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

March 24, 2020 updated by: Robert Zeiser, University of Freiburg

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Medical Center University of Freiburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Bicanorm

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 Names:
  • Sodium bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T cell glycolytic activity
Time Frame: 2 months
Extracellular acidification rate (ECAR) determined by live-cell metabolic assay using the Seahorse Analyzer
2 months
T cell respiratory activity
Time Frame: 2 months
Oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer
2 months
T cell phenotype
Time Frame: 2 months
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
Time Frame: 2 months
Measurement of serum pH
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 25, 2020

Primary Completion (ACTUAL)

March 18, 2020

Study Completion (ACTUAL)

March 18, 2020

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (ACTUAL)

March 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BICARB_AMLrelapse

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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