Selecting a Favorable KIR Donor in Unrelated HCT for AML

Completed · Not applicable

Conditions studied: Acute Myelogenous Leukemia

In brief

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.

Key facts

Study ID

NCT01288222

Run by

Masonic Cancer Center, University of Minnesota

People needed

506

Starts

2011-06-01

Expected to finish

2020-04-01

Last updated by the study team

2021-03-11

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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
• Roswell Park Cancer Institute — Buffalo, New York, United States
• New York Presbyterian Weill Cornell Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, 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
• M.D. Anderson Cancer Center — Houston, Texas, United States
• Methodist Healthcare System of San Antonio — San Antonio, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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