Donors with favorable KIR B haplotype gene content have yielded reduced relapse risk and improved leukemia free survival (LFS) in retrospective analyses of unrelated donor (URD) hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML). Specifically, donors with more KIR B gene content and those who are homozygous for the centromeric (Cen) B haplotype genes (as opposed to the telomeric (Tel) genes confer the most protective effect. This study proposes to prospectively test and validate the utility and effectiveness of further informing URD identification and selection by KIR genotyping as a supplement to HLA matching and the other variables known or suspected to indicate the best URD for a patient. Hypotheses: 1. Favorable KIR donors will improve protection against relapse and improve leukemia free survival (LFS) after URD HCT for AML. 2. Directed study procedures for rapid KIR genotyping and reporting to searching Transplant Centers (TC) can inform donor search and selection without delay in donor availability for HCT.
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
506
KIR genotype data from unrelated donor are collected
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center Cancer Center
Chicago, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Kansas University Cancer Center
Kansas City, Kansas, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
...and 9 more locations
Incidence of Relapse
To measure the impact of donor selection for KIR genotype in allogeneic URD HCT for AML on cumulative incidence of relapse. We will determine a quantitative estimate of the likelihood of better KIR donors identified with routine, non-directed donor selection along with KIR genotyping data. The observed incidence of success in a better KIR donor identified within 8 weeks will be compared to the original donor genotype expected frequencies identified in our retrospective genotyping of 1086 donors selected for AML transplants.
Time frame: 2 Years
Incidence of Relapse-Free Survival
Time frame: 2 Years
Overall Survival
Time frame: 2 Years
Incidence of Engraftment
Time frame: 2 Years
Incidence of Graft Versus Host Disease
Time frame: 2 Years
Incidence of Transplant Related Mortality
Number of patients who died within 2 years of transplant.
Time frame: 2 Years
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