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

University of Freiburg

Status and phase

Completed

Early Phase 1

Conditions

Acute Myeloid Leukemia, in Relapse

Treatments

Drug: Bicanorm

Study type

Interventional

Funder types

Other

Identifiers

NCT04321161

BICARB_AMLrelapse

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No 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