NCT04321161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Feb 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

22 days

First QC Date

March 20, 2020

Last Update Submit

March 24, 2020

Conditions

Acute Myeloid Leukemia, in Relapse

Outcome Measures

Primary Outcomes (3)

  • T cell glycolytic activity

    Extracellular acidification rate (ECAR) determined by live-cell metabolic assay using the Seahorse Analyzer

    2 months

  • T cell respiratory activity

    Oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer

    2 months

  • T cell phenotype

    T cell cytokine and effector molecule production determined by flow cytometric analysis

    2 months

Secondary Outcomes (1)

  • Serum pH

    2 months

Study Arms (1)

AML relapse under DLI and Bicanorm treatment

EXPERIMENTAL

Analysis of T cell metabolism, immune phenotype and serum pH before and after Bicanorm (Sodium bicarbonate) treatment.

Drug: Bicanorm

Interventions

BicanormDRUG

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)

Also known as: Sodium bicarbonate
AML relapse under DLI and Bicanorm treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • age \< 18 years
  • lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (3)

  • Chang CH, Qiu J, O'Sullivan D, Buck MD, Noguchi T, Curtis JD, Chen Q, Gindin M, Gubin MM, van der Windt GJ, Tonc E, Schreiber RD, Pearce EJ, Pearce EL. Metabolic Competition in the Tumor Microenvironment Is a Driver of Cancer Progression. Cell. 2015 Sep 10;162(6):1229-41. doi: 10.1016/j.cell.2015.08.016. Epub 2015 Aug 27.

    PMID: 26321679BACKGROUND

  • Pilon-Thomas S, Kodumudi KN, El-Kenawi AE, Russell S, Weber AM, Luddy K, Damaghi M, Wojtkowiak JW, Mule JJ, Ibrahim-Hashim A, Gillies RJ. Neutralization of Tumor Acidity Improves Antitumor Responses to Immunotherapy. Cancer Res. 2016 Mar 15;76(6):1381-90. doi: 10.1158/0008-5472.CAN-15-1743. Epub 2015 Dec 30.

    PMID: 26719539BACKGROUND

  • Schmid C, Labopin M, Nagler A, Bornhauser M, Finke J, Fassas A, Volin L, Gurman G, Maertens J, Bordigoni P, Holler E, Ehninger G, Polge E, Gorin NC, Kolb HJ, Rocha V; EBMT Acute Leukemia Working Party. Donor lymphocyte infusion in the treatment of first hematological relapse after allogeneic stem-cell transplantation in adults with acute myeloid leukemia: a retrospective risk factors analysis and comparison with other strategies by the EBMT Acute Leukemia Working Party. J Clin Oncol. 2007 Nov 1;25(31):4938-45. doi: 10.1200/JCO.2007.11.6053. Epub 2007 Oct 1.

    PMID: 17909197BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Robert Zeiser, Prof. Dr.

    Medical Center University of Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Division of Tumor Immunology

Study Record Dates

First Submitted

March 20, 2020

First Posted

March 25, 2020

Study Start

February 25, 2020

Primary Completion

March 18, 2020

Study Completion

March 18, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)