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OpenTrials
Completed

NCT Number: NCT01288222

Selecting a Favorable KIR Donor in Unrelated HCT for AML

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.

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Key information

Conditions

Acute Myelogenous Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

KIR genotype

Other

KIR genotype data from unrelated donor are collected

Primary outcomes

  1. Incidence of Relapse

    Time frame: 2 Years

    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.

Secondary outcomes

  1. Incidence of Relapse-Free Survival

    Time frame: 2 Years

  2. Overall Survival

    Time frame: 2 Years

  3. Incidence of Engraftment

    Time frame: 2 Years

  4. Incidence of Graft Versus Host Disease

    Time frame: 2 Years

  5. Incidence of Transplant Related Mortality

    Time frame: 2 Years

    Number of patients who died within 2 years of transplant.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2011
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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