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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• overall remission rate (ORR) [Срок оценки: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)]
• overall survival (OS) [Срок оценки: 1-year]

Вторичные конечные точки (3)

• Time to Response(TTR) [Срок оценки: 1-2months(1-2 courses）]
• Duratin of Response(DOR) [Срок оценки: 1-year]
• Progression-Free Survival(PFS) [Срок оценки: 1-year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fujian Medical University Union Hospital — Фучжоу

Идентификаторы

NCT: NCT07561892 · FJ Depart of Hematology

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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