Evaluating Efficacy and Safety of Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia(CML-CP) : A Multicenter, Open-lable, Real World Study
The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.
⁃ Male or female patients ≥18 years of age;
⁃ CML-CP patients diagnosed with CML within half a year；Patients who have been using second-generation TKI nilotinib or flumatinib for first-line treatment in clinical practice, but the history of continuous treatment does not exceed 3 months；3.patients are allowed to receive hydroxyurea treatment before first-line treatment with nilotinib or flumartinib; patients treated with interferon for no more than 3 months and other TKIs for no more than 2 weeks;
• Patients who must sign informed consent before screening