Study of Safety and Effectiveness of Daunorubicin or Idarubicin With or Without Silibinin in Treating Newly Diagnosed Acute Myeloid Leukemia Non-M3

What this Trial Is About

Researchers are studying the use of silibinin, a major active component of silymarin known for protecting the liver and potentially inhibiting the growth of various cancer cells, combined with standard chemotherapy drugs idarubicin or daunorubicin. This study focuses on patients who have newly diagnosed acute leukemia non-M3 type to evaluate the safety and effectiveness of adding silibinin to the usual treatment. Participants will receive one of two treatments standard chemotherapy using daunorubicin or idarubicin for three days, or the same chemotherapy combined with silibinin taken three times daily. The chemotherapy dosage is daunorubicin 60 mgm2day or idarubicin 10 mgm2day, and silibinin is given at 200 mg three times a day alongside chemotherapy. This is a randomized study comparing these two treatment approaches. During the study, participants will be monitored for overall remission rates at the end of the first cycle and after 12 cycles of treatment, each lasting one month. Researchers will also track overall survival at one year, time to response, duration of response, and progression-free survival. Safety and compliance will be assessed throughout the study, which includes follow-up evaluations up to one year after treatment. The study is sponsored by Fujian Medical University Union Hospital and includes adults aged 18 to 65 years.

Study of the Effectiveness and Safety of Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).