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Selecting a Favorable KIR Donor in Unrelated HCT for AML

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01288222
First received: February 1, 2011
Last updated: December 7, 2016
Last verified: December 2016
  Purpose

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.

Condition Intervention
Acute Myelogenous Leukemia
Biological: KIR genotype
Biological: Unrelated donor transplant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Incidence of Relapse [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Incidence of Relapse-Free Survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Incidence of Engraftment [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Incidence of Graft Versus Host Disease [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Incidence of Transplant Related Mortality [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    Number of patients who died within 2 years of transplant.


Enrollment: 506
Study Start Date: June 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unrelated Donor Transplant Patients
Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant.
Biological: KIR genotype
KIR genotype from unrelated donor.
Biological: Unrelated donor transplant
hematopoietic cell transplant performed per each center's guidelines
Other Name: bone marrow transplant

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288222

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01288222     History of Changes
Other Study ID Numbers: 2010LSUC043  MT2010-06  P01CA111412 
Study First Received: February 1, 2011
Last Updated: December 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
acute myelogenous leukemia
hematopoietic cell transplantation
unrelated donor

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on December 09, 2016