Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia

Официальное название

Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia：A Multicenter, Randomized, Controlled, Phase 3 Trial

Обзор

This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.

Вмешательства

• Препарат the standard "3+7" regimen
  IA Regimen: Idarubicin: 8-12 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.
• Препарат Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
  IA Regimen: Idarubicin: 8-12 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.

Первичные конечные точки

• Composite Complete Remission (CRc) Rate after 1 course of treatment [Срок оценки: 1 months after study treatment]

Вторичные конечные точки (9)

• Overall Response Rate (ORR) after 1 course of treatment [Срок оценки: 1 months after the start of study treatment]
• Complete Remission (CR) Rate after 1 courses of treatment [Срок оценки: after 1 courses of chemotherapy (each course is 28 days)]
• Rate of Minimal Residual Disease (MRD)-Negative Response [Срок оценки: after each courses of chemotherapy (each course is 28 days)]
• Event-free survival [Срок оценки: 180 days after study treatment]
• Overall Survival [Срок оценки: 180 days after study treatment]
• Treatment-related adverse events [Срок оценки: From the first dose of study treatment to 30 days after the discontinuation of treatment]
• Disease-free survival [Срок оценки: 180 days after study treatment Outcome Measure]
• Early death [Срок оценки: Within 30 days of the start of the first course of treatment]
• Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment [Срок оценки: after 1 courses of chemotherapy (each course is 28 days]

Критерии участия

Критерии включения

• Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;
• Age between 60-75 years at the time of screening, with no gender restrictions;
• Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;
• No severe allergic constitution;
• Liver function: ALT and AST <= 2.5 times the upper limit of normal values, bilirubin <= 2 times the upper limit of normal values;
• Renal function: creatinine <= upper limit of normal values;
• No uncontrollable infections or severe mental illnesses;
• Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.

Критерии исключения

• Patients who are allergic to the study medication or have contraindications to it;
• Pregnant or breastfeeding women;
• Patients with active infections;
• Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;
• Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;
• Patients who have undergone major organ surgery within the last 6 weeks;
• Abnormal liver function, with total bilirubin > 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT/AST > 5 times the upper limit of normal; abnormal renal function, with serum creatinine > 1.5 times the upper limit of normal;
• Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).

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

• Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07514936 · KY-2024-9-140-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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