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NCT Number: NCT07189117

Cancer and Immune Cell Metabolism in Patients With Hematological Malignancies

This study investigates how metabolism in cancer and immune cells shapes the bone marrow environment, influences therapy resistance, and affects outcomes in hematological malignancies.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Hematological malignancies, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myelofibrosis, are aggressive cancers of the blood and immune system. While chemotherapy is commonly used, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative option for many patients. Allo-HSCT relies on donor immune cells, particularly T cells, to eliminate residual malignant cells, but relapse occurs in a significant proportion of patients, underscoring the need for improved therapeutic strategies.

Recent research has highlighted the critical role of cellular metabolism in both cancer cell survival and immune cell function. AML cells, for example, rely on mitochondrial respiration, while immune cells are sensitive to metabolic changes in the bone marrow microenvironment. These metabolic interactions may influence disease progression, therapy resistance, and immune-mediated anti-tumor responses, yet they remain poorly understood.

The primary goal of this study is to investigate how cancer and immune cell metabolism shapes the bone marrow environment and influences treatment outcomes in patients with hematological malignancies. By performing detailed metabolic profiling of malignant cells, immune cells, and extracellular metabolites across disease stages and treatment time points, the study aims to identify key metabolic pathways and interactions that could serve as targets for novel therapies and guide personalized treatment approaches.

This research is expected to deepen the understanding of metabolic mechanisms underlying hematological cancers and allo-HSCT outcomes, potentially leading to improved strategies to enhance anti-tumor immunity, prevent relapse, and optimize patient-specific therapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years,
  • signed written informed consent
  • For participants with hematological cancers: diagnosis of MDS, AML, ALL, PMF or post-ET/PV MF

Exclusion criteria

  • pregnant or lactating women,
  • inability to give consent,
  • active malignant disease (other than MDS, AML, ALL, PMF or post-ET/PV MF in the last 3 - years prior to study inclusion).
  • For healthy donors: previous or current hematological disease, previous or current other malignant disease,

Treatment and study plan

Primary outcomes

  1. Concentration of metabolites

    Time frame: at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

    the concentration of metabolites in malignant cells, immune cells, and extracellular fluid in each sample at the time point at which the sample is obtained. Metabolite and lipid concentrations will be measured by mass spectrometry.

  2. Concentration of lipids

    Time frame: at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

    the concentration of lipids in malignant cells, immune cells, and extracellular fluid in each sample at the time point at which the sample is obtained. Metabolite and lipid concentrations will be measured by mass spectrometry.

  3. Expression profiling

    Time frame: at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

    the expression of metabolite-related genes and proteins that will be measured by (single-cell) RNA-sequencing, quantitative polymerase chain reaction (PCR), proteomics, flow cytometry, western blotting, or another appropriate technique.

  4. Metabolic function

    Time frame: at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

    Metabolic function will be assessed by extracellular flux assays, flow cytometry, or another appropriate technique.

Secondary outcomes

  1. Response to treatment(s)

    Time frame: during whole study, up to 5 years after allo-HSCT

  2. Duration of the response

    Time frame: during whole study, up to 5 years after allo-HSCT

  3. Progression-free survival

    Time frame: during whole study, up to 5 years after allo-HSCT

  4. Overall survival

    Time frame: during whole study, up to 5 years after allo-HSCT

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Tossounidis, MD

CONTACT

[email protected]

Petya Apostolova, Prof. Dr.

CONTACT

[email protected]

+41 61 328 48 40

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2025
Primary completion
2035
Study completion
2040
First posted
Sep 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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