Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Laboratory Biomarker Analysis.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Procedure Biospecimen Collection
Undergo collection of blood samples - Other Laboratory Biomarker Analysis
Correlative studies
Primary outcome measures
- Time to diagnosis of acute graft versus (vs.) host disease (aGVHD) [Time frame: Up to 4 years]
- Time to diagnosis of relapse [Time frame: Up to 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- USC / Norris Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT03921047 · 9L-16-10 · NCI-2017-02440 · 9L-16-10 · P30CA014089