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

NCT03921047 | Recruiting DMC

• 3 other identifiers: 9L-16-10NCI-2017-02440P30CA014089
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

  Up to 4 years

Study Arms (1)

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; Other: Laboratory Biomarker Analysis

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Ancillary-correlative (next generation sequencing)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-correlative (next generation sequencing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AML scheduled to undergo HSCT

You may qualify if:

• Diagnosis of AML scheduled to undergo HSCT at University of Southern California (USC)

You may not qualify if:

• Inability to provide consent because of severe mental disorders
• Donor unwilling to provide consent

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Houda Alachkar, PharmD, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Duran

CONTACT

323-865-0371; Duran_C@med.usc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: April 12, 2018
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)