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Recruiting NCT07561892

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

Phase IV Interventional Acute Myeloid Leukemia Newly Diagnosed Chemotherapy Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: daunomycin/Idarubicin+ Silybinin, daunomycin/Idarubicin.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Newly Diagnosed, Chemotherapy Effect. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • overall remission rate (ORR) [Time frame: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)]
  • overall survival (OS) [Time frame: 1-year]
Secondary outcome measures (3)
  • Time to Response(TTR) [Time frame: 1-2months(1-2 courses）]
  • Duratin of Response(DOR) [Time frame: 1-year]
  • Progression-Free Survival(PFS) [Time frame: 1-year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian Medical University Union Hospital — Fuzhou

Identifiers

NCT: NCT07561892 · FJ Depart of Hematology

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗