Adding silibinin to standard daunorubicin or idarubicin therapy for newly diagnosed non‑M3 acute myeloid leukemia
Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)
This trial will test whether adding silibinin (a liver‑protecting compound) to standard daunorubicin or idarubicin chemotherapy helps people with newly diagnosed non‑M3 acute myeloid leukemia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07561892 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with newly diagnosed non‑M3 acute myeloid leukemia who are candidates for standard daunorubicin‑ or idarubicin‑based chemotherapy and can provide informed consent.
Not a fit: Patients with uncontrolled other malignancies, serious comorbidities (such as uncontrolled cerebrovascular disease or coagulation disorders), psychiatric conditions preventing protocol compliance, or inability to attend the study site may not receive benefit.
Why it matters
Potential benefit: If successful, adding silibinin could improve treatment effectiveness or reduce chemotherapy‑related liver toxicity for patients receiving anthracycline induction.
How similar studies have performed: Silibinin is commonly used for hepatoprotection and shows anticancer effects in preclinical studies, but its addition to anthracycline regimens in newly diagnosed AML has limited clinical trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Meijuan Huang
- Email: huangmj@fjmu.edu.cn
- Phone: 13365910912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.