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Completed

NCT Number: NCT04259372

Analysis of T Cell Metabolism in Acute Myeloid Leukemia Patients

The objective of this study was to analyze the T cell metabolism and immune phenotype in AML patients during the course of the disease before and after allo-HCT.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Patients who experience relapse of acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HCT) have a dismal prognosis. Infusion of donor T cells can induce graft-versus-leukemia (GVL) effects, indicating the importance of intact T cell function for leukemia control. Recent studies have shown the importance of metabolic fitness for an effective T cell response.

In this study we have analyzed the T cell metabolism and immune phenotype in AML patients at different time points before and after allo-HCT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed diagnosis of AML
  • age ≥ 18 years
  • peripheral blood sample available
  • written informed consent
  • ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion criteria

  • age < 18 years
  • lack of informed consent
  • patients that cannot be classified in one of the 3 groups

Treatment and study plan

Primary outcomes

  1. T cell metabolism

    Time frame: 4 years

    Extracellular acidification rate (ECAR) and oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer

  2. T cell phenotype

    Time frame: 4 years

    T cell cytokine and effector molecule production

Secondary outcomes

  1. Metabolite abundance in serum

    Time frame: 4 years

    Serum metabolites as measured by mass spectrometry

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

Analysis of T Cell Metabolism and Immune Phenotype During the Course of Acute Myeloid Leukemia

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2020
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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