KIR Mismatched Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies
Donors will undergo G-CSF mobilization of peripheral blood stem cells (PBSC) prior to
undergoing two apheresis collections of hematopoietic progenitor cells (HPC,A) and one
apheresis collection of therapeutic cell product of purified natural killer cells (TC-NK).
The HPC products will be T-cell depleted (TCD) using the investigational CliniMACS device.
CD34+ enrichment and CD45RA depletion will be utilized on sequential HPC grafts.
Participants will undergo a preparative regimen of total lymphoid irradiation, fludarabine,
cyclophosphamide, granulocyte colony stimulating factor (G-CSF), thiotepa, and melphalan.
This is followed by infusions of donor cells that have been prepared using the CliniMACS
system: HPC,A (CD34+ selected), HPC,A (CD45RA depleted), and TC-NK.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of successful engraftment
Neutrophil engraftment will be determined using the parameters put forth by the Center for International Blood and Marrow Registry. Assessments will be made upon review of daily complete blood count and serial chimerism studies. Successful engraftment for the purposes of this objective will be patients who do not experience graft failure.
42 days post engraftment
Brandon M. Triplett, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|