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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collection of biological samples and clinical data | Other | blood and feces samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes of gut permeability markers and microbial compounds of blood in patients with acute myeloid leukemia before, during and after induction therapy |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suning Chen, professor | Contact | 8613814881746 | chensuning@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Suning Chen, professor | The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology | Suzhou | Jiangsu | 215000 | China |
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ELISA (in pg/ml) |
| 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 | 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 | 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) | 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. |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007239 | Infections |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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