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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGoverall 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)
Time frame: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)
overall survival (OS)
subjects survival after treatment are finished
Time frame: 1-year
Time to Response(TTR)
The time from initiation of the study treatment to the first documentation of CR or PR.
Time frame: 1-2months(1-2 courses)
Duratin of Response(DOR)
The time from first documentation of CR to the first documented disease progression or death, whichever occurs first
Time frame: 1-year
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
Time frame: 1-year
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