date of death due to any cause, 1 year post-transplant).
Mari H Dallas, MD
St. Jude Children's Research Hospital
United States: Institutional Review Board
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|