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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03921047

Enrollment

250

Registered

2019-04-19

Start date

2018-04-12

Completion date

2027-12-31

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Brief 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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

OTHERLaboratory Biomarker Analysis

Correlative studies

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of AML scheduled to undergo HSCT at University of Southern California (USC)

Exclusion criteria

* Inability to provide consent because of severe mental disorders * Donor unwilling to provide consent

Design outcomes

Primary

Measure	Time frame	Description
Time to diagnosis of acute graft versus (vs.) host disease (aGVHD)	Up to 4 years	Will be calculated as the time from stem cell infusion until the date of the diagnosis of aGVHD. If a patient dies prior to day 100 and does not have aGVHD, the patient will be censored at the time of death; all patients without aGVHD will be censored on day 100.
Time to diagnosis of relapse	Up to 4 years	Will be calculated as the time from stem cell infusion until the date of the of the diagnosis of relapse Patients who die of treatment toxicity or other cause, prior to relapse, will be censored at the time of death; all patients will be censored at 365 days following transplant.

Countries

United States

Contacts

CONTACTChristine Duran

Duran_C@med.usc.edu323-865-0371

PRINCIPAL_INVESTIGATORHouda Alachkar, PharmD, PhD

University of Southern California

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026