Selecting a Favorable KIR Donor in Unrelated HCT for AML

NCT01288222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2021-03-11

No results posted yet for this study

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.

Conditions

  • Acute Myelogenous Leukemia

Interventions

OTHER

KIR genotype

KIR genotype data from unrelated donor are collected

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Daniel Weisdorf, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288222 on ClinicalTrials.gov