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Идёт набор NCT06737523

Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML

Фаза I С лечением Acute Myeloid Leukemia Relapse Refractory 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: CVA.
Кому может быть актуально
Состояния в реестре: Acute Myeloid Leukemia, Relapse, Refractory 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Prospective, Single-arm Clinical Study of Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of Refractory/Relapsed Acute Myeloid Leukemia (R/R AML)

Обзор

To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory/relapsed acute myeloid leukemia (R/R AML).

Подробное описание

1. Sogletanib 48mg per dose, once daily; Venetoclax 400mg per dose, once daily for 4 weeks; Azacitidine 100mg, once daily, days 1-7. 28 days/cycle, at least 2 cycles. 2. The drug concentration of Venetoclax will be tested one week after oral administration, and the dose will be adjusted according to the concentration. 3. After 2 treatment courses, patients with stable disease (SD) or progressive disease (PD) may receive up to 1-2 additional courses. If the disease still shows no improvement, they will be withdrawn from the clinical study and other treatment options will be considered, including allogeneic hematopoietic stem cell transplantation.

Note: In special circumstances based on the patient's condition, laboratory test indicators, and adverse reactions, etc.; for Venetoclax dosage, if the white blood cell count is \>25×10\^9/L before administration, hydroxyurea may be given first to reduce the count to less than 25×10\^9/L before adding Venetoclax, and then the concentration of Venetoclax will be tested and the dose adjusted according to the concentration.

Вмешательства

  • Препарат CVA
    Chiglitazar Sodium in combination with Venetoclax and Azacitidine

Первичные конечные точки

  • Complete remission rate (CR) [Срок оценки: Up to 36 months]
  • Complete Remission with Incomplete Count Recovery (CRi) [Срок оценки: Up to 36 months]
  • Partial remission rate (PR) [Срок оценки: Up to 36 months]

Критерии участия

Критерии включения

  • Acute myeloid leukemia (AML) confirmed by histology. Relapsed or refractory AML, including: a) Refractory disease is defined as no remission after at least one prior treatment. b) Disease relapse is defined as 5% or more blasts in the bone marrow after remission. c) Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, t-AML) are also eligible;
  • Age ≥18 years, male or female, with an expected survival of more than 3 months;
  • Estimated creatinine clearance ≥ 50 mL/min;
  • AST and ALT ≤ 3.0 x ULN (unless considered due to leukemia organ involvement), bilirubin ≤ 3.0 x ULN (unless considered due to leukemia organ involvement);
  • ECOG ≤ 2;
  • Subjects are non-pregnant or using contraceptive measures during treatment;
  • Capable of understanding and voluntarily providing informed consent.

Критерии исключения

  • Acute promyelocytic leukemia (APL);
  • Active central nervous system leukemia;
  • Patients with clinically significant QTc interval prolongation (males > 450 ms; females > 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, history of myocardial infarction and congestive heart failure within the year prior to enrollment, and patients with clinically symptomatic coronary heart disease requiring medication;
  • Active, uncontrolled severe infection;
  • Other non-myeloid malignancies within the past 2 years;
  • Mental disorders that would impede study participation;
  • Previous solid organ transplantation (pre-treatment with SCT is allowed, but not allowed if the patient has GVHD or is still receiving immunosuppressive/GVHD treatment);
  • Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial.

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
  • The First Affiliated Hospital of Xiamen University — Xiamen

Идентификаторы

NCT: NCT06737523 · XMDYYYXYK-15

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗