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

Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing 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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; Chemotherapy Effect; Newly Diagnosed
• Intervention / Treatment: Drug: daunomycin/Idarubicin+ Silybinin; Drug: daunomycin/Idarubicin

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Meijuan Huang; Phone Number: 13365910912; Email: huangmj@fjmu.edu.cn
• Study Contact Backup: Name: Shuxia Zhang, MD; Phone Number: 86-18006908855; Email: zhangshuxia235@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Meijuan Huang, MD; Phone Number: 13365910912; Email: huangmj@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia;
2. Suitable for standard chemotherapy regimens containing idarubicin/daunorubicin;
3. Patients with an expected survival time of at least 3 months as determined by the investigator;
4. Voluntarily agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. History of other malignant tumors concurrently or previously diagnosed malignancies not under control;
2. Participation in other clinical trials within one month prior to screening;
3. Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;
4. Other uncontrolled diseases that the investigator considers inappropriate for inclusion;
5. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;
6. Pregnant or breastfeeding women;
7. History of liver cirrhosis, or current active liver disease or biliary disease;
8. HIV-positive individuals;
9. Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: daunomycin/ Idarubicin + Silybinin treatment; 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.	Drug: daunomycin/Idarubicin+ Silybinin; 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.
Experimental: daunomycin/Idarubicin treatment; The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days	Drug: daunomycin/Idarubicin; The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	subjects survival after treatment are finished	1-year
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)	At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Response(TTR)	The time from initiation of the study treatment to the first documentation of CR or PR.	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	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	1-year

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Study Director: Yuanzhong Chen, MD, Fujian Institute of Haematology, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 2, 2025
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: AML; Idarubicin; newly diagnosed; daunorubicin; Silybin
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Idarubicin
• Other Study ID Numbers: FJ Depart of Hematology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No