Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Location status: Recruiting
NCT Number: NCT07561892
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 4
Fuzhou, Fujian, 350001, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)
subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)
Time frame: 1-year
subjects survival after treatment are finished
Time frame: 1-2months(1-2 courses)
The time from initiation of the study treatment to the first documentation of CR or PR.
Time frame: 1-year
The time from first documentation of CR to the first documented disease progression or death, whichever occurs first
Time frame: 1-year
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
Contact information is provided by the study sponsor or research team.
Meijuan Huang
CONTACT
Shuxia Zhang, MD
CONTACT
Fujian Medical University Union Hospital
Other
Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)
Acronym: AML
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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