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

Status
Active
Cancer Type
Trial Phase
Eligibility
0 Years and older, Male and Female
Study Type
Other
NCT ID
NCT02450708
Protocol IDs
15-059 (primary)
NCI-2016-01694
Study Sponsor
Memorial Sloan Kettering Cancer Center

Summary

This research trial studies KIR and HLA genotyping in selecting donor cells for patients with acute myeloid leukemia undergoing stem cell transplant. Donors with specific KIR and HLA genes may decrease the chances of leukemia coming back in patients after stem cell transplantation.

Objectives

PRIMARY OBJECTIVES:
I. To determine if risk for relapse is lowered among patients with KIR advantageous donors.

SECONDARY OBJECTIVES:
I. To demonstrate improved survival and disease-free survival among patients with KIR advantageous donors.
II. To determine the probability that a KIR advantageous donor is identified for patients > 1 unrelated hematopoietic cell donor (URD).
III. To identify the likelihood that a KIR advantageous donor is successfully selected for further donor workup.
IV. To demonstrate reduced incidence of cytomegalovirus (CMV) reactivation and graft versus host disease (GVHD) with KIR advantageous donors.

OUTLINE:
Patient samples and previously collected URD DNA samples are tested for HLA allele type according to standard typing procedures. Following confirmation of URD HLA-compatibility, up to 5 HLA-compatible URD DNA samples are tested for KIR gene and allele type over 72 hours using polymerase chain reaction (PCR) - sequence specific primers (SSP) or sequence specific oligonucleotide probe (SSOP) methods. For patients and donors with allotypes exhibiting the HLA-Bw4 epitope, samples are tested for KIR3DL1 allele type using a 5-reaction PCR-SSP. After selection of HLA-compatible and KIR-advantageous or non-advantageous URD, patients undergo hematopoietic stem cell transplantation.

After completion of study, patients are followed up every 6 months for up to 5 years.

Treatment Sites in Georgia

Emory University School of Medicine


1440 Clifton Road
Atlanta, GA 30322


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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