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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03921047

Recruitment Status Recruiting

First Posted April 19, 2019

Last update posted May 14, 2019

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:Acute Myeloid Leukemia
  • Intervention/Treatment: Procedure: Biospecimen Collection
    Other: Laboratory Biomarker Analysis
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Estimated 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: April 2018
  • Estimated Primary Completion Date: February 2022
  • Estimated Study Completion Date: February 2023
Groups and Cohorts
Groups/Cohorts 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) [ 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.
  • 2. 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

    Blood

Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Patients with AML scheduled to undergo HSCT
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

Contacts and Locations
Contacts

Contact: Christine Duran 323-865-0371 Duran_C@med.usc.edu

Locations

United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles

Sponsors and Collaborators

University of Southern California

National Cancer Institute (NCI)

Investigators

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

More Information
  • Responsible Party: University of Southern California
  • ClinicalTrials.gov Identifier: NCT03921047 History of Changes
  • Other Study ID Numbers: 9L-16-10, NCI-2017-02440, 9L-16-10, P30CA014089
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: May 14, 2019
  • Last Verified: May 2019
  • 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.: Yes
  • Additional relevant MeSH terms: Leukemia, Myeloid, Acute
    Leukemia
    Leukemia, Myeloid