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

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT03921047
Collaborator
National Cancer Institute (NCI) (NIH)
200
1
69.7
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis

Detailed Description

PRIMARY OBJECTIVES:
  1. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients before and after receiving hematologic stem cell transplantation (HSCT).

  2. 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Apr 12, 2018
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm 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.

Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Laboratory Biomarker Analysis
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Houda Alachkar, PharmD, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern California
ClinicalTrials.gov Identifier:
NCT03921047
Other Study ID Numbers:
  • 9L-16-10
  • NCI-2017-02440
  • 9L-16-10
  • P30CA014089
First Posted:
Apr 19, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021