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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flumatinib | flumatinib 600mg QD, fasting administration |
| |
| nilotinib | nilotinib 300mg BID, fasting administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumatinib Mesylate | Drug | Flumatinib mesylate tablets 600mg qd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major molecular response rate at 12 months | Major molecular response is defined as ≤ 0.1% BCR-ABL/ABL% by international scale | 12 months |
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Inclusion Criteria:
4.Patients who must sign informed consent before screening
Exclusion Criteria:
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Newly diagnosed chronic-phase CML patients (CMP-CP) treated with flumatinib or Nilotinib
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suning Chen | Contact | 13814881746 | chensuning@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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| Nilotinib Pill |
| Drug |
Nilotinib Capsules 300mg bid |
|