Analysis of T Cell Metabolism in Relapsed AML Patients With DLIs and Bicanorm Treatment
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|ClinicalTrials.gov Identifier: NCT04321161|
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia, in Relapse||Drug: Bicanorm||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analysis of T Cell Metabolism and Immune Phenotype in Relapsed Acute Myeloid Leukemia Patients Receiving Donor Lymphocyte Infusions and Bicanorm (Sodium Bicarbonate)|
|Actual Study Start Date :||February 25, 2020|
|Actual Primary Completion Date :||March 18, 2020|
|Actual Study Completion Date :||March 18, 2020|
Experimental: AML relapse under DLI and Bicanorm treatment
Analysis of T cell metabolism, immune phenotype and serum pH before and after Bicanorm (Sodium bicarbonate) treatment.
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 Name: Sodium bicarbonate
- T cell glycolytic activity [ Time Frame: 2 months ]Extracellular acidification rate (ECAR) determined by live-cell metabolic assay using the Seahorse Analyzer
- T cell respiratory activity [ Time Frame: 2 months ]Oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer
- T cell phenotype [ Time Frame: 2 months ]T cell cytokine and effector molecule production determined by flow cytometric analysis
- Serum pH [ Time Frame: 2 months ]Measurement of serum pH
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321161
|Medical Center University of Freiburg|
|Freiburg, Baden-Württemberg, Germany, 79106|
|Principal Investigator:||Robert Zeiser, Prof. Dr.||Medical Center University of Freiburg|