Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT03921047|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia||Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis|
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.
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|
|Estimated Enrollment :||200 participants|
|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 :||April 12, 2018|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2023|
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
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921047
|Contact: Christine Duran||323-865-0371||Duran_C@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Houda Alachkar 323-442-2696 firstname.lastname@example.org|
|Principal Investigator: Houda Alachkar|
|Principal Investigator:||Houda Alachkar, PharmD, PhD||University of Southern California|