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The purpose of this study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of 70mg dasatinib by measuring rates of major molecular response (MMR) at 12 months in patients with CML-CP in China. Approximately 65 Patients will be recruited consecutively from the study sites during the enrollment period and will be given dasatinib 70 mg QD. The duration of patient participation will be 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib 70 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | 70 mg of Dasatinib orally daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test | Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1% | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with MR 4.0 at 12 months. | Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01% | 12 months |
| Proportion of patients with MR 4.5 at 12 months. | Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032% |
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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 |
|---|---|---|---|---|---|---|
| Xin Du | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 12 months |
| Proportion of patients with Complete cytogenetic response (CCyR) at 12 months | defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1% | 12 months |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib | Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges | 18 months |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |