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

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ClinicalTrials.gov Identifier: NCT02450708
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
Center for International Blood and Marrow Transplant Research
Hackensack Meridian Health
H. Lee Moffitt Cancer Center and Research Institute
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
University of Washington
Mayo Clinic
Duke University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.


Condition or disease Intervention/treatment
Leukemia Genetic: KIR genotyping Genetic: HLA genotyping

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Study Type : Observational
Estimated Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Selection of Allogeneic Hematopoietic Cell Donors Based on KIR and HLA Genotypes
Actual Study Start Date : May 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Group/Cohort Intervention/treatment
For patients with 1 HLA-compatible donor for URD HCT
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
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



Primary Outcome Measures :
  1. relapse [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]
    Overall survival (OS). The time from study enrollment until death from any cause.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The trial will recruit potential transplant eligible participants with AML in clinic.
Criteria

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.

Information from the National Library of Medicine

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): NCT02450708


Contacts
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Contact: Katharine Hsu, MD, PhD 646-888-2667
Contact: Brian Shaffer, MD 212-639-2212

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Joseph Pidala, MD    888-663-3488      
Principal Investigator: Joseph Pidala, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, MD, PhD    404-778-2984      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Corey Cutler, MD    617-632-3470      
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark Litzow, MD       litzow.mark@mayo.edu   
United States, New Jersey
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Scott Rowley, MD    551-996-8297      
Principal Investigator: Scott Rowley, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Katherine Hsu, MD, PhD    646-888-2667      
Contact: Brian Schaffer, MD    212-639-2212      
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27701
Contact: David Rizzieri, MD    919-668-1040      
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Sumithira Vasu, MBBS    614-293-3196      
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Edward Agura, MD    214-820-1800      
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Joseph Pidala, MD    813-745-4673      
United States, Washington
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98109
Contact: Effie Petersdorf, MD    206-667-5244      
Principal Investigator: Effie Petersdorf, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Center for International Blood and Marrow Transplant Research
Hackensack Meridian Health
H. Lee Moffitt Cancer Center and Research Institute
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
University of Washington
Mayo Clinic
Duke University
Investigators
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Principal Investigator: Katherine Hsu, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02450708     History of Changes
Other Study ID Numbers: 15-059
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
Allogeneic Hematopoietic Cell Donors
KIR and HLA Genotypes
15-059