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
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the incidence of disease relapse at 1 year in patients treated with this
regimen.
- 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
[control]).
- 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.
Interventional
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.
1 Year
No
Daniel J. Weisdorf, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
2004UC035
NCT00392782
July 2005
May 2011
Name | Location |
---|---|
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 |