Acute Myelogenous Leukemia Clinical Trial
Official title:
KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor
Verified date | March 2021 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 506 |
Est. completion date | April 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: 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). |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Chicago Medical Center Cancer Center | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Baylor Sammons Cancer Center | Dallas | Texas |
United States | Colorado Blood Cancer Institute | Denver | Colorado |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | M.D. Anderson Cancer Center | Houston | Texas |
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 | New York Presbyterian Weill Cornell Medical Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Methodist Healthcare System of San Antonio | San Antonio | Texas |
United States | Mayo Clinic - Scottsdale | Scottsdale | Arizona |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 Years | |
Secondary | Incidence of Relapse-Free Survival | 2 Years | ||
Secondary | Overall Survival | 2 Years | ||
Secondary | Incidence of Engraftment | 2 Years | ||
Secondary | Incidence of Graft Versus Host Disease | 2 Years | ||
Secondary | Incidence of Transplant Related Mortality | Number of patients who died within 2 years of transplant. | 2 Years |
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