Acute Myelogenous Leukemia
Conditions
Keywords
acute myelogenous leukemia, hematopoietic cell transplantation, unrelated donor
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. 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.
Detailed description
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.
Interventions
OTHERKIR genotype
KIR genotype data from unrelated donor are collected
Sponsors
National Cancer Institute (NCI)
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Relapse | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of patients who died within 2 years of transplant. |
Countries
United States
Outcome results
None listed