USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Location status: Recruiting
Recruiting
NCT Number: NCT03921047
Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Biospecimen Collection
ProcedureUndergo collection of blood samples
laboratory biomarker analysis
OtherCorrelative studies
Primary outcomes
-
Time to diagnosis of acute graft versus (vs.) host disease (aGVHD)
Time frame: 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
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Southern California
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study 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
Important dates
- Study start
- 2018
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Apr 19, 2019
- Registry last updated
- Jun 3, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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