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The purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flumatinib | Active Comparator | 600mg QD orally form 1 to 12 months |
|
| Dasatinib | Placebo Comparator | 100mg QD orally form 1 to 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumatinib | Drug | Flumatinib 600mg QD orally form 1 to 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy. | 12 months | |
| Time to optimal imatinib-related adverse event improvement. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Du | Contact | 075583366388 | duxingz@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | 518035 | China |
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| Dasatinib |
| Drug |
Dasatinib 100mg QD orally form 1 to 12 months |
|
| ID | Term |
|---|---|
| C553360 | flumatinib |
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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