Investigation of the Gut Microbiota in Acute Myeloid Leukemia Receiving Two Different Induction Therapies

NCT05123352 | Unknown

• 1 other identifier: AML-GutMicrobiota01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this observational single-center cohort study, metagenomic Next-Generation Sequencing (mNGS) will be used to investigate the features and changes of gut microbiota in acute myeloid leukemia (AML) patients during the treatment of two different induction therapy regimens \[standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy\].

Conditions

Acute Myeloid Leukemia; Adult; Gut Microbiota; Infections

Outcome Measures

Primary Outcomes (2)

• Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after induction therapy

  Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients

  Day 0 i.e.: feces sampling is done at time of diagnosis before induction therapy

• Changes in metabolites composition of blood in patients with acute myeloid leukemia before, during and after induction therapy

  Metabolomics performed on patients' blood to report the metabolites composition in those patients

  Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy

Secondary Outcomes (5)

• Changes in immune cells of blood in patients with acute myeloid leukemia before, during and after induction therapy

  Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy

• Changes of gut permeability markers and microbial compounds of blood in patients with acute myeloid leukemia before, during and after induction therapy

  Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy

• Infection rate during induction therapy

  From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.

• Rate of complete remission

  From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.

• Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0

  From date of first one cycle induction therapy start to the end of Cycle 1 (each cycle is 28 days) or death from any cause during Cycle 1 induction therapy.

Study Arms (2)

Standard intensive chemotherapy

Patients with acute myeloid leukemia in this cohort will receive standard induction chemotherapy that combines seven days of cytarabine and three days of anthracycline (7+3 regimen).

Other: collection of biological samples and clinical data

Bcl-2 inhibitor-based targeted therapy

Patients with acute myeloid leukemia in this cohort will receive Bcl-2 inhibitor-based targeted therapy, such as combination of bcl-2 inhibitor plus decitabine/azacitidine with or without sorafenib.

Other: collection of biological samples and clinical data

Interventions

collection of biological samples and clinical data OTHER

blood and feces samples

Bcl-2 inhibitor-based targeted therapy; Standard intensive chemotherapy

Eligibility Criteria

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

Study Population

Candidates will come from patients with newly diagnosed acute myeloid leukemia (AML) in the First Affiliated Hospital of Soochow University from November 2021. Participants should meet the inclusion criteria and not meet exclusion criteria.

You may qualify if:

• Male or female, 65\> =Age (years) \>= 18;
• Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1,2;
• Patients will receive standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy;
• Patients have not received prior therapy for AML (except hydroxycarbamide);
• Liver function: Total bilirubin lower than 3 upper limit of normal (ULN); Aspartate aminotransferase (AST) lower than 3 ULN; Alanine aminotransferase (ALT) lower than 3 ULN (except extramedullary infiltration of leukemia);
• Renal function with creatinine clearance rate (Ccr) higher than 30 ml/min;
• Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

You may not qualify if:

• Acute promyeloid leukemia;
• AML with central nervous system (CNS) infiltration;
• Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance) or gastrointestinal surgery;
• HIV infection, Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment;
• Severe and active infection that is difficult to control and cannot tolerate induction therapy;
• Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen;
• Antibiotic exposure within 30 days before enrollment (carbapenems and/or tigecycline were not included, penicillin, cephalosporins and quinolones could be included)
• Patients reject to participate in the study;
• Patients with severe heart failure (grade 3-4) or patients deemed unsuitable for enrolment by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Infections

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Suning Chen, professor

  The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suning Chen, professor

CONTACT

8613814881746; chensuning@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 17, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-10

Locations

CN (1)