[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03921047":3,"trial-entities:NCT03921047":88,"trial-summary:NCT03921047":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":22,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":57,"locations":60,"central_contacts":78,"overall_officials":83,"references":86,"see_also_links":87},"NCT03921047","9L-16-10","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","RECRUITING","2027-12-31","2026-05","2026-06-03","2018-04-12","University of Southern California","OTHER",true,"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.","PRIMARY OBJECTIVES:\n\nI. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients before and after receiving hematologic stem cell transplantation (HSCT).\n\nII. Identify molecular changes (germline variants and somatic mutations) that contribute to shaping the TCR repertoire.\n\nOUTLINE:\n\nPatents 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.",[19],"Acute Myeloid Leukemia",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},250,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"PROCEDURE","Biospecimen Collection","Undergo collection of blood samples",[33],"Ancillary-correlative (next generation sequencing)",{"type":14,"name":35,"description":36,"armGroupLabels":37},"Laboratory Biomarker Analysis","Correlative studies",[33],[39,43],{"measure":40,"description":41,"timeFrame":42},"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",{"measure":44,"description":45,"timeFrame":42},"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.",[],"ALL","18 Years",false,{"inclusion":51,"exclusion":53,"raw_text":56},[52],"Diagnosis of AML scheduled to undergo HSCT at University of Southern California (USC)",[54,55],"Inability to provide consent because of severe mental disorders","Donor unwilling to provide consent","Inclusion Criteria:\n\n* Diagnosis of AML scheduled to undergo HSCT at University of Southern California (USC)\n\nExclusion Criteria:\n\n* Inability to provide consent because of severe mental disorders\n* Donor unwilling to provide consent",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":75},"USC \u002F Norris Comprehensive Cancer Center","Los Angeles","California","90033","United States",[68,73],{"name":69,"role":70,"phone":71,"email":72},"Houda Alachkar","CONTACT","323-442-2696","alachkar@usc.edu",{"name":69,"role":74},"PRINCIPAL_INVESTIGATOR",{"lat":76,"lon":77},34.05223,-118.24368,[79],{"name":80,"role":70,"phone":81,"email":82},"Christine Duran","323-865-0371","Duran_C@med.usc.edu",[84],{"name":85,"affiliation":13,"role":74},"Houda Alachkar, PharmD, PhD",[],[],{"nct_id":4,"conditions":89,"biomarkers":90},[19],[],{"nct_id":4,"found":15,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an observational study planning to include 250 participants. It is not a drug trial, but rather focuses on understanding the immune system.","completed","Observational Study of T-cell Repertoire in AML Patients Undergoing Stem Cell Transplant","This research study is looking at the immune system in people with acute myeloid leukemia (AML) who are having a stem cell transplant. Researchers want to understand how the immune system's T-cells change before and after the transplant. By studying these T-cells, they hope to learn if the immune system plays a role in high-risk AML. You might be able to join if you have AML and are scheduled for a stem cell transplant at the University of Southern California (USC). The study will look at how long it takes for graft versus host disease (a condition where the donor's immune cells attack your body) or relapse (when the cancer comes back) to occur, for up to four years. The current recruitment status is unclear.","The study will follow participants for up to four years to track the time to diagnosis of acute graft versus host disease and relapse.",125,"You would have blood samples collected before, 100 days after, and one year after your stem cell transplant. If you are a donor, your blood would be collected at the time of transplant.","Not stated in the trial record.",[],"v2"]