Actively Recruiting
Study of the Effectiveness and Safety of Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).
Led by Fujian Medical University Union Hospital · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Effectiveness and Safety of Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute leukemia (non-M3) confirmed by 2018 WHO criteria
- Suitable for standard chemotherapy with idarubicin or daunorubicin
- Expected to live at least 3 months as judged by the investigator
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- History of other active or uncontrolled malignant tumors
- Participation in another clinical trial within 1 month before screening
- Uncontrolled cerebrovascular, coagulation, connective tissue, or similar diseases
- Other uncontrolled diseases deemed inappropriate by the investigator
- Psychiatric disorders or inability to comply fully with the study
- Pregnant or breastfeeding women
- History of liver cirrhosis or current active liver or biliary disease
- HIV positive
- Any condition that may prevent study completion or pose significant risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
M
Meijuan Huang
CONTACT
S
Shuxia Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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