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

NCT07561892 | Recruiting Phase 4

• 1 other identifier: FJ Depart of Hematology
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia; Newly Diagnosed; Chemotherapy Effect

Keywords

AML; newly diagnosed; Silybin; daunorubicin; Idarubicin

Outcome Measures

Primary Outcomes (2)

• 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)

• overall survival (OS)

  subjects survival after treatment are finished

  1-year

Secondary Outcomes (3)

• Time to Response(TTR)

  1-2months(1-2 courses）

• Duratin of Response(DOR)

  1-year

• Progression-Free Survival(PFS)

  1-year

Study Arms (2)

daunomycin/ Idarubicin + Silybinin treatment

EXPERIMENTAL

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

daunomycin/Idarubicin treatment

EXPERIMENTAL

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

Drug: daunomycin/Idarubicin

Interventions

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 + Silybinin treatment

daunomycin/Idarubicin DRUG

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

daunomycin/Idarubicin treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Daunorubicin; Idarubicin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Yuanzhong Chen, MD

  Fujian Institute of Haematology, Fujian Medical University Union Hospital

  STUDY DIRECTOR

Central Study Contacts

Meijuan Huang

CONTACT

13365910912; huangmj@fjmu.edu.cn

Shuxia Zhang, MD

CONTACT

86-18006908855; zhangshuxia235@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: May 1, 2026
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)