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

University of Southern California

Status: Enrolling

Conditions: Acute Myeloid Leukemia

Treatments: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03921047

9L-16-10 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2017-02440 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

250 participants in 1 patient group

Ancillary-correlative (next generation sequencing)

Description:

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 RNA-based next generation sequencing of TCRA and TCRB genes.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Biospecimen Collection