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

Acute Myeloid Leukemia Clinical Trial

Official title:

Investigation of the Gut Microbiota Evaluated by Metagenomic Next-Generation Sequencing (mNGS) in Acute Myeloid Leukemia Receiving Standard Intensive Chemotherapy or Bcl-2 Inhibitor-based Targeted Induction Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05123352
• Other study ID #: AML-GutMicrobiota01
• Status: Not yet recruiting
• Start date: November 2021
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: Suning Chen, professor
• Phone: 8613814881746
• Email: chensuning[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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].

Description:

Infections remain one of the major complications during induction therapy of acute myelocytic leukemia (AML). Previous studies have shown that the variation of gut microbiota was an effective predictor for infection development of AML during induction therapy. A growing number of patients with AML received bcl-2 inhibitor-based targeted induction therapy. The investigators assume that there are different effects of bcl-2 inhibitor-based induction therapy on gut microbiota compared with standard intensive chemotherapy (7+3 regimen). Metagenomic Next-Generation Sequencing (mNGS) will be used to perform the investigation of gut microbiota in AML receiving two different induction therapies. And the relationships of gut microbiota with infection complication will be analyzed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female, 65> =Age (years) >= 18;

2. Newly diagnosed as AML patients according to World Health Organization (WHO) classification;

3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1,2;

4. Patients will receive standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy;

5. Patients have not received prior therapy for AML (except hydroxycarbamide);

6. 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);

7. Renal function with creatinine clearance rate (Ccr) higher than 30 ml/min;

8. 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.

Exclusion Criteria:

1. Acute promyeloid leukemia;

2. AML with central nervous system (CNS) infiltration;

3. Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance) or gastrointestinal surgery;

4. HIV infection, Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment;

5. Severe and active infection that is difficult to control and cannot tolerate induction therapy;

6. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen;

7. Antibiotic exposure within 30 days before enrollment (carbapenems and/or tigecycline were not included, penicillin, cephalosporins and quinolones could be included)

8. Patients reject to participate in the study;

9. Patients with severe heart failure (grade 3-4) or patients deemed unsuitable for enrolment by the investigator.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Adult
• Gut Microbiota
• Infections
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• collection of biological samples and clinical data
blood and feces samples

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in immune cells of blood in patients with acute myeloid leukemia before, during and after induction therapy	Immunomicin performed on patients' blood to report the composition of immune cells in those patients	Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Secondary	Changes of gut permeability markers and microbial compounds of blood in patients with acute myeloid leukemia before, during and after induction therapy	ELISA (in pg/ml)	Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Secondary	Infection rate during induction therapy	Infection rate of patients with acute myeloid leukemia after two different 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.
Secondary	Rate of complete remission	Complete remission after one cycle of 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.
Secondary	Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0	CTCAE (common terminology criteria for adverse event version 4)	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.