Clinical trial · Observational
Investigation of the Gut Microbiota in Acute Myeloid Leukemia Receiving Two Different Induction Therapies
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Adult | — | UNRESOLVED | — |
| Gut Microbiota | — | UNRESOLVED | — |
| Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| collection of biological samples and clinical data | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Standard intensive chemotherapy
- description
- 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).
- interventionNames
- Other: collection of biological samples and clinical data
- label
- Bcl-2 inhibitor-based targeted therapy
- description
- 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.
- interventionNames
- Other: collection of biological samples and clinical data
Primary outcomes (2)
- measure
- Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after induction therapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available