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NCT Number: NCT04321161

Analysis of T Cell Metabolism in Relapsed AML Patients With DLIs and Bicanorm Treatment

In this study, the outcomes of relapsed AML patients receiving DLIs and Bicanorm (Sodium bicarbonate) were analyzed including T cell metabolism and immune phenotype.

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Key information

Conditions

Acute Myeloid Leukemia, in Relapse 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

Interventional

Phase

Early Phase 1

Primary location

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

Acute myeloid leukemia (AML) patients suffering from relapse after allogeneic hematopoietic cell transplantation (allo-HCT) have a poor survival outcome. Donor lymphocyte infusions (DLIs) to induce graft-versus-leukemia (GvL) effects have a limited survival benefit.

Extensive preclinical studies have shown a beneficial effect of sodium bicarbonate on metabolic fitness of leukemia-reactive T cells in GvL AML models. Therefore, the investigators aimed to investigate a potential benefit of Bicanorm (Sodium bicarbonate) treatment accompanying DLIs in relapsed AML patients. The investigators determined the metabolic and immune phenotype of T cells isolated from patients receiving DLIs before and after Bicanorm (Sodium bicarbonate) treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed AML relapse after allo-HCT
  • patients receiving DLIs
  • age ≥ 18 years
  • 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

Treatment and study plan

Bicanorm

Drug

Treatment of patients with relapsed AML after allo-HCT receiving DLIs with Bicanorm (1-1-1) for 7 days.

sodium hydrogen carbonate (1 g per 1 tablet) = sodium ion (11,9 mmol per 1 tablet) = sodium ion (273 mg per 1 tablet) = hydrogen carbonate ion (11,9 mmol per 1 tablet)

Other names: Sodium bicarbonate

Primary outcomes

  1. T cell glycolytic activity

    Time frame: 2 months

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

  2. T cell respiratory activity

    Time frame: 2 months

    Oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer

  3. T cell phenotype

    Time frame: 2 months

    T cell cytokine and effector molecule production determined by flow cytometric analysis

Secondary outcomes

  1. Serum pH

    Time frame: 2 months

    Measurement of serum pH

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

Analysis of T Cell Metabolism and Immune Phenotype in Relapsed Acute Myeloid Leukemia Patients Receiving Donor Lymphocyte Infusions and Bicanorm (Sodium Bicarbonate)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 25, 2020
Registry last updated
Mar 25, 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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