Selecting a Favorable KIR Donor in Unrelated HCT for AML
- Conditions
- Acute Myelogenous Leukemia
- Interventions
- Other: KIR genotype
- Registration Number
- NCT01288222
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Brief Summary
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.
- Detailed Description
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
- Patient with acute myeloid leukemia (AML) undergoing screening for potential URD HCT
- Potential URD undergoing screening to provide a HCT graft to a patient with acute myeloid leukemia (AML) at a participating institution
- Provides written consent
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor. In situations where the preferred (best > better > neutral) KIR donor is not selected in favor of a less favorable KIR genotype donor, the center will report one or more defined reasons (donor age; gender; parity; CMV status; ABO status; availability/logistics; other) for the choice (among equivalently HLA matched donors).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Unrelated Donor Transplant Patients KIR genotype Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant.
- Primary Outcome Measures
Name Time Method Incidence of Relapse 2 Years 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.
- Secondary Outcome Measures
Name Time Method Incidence of Graft Versus Host Disease 2 Years Overall Survival 2 Years Incidence of Engraftment 2 Years Incidence of Relapse-Free Survival 2 Years Incidence of Transplant Related Mortality 2 Years Number of patients who died within 2 years of transplant.
Trial Locations
- Locations (19)
Masonic Cancer Center, University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Mayo Clinic - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Kansas University Cancer Center
🇺🇸Kansas City, Kansas, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Indiana University Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Chicago Medical Center Cancer Center
🇺🇸Chicago, Illinois, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Sammons Cancer Center
🇺🇸Dallas, Texas, United States
New York Presbyterian Weill Cornell Medical Center
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Methodist Healthcare System of San Antonio
🇺🇸San Antonio, Texas, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States