Selecting a Favorable KIR Donor in Unrelated HCT for AML

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288222
• Other study ID #: 2010LSUC043
• Secondary ID: MT2010-06P01CA11
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: April 2020

Study information

• Verified date: March 2021
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• KIR genotype
KIR genotype data from unrelated donor are collected

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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