Hematologic MalignancyNCT07189117
Cancer and Immune Cell Metabolism in Patients With Hematological Malignancies
An observational study of Hematologic Malignancy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study investigates how metabolism in cancer and immune cells shapes the bone marrow environment, influences therapy resistance, and affects outcomes in hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancy
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Oct 2025to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with hematological cancers: Adults (≥18 years) with MDS, AML, ALL, or primary/secondary myelofibrosis from whom blood and bone marrow samples will be collected during the disease course. Healthy donors: Adults (≥18 years) donating hematopoietic stem cells for allogeneic transplantation, providing peripheral blood or bone marrow samples as a source of healthy stem cells.
Who may be able to join
- age > 18 years,
- signed written informed consent
- For participants with hematological cancers: diagnosis of MDS, AML, ALL, PMF or post-ET/PV MF
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johannes Tossounidis, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Petya Apostolova, Prof. Dr., +41 61 328 48 40, petya.apostolova@unibas.ch
About this study
This study investigates how metabolism in cancer and immune cells shapes the bone marrow environment, influences therapy resistance, and affects outcomes in hematological malignancies.
Read the detailed description
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.
- Conditions
- Hematologic Malignancy
- Keywords
- allo-HSCT
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with hematological cancers | Not described | |
| Healthy stem cell donors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of metabolites
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.
Measured: 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)
Concentration of lipids
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.
Measured: 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)
Expression profiling
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.
Measured: 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
Metabolic function will be assessed by extracellular flux assays, flow cytometry, or another appropriate technique.
Measured: 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)
Secondary outcomes (4)
Response to treatment(s)
Measured: during whole study, up to 5 years after allo-HSCT
Duration of the response
Measured: during whole study, up to 5 years after allo-HSCT
Progression-free survival
Measured: during whole study, up to 5 years after allo-HSCT
Overall survival
Measured: during whole study, up to 5 years after allo-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start29 Oct 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petya Apostolova, Prof. Dr., Study chair, University Hospital of BaselJohannes Tossounidis, MD, Principal investigator, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189117
- Sponsor's protocol ID
- 2025-01775;th25Aposotolova
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer and Immune Cell Metabolism in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07189117
- Acronym / sponsor ID
- 2025-01775;th25Aposotolova
- Conditions
- Hematologic Malignancy
- Keywords
- allo-HSCT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates how metabolism in cancer and immune cells shapes the bone marrow environment, influences therapy resistance, and affects outcomes in hematological malignancies.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with hematological cancers | – | – |
| Healthy stem cell donors | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hematological cancers: Adults (≥18 years) with MDS, AML, ALL, or primary/secondary myelofibrosis from whom blood and bone marrow samples will be collected during the disease course. Healthy donors: Adults (≥18 years) donating hematopoietic stem cells for allogeneic transplantation, providing peripheral blood or bone marrow samples as a source of healthy stem cells.
Key inclusion criteria (3 listed)
- age > 18 years,
- signed written informed consent
- For participants with hematological cancers: diagnosis of MDS, AML, ALL, PMF or post-ET/PV MF
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Response to treatment(s)
Time frame: during whole study, up to 5 years after allo-HSCT
Duration of the response
Time frame: during whole study, up to 5 years after allo-HSCT
Progression-free survival
Time frame: during whole study, up to 5 years after allo-HSCT
Overall survival
Time frame: during whole study, up to 5 years after allo-HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Tossounidis, MD contact
Petya Apostolova, Prof. Dr. study chair
University Hospital of Basel
Johannes Tossounidis, MD principal investigator
University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petya Apostolova, Prof. Dr. (+41 61 328 48 40, petya.apostolova@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.