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Chronic myeloid leukemia (CML) is a malignant disease of acquired hematopoietic stem cells. The BCR-ABL fusion gene is the pathogenic basis of CML. Tyrosine kinase inhibitors (TKIs) are targeted drugs for this fusion protein. With the wide clinical application of TKIs, the efficacy of CML patients has been greatly improved. However, there are still a significant number of patients who have poor response to the first generation of TKI drugs, imatinib, most of them have early molecular response failures (BCR-ABL(IS)>10% at 3 or 6 months) ,which means lower rates of molecular response, increased risk of progression, and higher overall survival. For them, the early conversion of dasatinib might be a better choice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib group |
| ||
| Imatinib group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib 100 MG | Drug | The CML-CP patients with early(3m to 6m) molecular response failure on imatinib,Conversion dasatinib group or Imatinib group |
|
| Measure | Description | Time Frame |
|---|---|---|
| MMR in 1 year | MMR(BCR/ABL(IS)<0.1%) at 12 months after switching to dasatinib for patients who did not achieve optimal treatment with imatinib for 3 to 6 months. | 1 year |
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Inclusion Criteria:
1.18-65 years old; 2.CML-CP,and Imatinib treatment longest for 6 months ; 3.Q-pcr monitoring of BCR/ABLIS failed to achieve the best therapeutic effect(BCR/ABLIS>10.00% in 3m or BCR/ABLIS>1.00% in 6m); 4.No previous history of malignant tumor; 5.Informed consent of the patient or his legal representative
Exclusion Criteria:
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CML-CP patients treated with imatinib failed to achieve the best therapeutic effect(BCR/ABLIS>10.00% in 3m or BCR/ABLIS>1.00% in 6m)convert to dasatinib.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NanfangH | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |