Investigation of the Gut Microbiota in Acute Myeloid Leukemia Receiving Two Different Induction Therapies
NCT ID: NCT05123352
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2021-11-30
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
collection of biological samples and clinical data
blood and feces samples
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.
collection of biological samples and clinical data
blood and feces samples
Interventions
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collection of biological samples and clinical data
blood and feces samples
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Suning Chen, professor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Locations
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The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Other Identifiers
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AML-GutMicrobiota01
Identifier Type: -
Identifier Source: org_study_id