NCT01288222

Brief 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. 1.Favorable KIR donors will improve protection against relapse and improve leukemia free survival (LFS) after URD HCT for AML.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
506

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

8.8 years

First QC Date

February 1, 2011

Last Update Submit

March 9, 2021

Conditions

Acute Myelogenous Leukemia

Keywords

acute myelogenous leukemiahematopoietic cell transplantationunrelated donor

Outcome Measures

Primary Outcomes (1)

  • Incidence of Relapse

    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.

    2 Years

Secondary Outcomes (5)

  • Incidence of Relapse-Free Survival

    2 Years

  • Overall Survival

    2 Years

  • Incidence of Engraftment

    2 Years

  • Incidence of Graft Versus Host Disease

    2 Years

  • Incidence of Transplant Related Mortality

    2 Years

Study Arms (1)

Unrelated Donor Transplant Patients

EXPERIMENTAL

Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant.

Other: KIR genotype

Interventions

KIR genotypeOTHER

KIR genotype data from unrelated donor are collected

Unrelated Donor Transplant Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Mayo Clinic - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago Medical Center Cancer Center

Chicago, Illinois, 60637, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Kansas University Cancer Center

Kansas City, Kansas, 66160, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

New York Presbyterian Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78229, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

    PMID: 24748496DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Daniel Weisdorf, M.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 2, 2011

Study Start

June 1, 2011

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

US(19)