Adding silibinin to standard daunorubicin or idarubicin therapy for newly diagnosed non‑M3 acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial compares standard induction chemotherapy using daunorubicin or idarubicin with or without added silibinin in adults with newly diagnosed non‑M3 acute myeloid leukemia. Participants receive standard anthracycline‑based regimens and are monitored for safety, liver effects, and treatment response. The protocol enrolls patients suitable for daunorubicin/idarubicin regimens and excludes those with uncontrolled comorbidities or recent participation in other trials. Outcomes will determine whether adding silibinin improves efficacy or reduces chemotherapy‑related hepatotoxicity in a clinical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia;
2. Suitable for standard chemotherapy regimens containing idarubicin/daunorubicin;
3. Patients with an expected survival time of at least 3 months as determined by the investigator;
4. Voluntarily agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. History of other malignant tumors concurrently or previously diagnosed malignancies not under control;
2. Participation in other clinical trials within one month prior to screening;
3. Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;
4. Other uncontrolled diseases that the investigator considers inappropriate for inclusion;
5. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;
6. Pregnant or breastfeeding women;
7. History of liver cirrhosis, or current active liver disease or biliary disease;
8. HIV-positive individuals;
9. Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Meijuan Huang
• Email: huangmj@fjmu.edu.cn
• Phone: 13365910912

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.