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NCT Number: NCT07561892

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Meijuan Huang, MD

CONTACT

[email protected]

13365910912

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;
  • Pregnant or breastfeeding women;
  • History of liver cirrhosis, or current active liver disease or biliary disease;
  • HIV-positive individuals;
  • Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.

Treatment and study plan

daunomycin/Idarubicin+ Silybinin

Drug

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.

daunomycin/Idarubicin

Drug

The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days

Primary outcomes

  1. overall remission rate (ORR)

    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)

  2. overall survival (OS)

    Time frame: 1-year

    subjects survival after treatment are finished

Secondary outcomes

  1. Time to Response(TTR)

    Time frame: 1-2months(1-2 courses)

    The time from initiation of the study treatment to the first documentation of CR or PR.

  2. Duratin of Response(DOR)

    Time frame: 1-year

    The time from first documentation of CR to the first documented disease progression or death, whichever occurs first

  3. Progression-Free Survival(PFS)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Meijuan Huang

CONTACT

[email protected]

13365910912

Shuxia Zhang, MD

CONTACT

[email protected]

86-18006908855

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)

Acronym: AML

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

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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