A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Официальное название

Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study

Обзор

Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).

Подробное описание

The purpose of this study is to investigate the long-term efficacy and safety of Flumatinib versus Imatinib in newly diagnosed CML-CP patients to the provide the real world evidence for the clinical treatment of CML-CP in China.

The overall design is a multicenter, prospective, observational study. The study plans to enroll 2,400 newly diagnosed CML-CP subjects.The primary efficacy endpoint is the rate of major molecular response (MMR) , as measured by RQ-PCR at 12 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (A month is defined as 28 days)

Вмешательства

• Препарат Flumatinib
  Flumatinib 600mg orally daily
• Препарат Imatinib
  Imatinib 400mg orally daily (Reference drug instructions)

Первичные конечные точки

• Major molecular response (MMR) rate at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (7)

• MMR rate of high-risk population treated at the end of 12 months [Срок оценки: 12 months]
• MMR rate at 6, 24 and 36 Months [Срок оценки: 6, 24 and 36 Months]
• Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months [Срок оценки: 6, 12, 24 and 36 Months]
• Percentage of participants with transformation-free survival (TFS) [Срок оценки: up to 60 Months]
• Percentage of participants with progression free survival (PFS) [Срок оценки: up to 60 Months]
• Percentage of participants with overall survival (OS) [Срок оценки: up to 60 Months]
• Incidence and severity of adverse events (AE) [Срок оценки: From baseline until 28 days after the last dose]

Критерии участия

Критерии включения

• Men or women aged more than or equal to (≥) 18 years.
• Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
• Eastern Cooperative Oncology Group (ECOG) performance status: 0\~2.
• Signed and dated Informed Consent Form.

Критерии исключения

• Patients with previously documented T315I mutation.
• Received BCR-ABL TKI(s) treatment before enrollment.
• Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
• Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
• Pregnant or lactating female.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Institute of Hematology and Oncology, Harbin The First Hospital — Харбин

Идентификаторы

NCT: NCT05367765 · HS-10096-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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