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Trial record 1 of 1 for:    NCT04321161
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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
Sponsor:
Information provided by (Responsible Party):
Robert Zeiser, 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia, in Relapse Drug: Bicanorm Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


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 Name: Sodium bicarbonate




Primary Outcome Measures :
  1. T cell glycolytic activity [ Time Frame: 2 months ]
    Extracellular acidification rate (ECAR) determined by live-cell metabolic assay using the Seahorse Analyzer

  2. T cell respiratory activity [ Time Frame: 2 months ]
    Oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer

  3. T cell phenotype [ Time Frame: 2 months ]
    T cell cytokine and effector molecule production determined by flow cytometric analysis


Secondary Outcome Measures :
  1. Serum pH [ Time Frame: 2 months ]
    Measurement of serum pH



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Germany
Medical Center University of Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Sponsors and Collaborators
University of Freiburg
Investigators
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Principal Investigator: Robert Zeiser, Prof. Dr. Medical Center University of Freiburg
Publications:
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Responsible Party: Robert Zeiser, Director of the Division of Tumor Immunology, University of Freiburg
ClinicalTrials.gov Identifier: NCT04321161    
Other Study ID Numbers: BICARB_AMLrelapse
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms