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

Status:	Recruiting
Conditions:	Blood Cancer, Leukemia
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	12/8/2018
Start Date:	May 2015
End Date:	May 2019
Contact:	Katharine Hsu, MD, PhD
Phone:	646-888-2667

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.

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.

We found this trial at

sites

Moffitt Cancer Center

Tampa, Florida 33612

Principal Investigator: Joseph Pidala, MD

Phone: 888-663-3488

from

Tampa, FL