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

NCT06724536 | Recruiting

• 1 other identifier: MICROBIO-LMC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Leukemia,Myeloid, Chronic

Keywords

chronic myeloid leukemia; gut; microbiota; tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age \> 18 years old
• Chronic Myeloid Leukemia Patients
• Any stage of the disease
• none

Sponsors & Collaborators

• Carmen Fava: lead
• Pfizer: collaborator
• Novartis: collaborator

Study Sites (1)

AO Ordine Mauriziano di Torino

Torino, 10128, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and feces

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen Fava

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Fava

CONTACT

00390115082224; carmen.fava@unito.it

Valentina Bonuomo

CONTACT

00390115082224

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)