Selection of Allogeneic Hematopoietic Cell Donors Based on KIR and HLA Genotypes

NCT02450708 | Active Not Recruiting

• 1 other identifier: 15-059
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 10

Brief Summary

This study tests whether adding certain genetic factors to the process of picking a stem cell donor can decrease the chances that the patient's leukemia will come back after bone marrow transplantation. Stem cell donors are "matched" based on genes called human leukocyte antigens (HLA). Currently, donors are selected largely on the basis of HLA gene typing alone. There is published data to show that donors with specific other genes called killer immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia return after a transplant. In this study, the best HLA matched donors will be tested for the KIR genes. If there is more than 1 donor available, a recommendation will be provided to study doctors as to which donors have potentially favorable KIR genes. The study doctors may or may not choose to use this donor for transplant or not based on his/her own judgment. Transplant care will not change otherwise as a result of this study. This study is being done to demonstrate that AML patients who have donors with specific KIR and HLA genes will have a better outcome following transplant.

Conditions

Leukemia

Keywords

Allogeneic Hematopoietic Cell Donors; KIR and HLA Genotypes; 15-059

Outcome Measures

Primary Outcomes (1)

• relapse

  Demonstration of evidence of leukemia (\>5% blasts in the bone marrow, peripheral blood blasts, or development of extramedullary disease) after initial achievement of either a CR or CRi.

  1 year

Secondary Outcomes (1)

• overall survival

  1 year

Study Arms (2)

For patients with 1 HLA-compatible donor for URD HCT

EXPERIMENTAL

For patients with 1 URD: donor KIR genotyping will be performed on the donor. Because donor selection will not depend on KIR/HLA genotyping, completion of donor KIR genotyping is not required prior to transplant.

Genetic: HLA genotyping

For patients with >1 HLA-compatible donor for URD HCT

EXPERIMENTAL

For patients with 1 or more donor candidates, KIR genotyping may be performed for up to 5 donors. For patients with HLA-B alleles harboring the Bw4 epitope, KIR3DL1 allele typing will be performed at MSKCC.

Genetic: KIR genotyping; Genetic: HLA genotyping

Interventions

KIR genotyping GENETIC

For patients with >1 HLA-compatible donor for URD HCT

HLA genotyping GENETIC

For patients with 1 HLA-compatible donor for URD HCT; For patients with >1 HLA-compatible donor for URD HCT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• RECIPIENT
• Persons of all ages are eligible for this study.
• Patient must have diagnosis of acute myelogenous leukemia (AML) at MSK or a collaborating treating institution. Patients with de novo AML or AML with preceding myelodysplastic syndrome (MDS) are eligible.
• Patient must be a potential candidate for an unrelated transplantation procedure at the time of enrollment even though patient may not be eligible for transplantation in the future due to relapse or presence of co-morbidity(ies).
• An unrelated donor does not need to be identified at the time of enrollment. If an HLA-compatible unrelated donor is not identified for the patient, the patient will be removed from the study.

You may not qualify if:

• Recipients with an available sibling donor matched at HLA-A, HLA-C, and HLA-DRB1 (excluding identical twin siblings).
• Patients for whom post-transplant treatment is planned are not excluded from enrollment.
• Patients with prior allogeneic hematopoietic cell transplantation for AML. Note: Patients who have undergone prior hematopoietic cell transplantation for a diagnosis other than AML are still eligible for this study.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Center for International Blood and Marrow Transplant Research: collaborator
• Hackensack Meridian Health: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• M.D. Anderson Cancer Center: collaborator
• Dana-Farber Cancer Institute: collaborator
• University of Washington: collaborator
• Mayo Clinic: collaborator
• Duke University: collaborator

Study Sites (10)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98109, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Katherine Hsu, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

US (10)