A Reduced Intensity Conditioning Regimen With CD3-Depleted Hematopoietic Stem Cells to Improve Survival for Patients With Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation
This study will explore the following objectives:
1. To assess if the event-free survival at one-year post-transplant for research
participants with high-risk hematologic malignancies can be improved following HAPLO
hematopoietic stem cell transplant (HSCT) using a graft depleted of CD3+ cells ex vivo
and a reduced intensity-conditioning regimen.
1. To estimate the one-year overall survival (OS) and disease-free survival (DFS) for
research participants who receive this study treatment.
2. To estimate the cumulative incidence of relapse for research participants who receive
this study treatment.
3. To estimate the rate of overall grade III-IV acute GVHD, and the rate and severity of
chronic GVHD in research participants.
4. To estimate the incidence of non-hematologic regimen-related toxicity and
regimen-related mortality in the first 100 days post-transplant.
1. To explore the biologic significance of soluble interleukin-2 receptor and immunologic
state [quantitative lymphocyte studies, V beta spectratyping, T-cell receptor excision
circles (TREC) assay] to predict the development of acute and chronic GVHD in these
2. To measure the pharmacokinetics of Campath-1H in pediatric HAPLO HSCT recipients
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product.
one year post-transplant
Brandon Triplett, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|