A Multicenter, Prospective Trial to Evaluate the Role of NK Cell KIR Epitope Mismatch on Mortality and Disease Relapse in T-Cell Depleted Hematopoietic Stem Cell Transplantation From HLA-C Mismatched, Unrelated Donors for Myeloid Malignancies
- Determine the incidence of disease-free survival at 1 year in patients with acute or
chronic myeloid leukemias undergoing T-cell-depleted hematopoietic stem cell
transplantation from HLA-C mismatched, unrelated donors.
- Determine the incidence of disease relapse at 1 year in patients treated with this
- Determine the incidence and severity of acute graft-vs-host disease (GVHD) at 100 days
and chronic GVHD at 1 year in these patients.
- Determine the incidence of graft failure at day 100.
- Determine the transplant-related mortality of these patients at 1 year.
- Determine the overall survival of these patients at 1 year.
OUTLINE: This is a prospective, multicenter study. Patients are stratified according to
killer-cell immunoglobulin-like receptors (KIR) epitope mismatch (yes [experimental] vs no
- Myeloablative preparative regimen: Patients undergo total body irradiation twice daily
on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and
-7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte
globulin IV over 4-6 hours on days -5 to -2.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo
filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC
transplantation on day 0.
After completion of study treatment, patients are followed periodically for at least 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Disease-free Survival
Number of patients alive and without disease at 1 year after transplant.
Daniel J. Weisdorf, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Midwest Children's Cancer Center at Children's Hospital of Wisconsin||Milwaukee, Wisconsin 53226|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Moffitt Cancer Center||Tampa, Florida 33612|