Идёт набор NCT06051409
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
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: Olverembatinib, Investigator's choice of TKI.
- Кому может быть актуально
- Состояния в реестре: Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive. 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
- США, Австралия, Китай, Чехия, Франция +7
- 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 Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL
Обзор
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
Подробное описание
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
Вмешательства
- Препарат Olverembatinib
Oral (PO) once every other day (QOD). - Препарат Investigator's choice of TKI
Oral (PO) once daily (QD).
Первичные конечные точки
- Minimal Residual Disease Negative CR Rate [Срок оценки: Cycle 1 to Cycle 3 (each cycle is 28 days)]
Вторичные конечные точки (4)
- Event-free Survival (EFS) [Срок оценки: Baseline up to 3 to 6 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. [Срок оценки: Through study completion (approximately 2 years)]
- Plasma concentrations of olverembatinib [Срок оценки: Cycle 1 to Cycle 3 (each cycle is 28 days)]
- FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score [Срок оценки: Through study completion (approximately 2 years)]
Критерии участия
Критерии включения
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Adequate organ function
Критерии исключения
- A history of chronic myeloid leukemia (CML)
- Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
- Previous or current clinical CNS diseases
- Autoimmune diseases that may involve the CNS
- Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
- Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug
- Uncontrolled heart diseases
- Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism
- Use of prohibited drugs
- Disease or medical condition that is unstable or may affect its safety or compliance with the study
- Use of medications known to cause prolonged QT interval
- Active infections requiring systemic treatment
- Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
- Contraindications to the use of glucocorticoids
- Bleeding disorders unrelated to ALL
- Plan to undergo major surgery
- Allergy to drug ingredients, excipients, or their analogues in the study
- Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period
- Other malignant tumors within 2 years
- Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate 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
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 16 центров
- Ascentage Investigative Site #1044 — Birmingham
- Ascentage Investigative Site #1062 — Duarte
- Ascentage Investigative Site #1134 — Los Angeles
- Ascentage Investigative Site #1059 — Los Angeles
- Ascentage Investigative Site #1142 — Miami
- Ascentage Investigative Site #1045 — Augusta
- Ascentage Investigative Site #1158 — Indianapolis
- Ascentage Investigative Site #1069 — Indianapolis
- … и ещё 8 центров
Испания · 12 центров
- Ascentage Investigative Site #6018 — Badalona
- Ascentage Investigative Site #6019 — Badalona
- Ascentage Investigative Site #6020 — Barcelona
- Ascentage Investigative Site #6048 — Cáceres
- Ascentage Investigative Site #6016 — Madrid
- Ascentage Investigative Site #6049 — Madrid
- Ascentage Investigative Site #6035 — Madrid
- Ascentage Investigative Site #6013 — Madrid
- … и ещё 4 центра
Turkey (Türkiye) · 11 центров
- Ascentage Investigative Site #9201 — Ankara
- Ascentage Investigative Site #9204 — Ankara
- Ascentage Investigative Site #9212 — Ankara
- Ascentage Investigative Site #9209 — Ankara
- … и ещё 7 центров
Китай · 10 центров
- The First Affiliated Hospital of Bengbu Medical School — Bengbu
- Xinqiao Hospital of Army Medical University — Чунцин
- Guangdong Province People's Hospital — Guangdong
- Nanfang Hospital of Southern Medical University — Guangdong
- Henan Cancer Hospital — Чжэнчжоу
- Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Techn — Ухань
- The First Affiliated Hospital of Suzhou University — Сучжоу
- Shanghai Jiao Tong University School of Medicine Ruijin Hospital — Шанхай
- … и ещё 2 центра
Франция · 8 центров
- Ascentage Investigative Site #5020 — Le Chesnay
- Ascentage Investigative Site #5021 — Lyon
- Ascentage Investigative Site #5013 — Nantes
- Ascentage Investigative Site #5025 — Nice
- Ascentage Investigative Site #5019 — Pessac
- Ascentage Investigative Site #5024 — Pierre-Bénite
- Ascentage Investigative Site #5022 — Poitiers
- Ascentage Investigative Site #5018 — Toulouse
Италия · 8 центров
- Ascentage Investigative Site #5538 — Bologna
- Ascentage Investigative Site #5529 — Meldola
- Ascentage Investigative Site #5539 — Milan
- Ascentage Investigative Site #5533 — Monza
- Ascentage Investigative Site #5540 — Ravenna
- Ascentage Investigative Site #5531 — Roma
- Ascentage Investigative Site #5550 — Torino
- Ascentage Investigative Site #5536 — Varese
South Korea · 6 центров
- Ascentage Investigative Site #8206 — Busan
- Ascentage Investigative Site #8207 — Busan
- Ascentage Investigative Site #8201 — Seoul
- Ascentage Investigative Site #8202 — Seoul
- Ascentage Investigative Site #8203 — Seoul
- Ascentage Investigative Site #8208 — Uijeongbu-si
Чехия · 5 центров
- Ascentage Investigative Site #8647 — Brno
- Ascentage Investigative Site #6305 — Hradec Králové
- Ascentage Investigative Site #6304 — Ostrava
- Ascentage Investigative Site #6302 — Prague
- Ascentage Investigative Site #6309 — Prague
Австралия · 4 центра
- Royal North Shore Hospital — St Leonards
- Royal Adelaide Hospital — Adelaide
- Alfred Health — Melbourne
- Royal Perth Hospital — Perth
Румыния · 4 центра
- Ascentage Investigative Site #6503 — Bucharest
- Ascentage Investigative Site #6502 — Cluj-Napoca
- Ascentage Investigative Site #6507 — Craiova
- Ascentage Investigative Site #6504 — Iași
Сингапур · 3 центра
- Ascentage Investigative Site #6602 — Singapore
- Ascentage Investigative Site #6603 — Singapore
- Ascentage Investigative Site #6604 — Singapore
Великобритания · 3 центра
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06051409 · HQP1351AG301