Selecting a Favorable KIR Donor in Unrelated HCT for AML
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|ClinicalTrials.gov Identifier: NCT01288222|
Recruitment Status : Active, not recruiting
First Posted : February 2, 2011
Last Update Posted : August 6, 2019
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.
- Favorable KIR donors will improve protection against relapse and improve leukemia free survival (LFS) after URD HCT for AML.
- 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 or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia||Biological: KIR genotype Biological: Unrelated donor transplant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||506 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
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
- Incidence of Relapse [ Time Frame: 2 Years ]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.
- Incidence of Relapse-Free Survival [ Time Frame: 2 Years ]
- Overall Survival [ Time Frame: 2 Years ]
- Incidence of Engraftment [ Time Frame: 2 Years ]
- Incidence of Graft Versus Host Disease [ Time Frame: 2 Years ]
- Incidence of Transplant Related Mortality [ Time Frame: 2 Years ]Number of patients who died within 2 years of transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288222
|Principal Investigator:||Daniel Weisdorf, M.D.||Masonic Cancer Center, University of Minnesota|