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
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