NCT07561892RecruitingPhase 4
Study of the Effectiveness and Safety of Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).
Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
Silibinin is the major active component of silymarin, a commonly used hepatoprotective agent. It stabilizes hepatocyte membranes, preserves cellular integrity, and accelerates DNA synthesis in liver cells. Clinically, it is widely used in the treatment of chronic persistent hepatitis, chronic active hepatitis, early-stage liver cirrhosis, and hepatotoxicity. Moreover, it has been reported to inhibit the growth and differentiation of various cancer cells, including hepatocellular carcinoma, prostate cancer, breast cancer, and cervical cancer. Based on these preclinical findings, we aim to evaluate the efficacy and safety of combining silybinin with the standard first-line idarubicin/daunorubicin-based regimen in the treatment of newly diagnosed acute leukemia(non-M3)in a clinical setting.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 Feb 2025
- Start date
- 1 Apr 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07561892
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 1 Apr 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other clinical trials within one month prior to screening;
Other illness
- History of other malignant tumors concurrently or previously diagnosed malignancies not under control;
- Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;
- Other uncontrolled diseases that the investigator considers inappropriate for inclusion;
- Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;
- History of liver cirrhosis, or current active liver disease or biliary disease;
- HIV-positive individuals;
- Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.
Other
- Pregnant or breastfeeding women;
Who the study is looking for
- Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia;
- Suitable for standard chemotherapy regimens containing idarubicin/daunorubicin;
- Patients with an expected survival time of at least 3 months as determined by the investigator;
- Voluntarily agree to participate in this study and sign the informed consent form.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.