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 \[standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy\].
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.
Study Type
OBSERVATIONAL
Enrollment
60
blood and feces samples
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
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
Time frame: 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
Time frame: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
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
Time frame: 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
ELISA (in pg/ml)
Time frame: Day 0 i.e.: blood sampling is done at time of diagnosis before induction therapy
Infection rate during induction therapy
Infection rate of patients with acute myeloid leukemia after two different induction therapy
Time frame: 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
Complete remission after one cycle of induction therapy
Time frame: 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
CTCAE (common terminology criteria for adverse event version 4)
Time frame: 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.
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