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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04321161

Enrollment

Registered

2020-03-25

Start date

2020-02-25

Completion date

2020-03-18

Last updated

2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, in Relapse

Brief summary

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

Detailed description

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.

Interventions

DRUGBicanorm

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
T cell glycolytic activity	2 months	Extracellular acidification rate (ECAR) determined by live-cell metabolic assay using the Seahorse Analyzer
T cell respiratory activity	2 months	Oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer
T cell phenotype	2 months	T cell cytokine and effector molecule production determined by flow cytometric analysis

Secondary

Measure	Time frame	Description
Serum pH	2 months	Measurement of serum pH

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026