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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Biospecimen Collection

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Christine Duran; Phone Number: 323-865-0371; Email: duran_c@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: Houda Alachkar; Phone Number: 323-442-2696; Email: alachkar@usc.edu
      • Principal Investigator: Houda Alachkar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with AML scheduled to undergo HSCT

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-correlative (next generation sequencing); 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Biospecimen Collection; Undergo collection of blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to diagnosis of acute graft versus (vs.) host disease (aGVHD)	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.	Up to 4 years
Time to diagnosis of relapse	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.	Up to 4 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Houda Alachkar, PharmD, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 9L-16-10 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2017-02440 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No