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Interaction Between Gut Microbiota and TKIs in Defining the Clinical Outcomes of Patients With CML

NCT ID: NCT06724536

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-10-01

Brief Summary

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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

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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

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Leukemia,Myeloid, Chronic

Keywords

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chronic myeloid leukemia gut microbiota tyrosine kinase inhibitors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old
* Chronic Myeloid Leukemia Patients
* Any stage of the disease

Exclusioni Criteria:

none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Carmen Fava

OTHER

Sponsor Role lead

Responsible Party

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Carmen Fava

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carmen Fava

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical and Biological Sciences, University of Turin, Turin, Italy

Locations

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AO Ordine Mauriziano di Torino

Torino, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carmen Fava

Role: CONTACT

Phone: 00390115082224

Email: [email protected]

Valentina Bonuomo

Role: CONTACT

Phone: 00390115082224

Facility Contacts

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Carmen Fava

Role: primary

Other Identifiers

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MICROBIO-LMC

Identifier Type: -

Identifier Source: org_study_id