Leukemia,Myeloid, ChronicMICROBIO-LMCNCT06724536
Interaction Between Gut Microbiota and TKIs in Defining the Clinical Outcomes of Patients With CML
An observational study of Leukemia,Myeloid, Chronic, run by Carmen Fava at 1 site in Italy.
Trial summary
Gut microbiome (GM) is acquiring increasing importance in human health and disease. GM influences hematopoiesis and immune cells types differentiation. Patients with cancer are characterized by dysbiosis and compromised immunity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia,Myeloid, Chronic
- What is being tested?
- non interventional study with the use of biological samples.
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 1 Oct 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All hematologic patients of the the Hematology Division of the AO Ordine Mauriziano di Torino with a diagnosis of Philadelphia positive Chronic Myeloid Leukemia (CML) will be included.
Who may be able to join
- Age > 18 years old
- Chronic Myeloid Leukemia Patients
- Any stage of the disease
- Exclusioni Criteria:
- none
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valentina Bonuomo contact
Italy1 site, 1 recruiting
- Recruiting
AO Ordine Mauriziano di Torino
Torino, 10128
Carmen Fava, 00390115082224, carmen.fava@unito.it
About this study
Official title: Interaction Between Gut Microbiota and Tyrosine Kinase Inhibitors in Defining the Clinical Outcomes of Patients With Chronic Myeloid Leukemia
Gut microbiome (GM) is acquiring increasing importance in human health and disease. GM influences hematopoiesis and immune cells types differentiation. Patients with cancer are characterized by dysbiosis and compromised immunity. In the case of Chronic Myeloid Leukemia (CML), treatment with Tyrosine Kinase Inhibitors (TKIs) restores immunosurveillance; in particular deep molecular response (DMR) is associated with increased levels of NK and CD8+ Tcells. There is no literature on the effects of GM on CML outcomes. This project aims to identify a microbial signature associated with a higher probability of achieving DMR.
Read the detailed description
Philadelphia positive Chronic Myeloid Leukemia (CML) is a myeloproliferative disorder originating from pluripotent hematopoietic cells. Treatment typically involves tyrosine-kinase inhibitors (TKIs), which have significantly improved long-term survival. While generally well-tolerated, TKIs can cause side effects, particularly gastrointestinal issues (diarrhea, constipation, abdominal pain, malabsorption, bleeding) and liver/pancreatic enzyme increases, which may persist and affect quality of life. Additionally, cardiovascular events, often linked to metabolic changes (e.g., glucose intolerance, diabetes, hypertension), occur more frequently during treatment. These side effects raise concerns about TKIs potentially inducing a chronic inflammatory response.
Recent research on the human microbiota highlights its importance in health. The microbiota plays a critical role in gut health, immune function, and metabolic processes, and its imbalances (dysbiosis) can contribute to a range of diseases. Factors such as diet, age, physical activity, and medication use can disrupt the microbiota. However, the relationship between gut microbiota and TKIs in CML patients remains unexplored.
The current study will evaluate by whether different CML gut microbiota genotypes influence TKI treatment responses, whether microbiota alterations cause inflammation or metabolic disorders, and whether microbiota, along with dysmetabolism and dysimmunity, contribute to variations in treatment efficacy and tolerance
- Conditions
- Leukemia,Myeloid, Chronic
- Being tested
- non interventional study with the use of biological samples.
- Keywords
- chronic myeloid leukemia, gut, microbiota, tyrosine kinase inhibitors
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventional study with the use of biological samples.Other
Patients will undergo to the follow evaluations:
Gut microbiome on stool samples by NGS (16S rRNA gene amplicon sequencing); Markers of impaired intestinal permeability [diaminoxidase (DAO), serum zonulin], and markers of inflammation of the GI tract (fecal calprotectin); Plasma inflammatory indices, cytokines (by Luminex), markers of autoimmunity, and metabolic profile; Acquired and adaptive immunity by multiparametric flow cytometry on PB samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
genotypes of the intestinal microbiota and responses to treatment with TKI.
The primary objective is to assess the association between genotypes of the intestinal microbiota (in eubiosis or dysbiosis) of patients with CML and responses (efficacy and tolerability in the short and long term) to treatment with TKI.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia,Myeloid, ChronicStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmen Fava
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Novartis
- Responsible party
- Sponsor-investigator, Carmen Fava, University of Turin, Italy
- Investigators
- Carmen Fava, Principal investigator, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724536
- Sponsor's protocol ID
- MICROBIO-LMC
- Acronym
- MICROBIO-LMC
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Gut Microbiota and Tyrosine Kinase Inhibitors in Defining the Clinical Outcomes of Patients With Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06724536
- Acronym / sponsor ID
- MICROBIO-LMC / MICROBIO-LMC
- Conditions
- Leukemia,Myeloid, Chronic
- Keywords
- chronic myeloid leukemia, gut, microbiota, tyrosine kinase inhibitors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Carmen FavaUniversity, hospital or other
- Collaborators
- Pfizer, Novartis
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
Gut microbiome (GM) is acquiring increasing importance in human health and disease. GM influences hematopoiesis and immune cells types differentiation. Patients with cancer are characterized by dysbiosis and compromised immunity. In the case of Chronic Myeloid Leukemia (CML), treatment with Tyrosine Kinase Inhibitors (TKIs) restores immunosurveillance; in particular deep molecular response (DMR) is associated with increased levels of NK and CD8+ Tcells. There is no literature on the effects of GM on CML outcomes. This project aims to identify a microbial signature associated with a higher probability of achieving DMR.
Detailed description
Philadelphia positive Chronic Myeloid Leukemia (CML) is a myeloproliferative disorder originating from pluripotent hematopoietic cells. Treatment typically involves tyrosine-kinase inhibitors (TKIs), which have significantly improved long-term survival. While generally well-tolerated, TKIs can cause side effects, particularly gastrointestinal issues (diarrhea, constipation, abdominal pain, malabsorption, bleeding) and liver/pancreatic enzyme increases, which may persist and affect quality of life. Additionally, cardiovascular events, often linked to metabolic changes (e.g., glucose intolerance, diabetes, hypertension), occur more frequently during treatment. These side effects raise concerns about TKIs potentially inducing a chronic inflammatory response.
Recent research on the human microbiota highlights its importance in health. The microbiota plays a critical role in gut health, immune function, and metabolic processes, and its imbalances (dysbiosis) can contribute to a range of diseases. Factors such as diet, age, physical activity, and medication use can disrupt the microbiota. However, the relationship between gut microbiota and TKIs in CML patients remains unexplored.
The current study will evaluate by whether different CML gut microbiota genotypes influence TKI treatment responses, whether microbiota alterations cause inflammation or metabolic disorders, and whether microbiota, along with dysmetabolism and dysimmunity, contribute to variations in treatment efficacy and tolerance
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All hematologic patients of the the Hematology Division of the AO Ordine Mauriziano di Torino with a diagnosis of Philadelphia positive Chronic Myeloid Leukemia (CML) will be included.
Key inclusion criteria (5 listed)
- Age > 18 years old
- Chronic Myeloid Leukemia Patients
- Any stage of the disease
- none
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventional study with the use of biological samples.Patients will undergo to the follow evaluations: Gut microbiome on stool samples by NGS (16S rRNA gene amplicon sequencing); Markers of impaired intestinal permeability [diaminoxidase (DAO), serum zonulin], and markers of inflammation of the GI tract (fecal calprotectin); Plasma inflammatory indices, cytokines (by Luminex), markers of autoimmunity, and metabolic profile; Acquired and adaptive immunity by multiparametric flow cytometry on PB samples. | Other | – |
Primary outcome
genotypes of the intestinal microbiota and responses to treatment with TKI.
Time frame: 4 years
The primary objective is to assess the association between genotypes of the intestinal microbiota (in eubiosis or dysbiosis) of patients with CML and responses (efficacy and tolerability in the short and long term) to treatment with TKI.
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 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Leukemia,Myeloid, Chronic
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Valentina Bonuomo contact
Carmen Fava principal investigator
Department of Clinical and Biological Sciences, University of Turin, Turin, Italy
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 Leukemia,Myeloid, Chronic, run by Carmen Fava at 1 site in Italy.
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 5 inclusion and 0 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 9 Dec 2024. 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 Italy. 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 Carmen Fava (00390115082224, carmen.fava@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genotypes of the intestinal microbiota and responses to treatment with TKI. (time frame: 4 years). 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 9 Dec 2024.