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Идёт набор NCT06928376

A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients

Фаза II С лечением Acute Myeloid Leukemia First Line Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor, "3+7".
Кому может быть актуально
Состояния в реестре: Acute Myeloid Leukemia, First Line Therapy. Базовые параметры: 14 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Multicenter, Prospective, Randomized Controlled Study of the Standard "3+7" Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia

Обзор

The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).

Подробное описание

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia.

Вмешательства

  • Препарат Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
    Azacytidine (75 mg/m2/day, days 1 to 7). Cytarabine (75-100 mg/m2 bid, days 1 to 5). Aclacinomycin(20 mg/day, days 1,3,5). Chidamide (30 mg/day , days 1,4,8,11). Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
  • Препарат "3+7"
    IA regimen: Idarubicin (8-10 mg/m2) for 3 days . Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: Daunorubicin(60 mg/m2) for 3 days. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.

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]
  • 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

Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution

Критерии исключения

Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST > 2.5 times upper limit of normal; bilirubin > 2 times upper limit of normal Renal function: creatinine > upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)

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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: NCT06928376 · KY-2024-3-40-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗