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Идёт набор NCT05586074

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

Фаза III С лечением Leukemia, Acute Myeloid (AML)

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: Clifutinib, LoDAC, Azacitidine, Decitabine.
Кому может быть актуально
Состояния в реестре: Leukemia, Acute Myeloid (AML). Базовые параметры: от 18 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

HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial

Обзор

A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.

Подробное описание

Subjects who are at least 18 years and above at the time of signing informed consent may participate in this study. Subjects will be randomized in a 2:1 ratio to receive Clifutinib or salvage chemotherapy. Subjects will enter the screening period up to 28 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subjects; options will include low-dose cytarabine (LoDAC), azacitidine, decitabine, Ara-C±IDA or FLAG±IDA. The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles.

After treatment discontinuation, participants will have a end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety. After that, long term follow-up will be done every 90 days.

Вмешательства

  • Препарат Clifutinib
    tablet, oral
  • Препарат LoDAC
    subcutaneous (SC) or intravenous (IV) injection
  • Препарат Azacitidine
    SC or IV
  • Препарат Decitabine
    IV
  • Препарат Ara-C±IDA
    SC and IV
  • Препарат FLAG-IDA
    SC and IV

Первичные конечные точки

  • OS [Срок оценки: From the date of randomization until the date of death from any cause, assessed up to 5 years]
  • CR/CRh rate [Срок оценки: From randomization until the data cut-off date of April 2025, all subjects included in the primary analysis of CR/CRh rate were followed up at least 4 months]
Вторичные конечные точки (4)
  • EFS [Срок оценки: From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months]
  • CR rate [Срок оценки: From randomization until the data cut-off date of June 2026, all subjects included in the analysis of CR rate were followed up at least 4 months]
  • CRc Rate [Срок оценки: From randomization until the data cut-off date of June 2026, all subjects included in the analysis of CRc rate were followed up at least 4 months]
  • Adverse Events [Срок оценки: From ICF signature date up to 30 days after the last dose of study drug, median treatment duration for Clifutinib was 140 days versus salvage chemotherapy 140 days]

Критерии участия

Критерии включения

  • Subject is ≥ 18 years of age at the time of obtaining informed consent.
  • Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification;
  • Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant )
  • Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion

Критерии исключения

  • Subject has received prior treatment with other FLT3 inhibitors
  • Subject has AML that has relapsed after or is refractory to more than 1 line of therapy
  • Subject has an active uncontrolled infection
  • Subject is known to have human immunodeficiency virus infection
  • Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation

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
  • the First Affiliated Hospital,College of Medicine,Zhejiang University — Hanzhou

Идентификаторы

NCT: NCT05586074 · HEC73543-AML-301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗