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

Early Phase 1

Completed

• Conditions: Acute Myeloid Leukemia, in Relapse
• Interventions: Drug: Bicanorm

• Registration Number: NCT04321161
• Lead Sponsor: University of Freiburg

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.

Study Timeline

• Study Start: 2020-02-25
• Status Verified: 2020-03
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-24
• Last Update Submitted: 2020-03-24
• Study First Posted: 2020-03-25
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AML relapse under DLI and Bicanorm treatment	Bicanorm	Analysis of T cell metabolism, immune phenotype and serum pH before and after Bicanorm (Sodium bicarbonate) treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum pH	2 months	Measurement of serum pH

Trial Locations

Locations (1)

Medical Center University of Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany