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| Name | Class |
|---|---|
| Center for International Blood and Marrow Transplant Research | NETWORK |
| Hackensack Meridian Health | OTHER |
| H. Lee Moffitt Cancer Center and Research Institute | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KIR genotyping | Genetic |
| ||
| HLA genotyping |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Overall survival (OS). The time from study enrollment until death from any cause. | 1 year |
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Inclusion Criteria:
RECIPIENT
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Hsu, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Dana Farber Cancer Institute |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| M.D. Anderson Cancer Center |
| OTHER |
| Dana-Farber Cancer Institute | OTHER |
| University of Washington | OTHER |
| Mayo Clinic | OTHER |
| Duke University | OTHER |
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| Genetic |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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