CLAG+VEN vs CLAG in the Treatment of Relapsed/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: Cladribine, Cytarabine, G-CSF, Venetoclax.
- Кому может быть актуально
- Состояния в реестре: Relapsed/Refractory AML. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Multicenter, Prospective, Randomized Controlled Study Comparing the Efficacy and Safety of CLAG(Cladribine, Cytarabine and G-CSF) Combined With Venetoclax and CLAG in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Обзор
This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.
Подробное описание
The efficacy and prognosis of relapsed/refractory(r/r) AML are very poor, and there is no standard chemotherapy regimen were defined for r/r AML. Cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on AML cells. Previous studies have confirmed the efficacy of cladribine in the treatment of r/r AML, with a response rate of 30-45%.Our previous experience has shown that CLAG in combination of venetoclax are effective with tolerable toxicity profiling. However, there is a lack of multicenter, prospective, randomized controlled trials to further confirm the results. Therefore, a clinical study is planned to evaluate the efficacy and safety of CLAG+VEN compared to CLAG in r/r AML who were eligible for intensive therapy.
Вмешательства
- Препарат Cladribine
Given IV - Препарат Cytarabine
Given IV - Препарат G-CSF
Given SC - Препарат Venetoclax
Given PO
Первичные конечные точки
- Composite Complete remission (cCR, CR+CRi) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
Вторичные конечные точки (7)
- Overall Response rate (ORR) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
- MRDneg CR rate [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
- Overall Survival(OS) [Срок оценки: 1 year post treatment]
- Relapse free survival(RFS) [Срок оценки: 1 year post treatment]
- Duration of completed response(DoR) [Срок оценки: 1 year post treatment]
- Relapse rate [Срок оценки: 1 year post treatment]
- Incidence of Adverse Events [Срок оценки: Duration of treatment, up to 1 year]
Критерии участия
Критерии включения
- Diagnosed of AML according to the World Health Organization (WHO) classification.
- All patients should aged 18 to 65 years.
- Diagnosed of relapsed and refractory AML, according to The guidelines for diagnosis and treatment of relapse /refractory acute myelogenous leukemia in China（2023）
- Diagnostic criteria for relapsed AML: Leukemia cells reappear in the peripheral blood or primitive cells in the bone marrow ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) after CR, or leukemia cell infiltration appears outside the marrow.
- Diagnostic criteria for refractory AML: The newly diagnosed patients who failed to respond to two courses of standard treatment; Patients who relapsed within 12 months after consolidation intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.
- The score of Eastern Cooperative Oncology Group (ECOG) is 0-2.
- Renal function: creatinine clearance rate ≥ 30ml/min.
- Liver function: ALT<5 times normal value, bilirubin<3 times normal value.
- Predicted survival ≥ 3 months.
- Able to accept oral Venetoclax.
- Sign an informed consent form and be able to understand and follow the procedures required by this protocol.
Критерии исключения
- Diagnosed of acute promyelocytic leukemia (AML-M3)
- Patients with central nervous system (CNS) invasion.
- Cardiac function < grade 2.
- Known human immunodeficiency virus (HIV) infection.
- Other clinically significant uncontrolled conditions, including but not limited to: a. uncontrolled or active systemic infections (viruses, bacteria, or fungi); b. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; c. Secondary tumors requiring active treatment.
- Allergy to experimental drugs.
- Pregnant and lactating women.
- Patients who ineligible for the study according to the investigator's assessment.
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
- Department of Hematology,Nanfang Hospital, Southern Medical University — Гуанчжоу
Идентификаторы
NCT: NCT06763666 · NFEC-2024-639