Acute Myeloid Leukemia Clinical Trial

Selecting a Favorable KIR Donor in Unrelated HCT for AML

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:

Favorable KIR donors will improve protection against relapse and improve leukemia free survival (LFS) after URD HCT for AML.
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.

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Full Description

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

View Eligibility Criteria

Eligibility Criteria

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).

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

506

Study ID:

NCT01288222

Recruitment Status:

Completed

Sponsor:

Masonic Cancer Center, University of Minnesota

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There are 19 Locations for this study

See Locations Near You

Mayo Clinic - Scottsdale
Scottsdale Arizona, 85259, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Emory University
Atlanta Georgia, 30322, United States
University of Chicago Medical Center Cancer Center
Chicago Illinois, 60637, United States
Indiana University Simon Cancer Center
Indianapolis Indiana, 46202, United States
Kansas University Cancer Center
Kansas City Kansas, 66160, United States
Masonic Cancer Center, University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
New York Presbyterian Weill Cornell Medical Center
New York New York, 10021, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Methodist Healthcare System of San Antonio
San Antonio Texas, 78229, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

506

Study ID:

NCT01288222

Recruitment Status:

Completed

Sponsor:


Masonic Cancer Center, University of Minnesota

How clear is this clinincal trial information?

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