Trial record 17 of 57 for:    Open Studies | "Unrelated Donors"

Selecting a Favorable KIR Donor in Unrelated HCT for AML

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Masonic Cancer Center, University of Minnesota
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01288222
First received: February 1, 2011
Last updated: May 15, 2014
Last verified: May 2014
  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.


Estimated Enrollment: 800
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

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

Contacts
Contact: Daniel Weisdorf, M.D. 612-624-0123 weisd001@umn.edu
Contact: Judy Witte, R.N. 612-626-0169 mirab001@umn.edu

Locations
United States, Arizona
Mayo Clinic - Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: James Slack, MD       slack.james@mayo.edu   
Principal Investigator: James Slack, MD         
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Mark Bruvand, MD    720-754-4800    mark.brunvand@healthonecares.com   
Principal Investigator: Mark Brunvand, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund K. Wallter, MD    404-727-4995    ewaller@emory.edu   
Contact: Amelia Langston, MD       amelia.langston@emoryhealthcare.org   
Principal Investigator: Edward K. Waller, MD         
United States, Illinois
University of Chicago Medical Center Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Koen van Besien, MD    773-702-6149    kvbesien@medicine.bsd.uchicago.edu   
Principal Investigator: Koen van Besien, MD         
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sherif Farag, MD    317-274-0843    ssfarag@iupui.edu   
Principal Investigator: Sherif Farag, MD         
United States, Kansas
Kansas University Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Joseph McGuirk, MD    913-588-6029    jmcguirk@kumc.edu   
Principal Investigator: Joseph McGuirk, MD         
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Daniel Weisdorf, M.D.    612-624-0123    weisd001@umn.edu   
Principal Investigator: Daniel Weisdorf, MD         
Mayo Clinic Cancer Center Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark Litzow, MD    507-284-2511    litzow.mark@mayo.edu   
Principal Investigator: Mark Litzow, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Peter Westervelt, MD    314-454-8323    pwesterv@im.wustl.edu   
Principal Investigator: Peter Westervelt, MD         
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Alfred P. Gillio, MD    201-996-5437    agillio@humed.com   
Principal Investigator: Alfred P. Gillio, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Maureen Ross, MD    716-845-2300    maureen.ross@roswellpark.org   
Principal Investigator: Maureen Ross, MD         
New York Presbyterian Weill Cornell Medical Center Recruiting
New York City, New York, United States, 10021
Contact: Tsiporah Shore, MD    212-746-2646    tbs2001@med.cornell.edu   
Principal Investigator: Tsiporah Shore, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ronald Sobecks, MD    216-445-4626    sobeckr@ccf.org   
Principal Investigator: Ronald Sobecks, MD         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Steven M. Devine, MD    614-293-6794    steven.devine@osumc.edu   
Principal Investigator: Steven M. Devine, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David Porter, MD    215-662-5858    david.porter@uphs.upenn.edu   
Principal Investigator: David Porter, MD         
United States, Texas
Baylor Sammons Cancer Center Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Edward Agura, MD       edward.agura@baylorhealth.edu   
Principal Investigator: Edward Agura, MD         
M.D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Richard Champlin, MD       rchampli@mdanderson.org   
Principal Investigator: Richard Champlin, MD         
Methodist Healthcare System of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Paul Shaughnessy, MD    210-575-8500    paul.shaughnessy@MHShealth.com   
Principal Investigator: Paul Shaughnessy, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Ann E Woolfrey, MD    206-667-4324    awoolfre@fhcrc.org   
Principal Investigator: Ann E Woolfrey, MD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Daniel Weisdorf, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided by Masonic Cancer Center, University of Minnesota

Additional 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: May 15, 2014
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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014