Selecting a Favorable KIR Donor in Unrelated HCT for AML

NCT ID: NCT01288222

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2020-04-30

Brief Summary

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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

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

Conditions

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Acute Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unrelated Donor Transplant Patients

Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant.

Group Type EXPERIMENTAL

KIR genotype

Intervention Type OTHER

KIR genotype data from unrelated donor are collected

Interventions

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KIR genotype

KIR genotype data from unrelated donor are collected

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Weisdorf, M.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

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Mayo Clinic - Scottsdale

Scottsdale, Arizona, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University of Chicago Medical Center Cancer Center

Chicago, Illinois, United States

Site Status

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Kansas University Cancer Center

Kansas City, Kansas, United States

Site Status

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

New York Presbyterian Weill Cornell Medical Center

New York, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Baylor Sammons Cancer Center

Dallas, Texas, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Methodist Healthcare System of San Antonio

San Antonio, Texas, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Cooley S, Weisdorf DJ, Guethlein LA, Klein JP, Wang T, Marsh SG, Spellman S, Haagenson MD, Saeturn K, Ladner M, Trachtenberg E, Parham P, Miller JS. Donor killer cell Ig-like receptor B haplotypes, recipient HLA-C1, and HLA-C mismatch enhance the clinical benefit of unrelated transplantation for acute myelogenous leukemia. J Immunol. 2014 May 15;192(10):4592-600. doi: 10.4049/jimmunol.1302517. Epub 2014 Apr 18.

Reference Type DERIVED
PMID: 24748496 (View on PubMed)

Other Identifiers

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MT2010-06

Identifier Type: OTHER

Identifier Source: secondary_id

P01CA111412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010LSUC043

Identifier Type: -

Identifier Source: org_study_id

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