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

ConditionLeukemia,Myeloid, Chronic

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCarmen Fava

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years old

Chronic Myeloid Leukemia Patients

Any stage of the disease

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

non interventional study with the use of biological samples.
Other intervention
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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.

Time frame

4 years

Sponsors and contacts

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Carmen Fava

Lead sponsor

University of Turin, Italy

Sponsor institution

Pfizer

Collaborator

Novartis

Collaborator

Source ClinicalTrials.gov

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