Selecting a Favorable KIR Donor in Unrelated HCT for AML

University of Minnesota (UMN)

Status: Completed

Conditions: Acute Myelogenous Leukemia

Treatments: Other: KIR genotype

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01288222

MT2010-06 (Other Identifier)

2010LSUC043

P01CA111412 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 506 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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506 participants in 1 patient group

Unrelated Donor Transplant Patients

Experimental group

Description:

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

Treatment:

Other: KIR genotype