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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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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 Intervention/treatment
Acute Myeloid Leukemia Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis

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
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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 12, 2018
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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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
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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
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Information from the National Library of Medicine

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


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

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Houda Alachkar    323-442-2696    alachkar@usc.edu   
Principal Investigator: Houda Alachkar         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Houda Alachkar, PharmD, PhD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03921047    
Other Study ID Numbers: 9L-16-10
NCI-2017-02440 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9L-16-10 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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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.: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms