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Идёт набор NCT07028086

VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma

Фаза II С лечением Acute Myeloid Leukemia Myeloid Sarcoma

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: VAM_GROUP.
Кому может быть актуально
Состояния в реестре: Acute Myeloid Leukemia, Myeloid Sarcoma. Базовые параметры: 18 лет — 65 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

Prospective, Multicenter, Single-Arm Clinical Study of Mitoxantrone Liposome Combined With Azacitidine and Venetoclax in the Treatment of Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma

Обзор

The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity. Building upon this, the investigators aim to investigate the efficacy and safety of the liposomal mitoxantrone hydrochloride injection in patients with secondary AML, AML with extramedullary involvement, or myeloid sarcoma, in order to explore alternative therapeutic strategies for these populations.

Вмешательства

  • Препарат VAM_GROUP
    Mitoxantrone Liposome 24mg/m², IV, administered as a single dose or divided doses at the investigator's discretion based on the patient's condition; Azacitidine 75mg/m², IV drip, Day 1 to Day 7; Venetoclax 100mg on Day 1, 200mg on Day 2, and 400mg on Day 3 to Day 14.

Первичные конечные точки

  • Composite Complete Remission Rate [Срок оценки: After completing two cycles (each cycle is 28 days) of VAM therapy]
Вторичные конечные точки (3)
  • Event-Free Survival [Срок оценки: from data of AML diagnosis until the data of events, assessed up to 2 years]
  • Overall Survival [Срок оценки: from enrollment to study completion, a maximum of 2 years]
  • Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: During the two cycles (each cycle is 28 days) of VAM therapy and follow-up for 2 years after completion]

Критерии участия

Критерии включения

  • The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
  • Age 18-65 years
  • Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with extramedullary/myeloid sarcoma; d. Age ≥60 years, assessed as fit-AML;
  • Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
  • Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN
  • Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2

Критерии исключения

  • Assessed as unfit- or frail-AML;
  • Patients with a history or concurrent diagnosis of other malignancies requiring treatment
  • Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
  • Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
  • Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
  • Patients with a history of severe neurological or psychiatric disorders
  • Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
  • Cerebrovascular events (including transient ischemic attacks), etc.
  • Known infection with human immunodeficiency virus (HIV); active hepatitis B or C infection; inactive hepatitis carriers or subjects with low viral titers after receiving non-prohibited antiviral therapy are not excluded
  • Subjects who have received strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment
  • Patients unable to take oral medications or with malabsorption syndrome
  • Patients deemed by the investigator to be unsuitable for participation in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07028086 · MAVEN_01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗