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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to provide consent because of severe mental disorders

Donor unwilling to provide consent

Trial population

Patients with AML scheduled to undergo HSCT

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Ancillary-correlative (next generation sequencing)2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 4 years
2

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.

Time frame
Up to 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

National Cancer Institute (NCI)

Collaborator