Trial record 1 of 1 for:    NCT01288222
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Selecting a Favorable KIR Donor in Unrelated HCT for AML

This study is currently recruiting participants.
Verified October 2013 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: October 8, 2013
Last verified: October 2013

February 1, 2011
October 8, 2013
March 2011
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01288222 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Selecting a Favorable KIR Donor in Unrelated HCT for AML
KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor

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.

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

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myelogenous Leukemia
  • 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
Experimental: Unrelated Donor Transplant Patients
Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant.
Interventions:
  • Biological: KIR genotype
  • Biological: Unrelated donor transplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact: Daniel Weisdorf, M.D. 612-624-0123 weisd001@umn.edu
Contact: Judy Witte, R.N. 612-626-0169 mirab001@umn.edu
United States
 
NCT01288222
2010LSUC043, MT2010-06, P01CA111412
No
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Principal Investigator: Daniel Weisdorf, M.D. Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP