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.
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.
History of other malignant tumors concurrently or previously diagnosed malignancies not under control;
Participation in other clinical trials within one month prior to screening;
Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;
Other uncontrolled diseases that the investigator considers inappropriate for inclusion;
Parallel
daunomycin/Idarubicin+ Silybinin
DrugThe chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days, at the same time, Silybin 200mg tid is administrated.
daunomycin/Idarubicin
DrugThe chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days
overall remission rate (ORR)
subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)
overall survival (OS)
subjects survival after treatment are finished
Time to Response(TTR)
The time from initiation of the study treatment to the first documentation of CR or PR.
Duratin of Response(DOR)
The time from first documentation of CR to the first documented disease progression or death, whichever occurs first
Progression-Free Survival(PFS)
The time interval from the start of the study treatment to the first documentation of disease progression or death from any cause,whichever occurs first
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