Compares flumatinib with imatinib as first treatment for chronic myeloid leukemia
Compares flumatinib and imatinib in adults newly diagnosed with chronic myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Key facts
- Where
- Harbin, ChinaSee the site
- Phase
- Phase 4
Where in China
- Institute of Hematology and Oncology, Harbin The First HospitalHarbin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT05367765
- Record updated
- 10 May 2022
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: 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.