Selecting a Favorable KIR Donor in Unrelated HCT for AML
Conditions
Acute Myelogenous Leukemia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
acute myelogenous leukemia, hematopoietic cell transplantation, unrelated donor
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: KIR genotype Type: Biological
Name: Unrelated donor transplant Type: Biological
Overall Status
Recruiting
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.
Detailed Description
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
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).
Locations
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Status: Recruiting
Contact: James Slack, MD - slack.james@mayo.edu
Colorado Blood Cancer Institute
Denver, Colorado, United States
Status: Recruiting
Contact: Mark Bruvand, MD - 720-754-4800 - mark.brunvand@healthonecares.com
Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Edmund K. Wallter, MD - 404-727-4995 - ewaller@emory.edu
University of Chicago Medical Center Cancer Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Koen van Besien, MD - 773-702-6149 - kvbesien@medicine.bsd.uchicago.edu
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Sherif Farag, MD - 317-274-0843 - ssfarag@iupui.edu
Kansas University Cancer Center
Kansas City, Kansas, United States
Status: Recruiting
Contact: Joseph McGuirk, MD - 913-588-6029 - jmcguirk@kumc.edu
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Daniel Weisdorf, M.D. - 612-624-0123 - weisd001@umn.edu
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Status: Not yet recruiting
Contact: Mark Litzow, MD - 507-284-2511 - litzow.mark@mayo.edu
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Contact: Peter Westervelt, MD - 314-454-8323 - pwesterv@im.wustl.edu
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Not yet recruiting
Contact: Alfred P. Gillio, MD - 201-996-5437 - agillio@humed.com
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Contact: Maureen Ross, MD - 716-845-2300 - maureen.ross@roswellpark.org
New York Presbyterian Weill Cornell Medical Center
New York City, New York, United States
Status: Recruiting
Contact: Tsiporah Shore, MD - 212-746-2646 - tbs2001@med.cornell.edu
Cleveland Clinic
Cleveland, Ohio, United States
Status: Recruiting
Contact: Ronald Sobecks, MD - 216-445-4626 - sobeckr@ccf.org
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Steven M. Devine, MD - 614-293-6794 - steven.devine@osumc.edu
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Not yet recruiting
Contact: David Porter, MD - 215-662-5858 - david.porter@uphs.upenn.edu
Baylor Sammons Cancer Center
Dallas, Texas, United States
Status: Not yet recruiting
Contact: Edward Agura, MD - edward.agura@baylorhealth.edu
M.D. Anderson Cancer Center
Houston, Texas, United States
Status: Not yet recruiting
Contact: Richard Champlin, MD - rchampli@mdanderson.org
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Paul Shaughnessy, MD - 210-575-8500 - paul.shaughnessy@MHShealth.com
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Status: Recruiting
Contact: Ann E Woolfrey, MD - 206-667-4324 - awoolfre@fhcrc.org
Start Date
June 2011
Completion Date
July 2016
Sponsors
Masonic Cancer Center, University of Minnesota
Source
Masonic Cancer Center, University of Minnesota
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page