HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
Secondary objectives for this study include the following:
- To estimate the incidence of three transplant-related adverse outcomes (i.e.,
regimen-related mortality, engraftment failure, and fatal acute GVHD) in the first 100
days after transplantation.
- To estimate the incidence of chronic graft-versus-host disease.
- To evaluate those factors that affect one-year survival.
- To assess the kinetics of lymphohematopoietic reconstitution.
- To assess the frequency and clinical relevance of minimal residual disease (MRD) before
and after transplantation.
- To evaluate the incidence of and risk factors for long-term neurocognitive deficit and
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a non-TBI based preparative regimen and T-lymphocyte depleted graft with a subsequent infusion of donor NK cells.
Wing H. Leung, M.D., PhD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|