NCT03921047

Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant

Characterization of T-cell Repertoire in Patients With AML Undergoing HSCT Through Next-Generation Sequencing of T Cell Receptor Alpha (TCRA) and T Cell Receptor Beta (TCRB) Genes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research trial studies characterization of T-cell repertoire through next-generation sequencing in patients with acute myeloid leukemia undergoing stem cell transplant. Characterizing T-cell repertoire may help to understand if immune system plays a significant role in high risk patients with acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVES: I. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients before and after receiving hematologic stem cell transplantation (HSCT). II. Identify molecular changes (germline variants and somatic mutations) that contribute to shaping the TCR repertoire. OUTLINE: Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors undergo collection of blood at the time of HSCT for ribonucleic acid (RNA)-based next generation sequencing of TCRA and TCRB genes.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-04-12
• Primary completion: 2026-05-15
• Completion: 2027-05-15
• First posted: 2019-04-19
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States