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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Myeloid Leukemia, in Relapse

Intervention / Treatment
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* Drug: Bicanorm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AML relapse under DLI and Bicanorm treatment<br>Analysis of T cell metabolism, immune phenotype and serum pH before and after Bicanorm (Sodium bicarbonate) treatment. | Drug: Bicanorm<br>* 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)<br>* Other names: Sodium bicarbonate;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum pH | Measurement of serum pH | 2 months |