Trial record 1 of 1 for:    NCT01288222
Previous Study | Return to List | Next Study

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

February 1, 2011
May 15, 2014
June 2011
July 2015   (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
Cooley S, Weisdorf DJ, Guethlein LA, Klein JP, Wang T, Marsh SG, Spellman S, Haagenson MD, Saeturn K, Ladner M, Trachtenberg E, Parham P, Miller JS. Donor killer cell Ig-like receptor B haplotypes, recipient HLA-C1, and HLA-C mismatch enhance the clinical benefit of unrelated transplantation for acute myelogenous leukemia. J Immunol. 2014 May 15;192(10):4592-600. doi: 10.4049/jimmunol.1302517. Epub 2014 Apr 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
July 2015
July 2015   (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

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).

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
May 2014

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