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Идёт набор NCT05404906

AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Фаза II / Фаза III С лечением Acute Myeloid Leukemia (AML) in Remission

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: Azacitidine, Venetoclax, Supportive care.
Кому может быть актуально
Состояния в реестре: Acute Myeloid Leukemia (AML) in Remission. Базовые параметры: 18 лет — 64 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

Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy

Обзор

This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.

Вмешательства

  • Препарат Azacitidine
    Given SC
  • Препарат Venetoclax
    Given PO
  • Другое Supportive care
    Patients will receive disease monitoring and supportive care for any complication.

Первичные конечные точки

  • Relapse-free survival (RFS) [Срок оценки: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years]
Вторичные конечные точки (5)
  • Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion [Срок оценки: Measured From Baseline to approximately 3 years]
  • Complete remission duration (CRd) [Срок оценки: From date of CR/CRi to approximately 3 years]
  • Overall Survival (OS) [Срок оценки: Time from treatment to death from any cause, up to approximately 3 years]
  • Event free survival (EFS) [Срок оценки: Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years]
  • Incidence of adverse events [Срок оценки: Time from treatment to approximately 3 years]

Критерии участия

Критерии включения

  • Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.
  • Aged 18-64 years.
  • Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
  • ECOG performance status of < or = 3.
  • Adequate organ function as follows:
  • Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN)
  • Aspartate Transaminase and alanine transaminase < or = to 3 x ULN
  • Ccr（Creatinine Clearance Rate) > or ＝60 ml/min
  • Left ventricular ejection fraction > or ＝50% determined by ultrasound.
  • For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
  • For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
  • Ability to understand and sign informed consent.

Критерии исключения

  • Acute promyeloid leukemia.
  • Patients with active central nervous system (CNS) leukemia.
  • Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
  • Patients with other progressive malignancies.
  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
  • Patients who have participated in other trials within 30 days before signing the informed consent.
  • Females who are pregnant or lactating or intending to become pregnant during the study.

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 · 2 центра
  • First Affiliated Hospital of Soochow University — Сучжоу
  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology — Сучжоу

Идентификаторы

NCT: NCT05404906 · SZ-AML124

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗