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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02450708
• Other study ID #: 15-059
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 511
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Leukemia

Intervention

Genetic:
• KIR genotyping

• HLA genotyping

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	Md Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	University of Washington School of Medicine	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (9)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival	Overall survival (OS). The time from study enrollment until death from any cause.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center