Silibinin added to chemotherapy for newly diagnosed acute myeloid leukemia
Tests silibinin added to chemotherapy in adults with new acute myeloid leukemia.
Key facts
- Who runs it
- Fujian Medical University Union Hospital
- Where
- Fuzhou, ChinaSee the site
- Trial code
- Registry title
- Study of the Effectiveness and Safety of Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 100 people, planned
- Started
- 1 Apr 2022
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- daunomycin/Idarubicin+ Silybinin
- daunomycin/Idarubicin
- Record updated
- 1 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with newly diagnosed acute myeloid leukemia (not the M3 type) who can have standard chemotherapy with idarubicin or daunorubicin. It tests adding silibinin.
- Age
- 18 Years to 65 Years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed acute leukemia (non-M3), confirmed by the 2018 WHO classification.
- Earlier treatment
- No earlier treatment is named, but the person must be able to have standard chemotherapy with idarubicin/daunorubicin. Taking part in another clinical trial within one month before screening is not allowed.
Main reasons for not taking part
- Another cancer that is not under control
- Uncontrolled brain blood vessel disease, clotting problems or connective tissue disease
- Liver cirrhosis, active liver disease or bile duct disease
- HIV-positive
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participation in other clinical trials within one month prior to screening
- 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
- Pregnant or breastfeeding women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in China
- Fujian Medical University Union HospitalFuzhou, ChinaContact: Meijuan Huang, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- daunomycin/ Idarubicin + Silybinin treatmentTreatment being tested
The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days, at the same time, Silybin 200mg tid is administrated.
Treatment: daunomycin/Idarubicin+ Silybinin
- daunomycin/Idarubicin treatmentTreatment being tested
The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days
Treatment: daunomycin/Idarubicin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)
- Plain-language title
- Silibinin added to chemotherapy for newly diagnosed acute myeloid leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07561892, who can take part
- Record updated
- 1 May 2026