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| Name | Class |
|---|---|
| Hainan General Hospital | OTHER |
| Sanya Central Hospital | UNKNOWN |
| First Affiliated Hospital of Shantou University Medical College | OTHER |
| Peking University Shenzhen Hospital |
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The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flumatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumatinib | Drug | 600 mg of Flumatinib orally daily for 24 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 percent. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with MR 4.0 at 3, 6, 9, 12 months. | Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent. | 3, 6, 9, 12 months. |
| Proportion of patients with MR 4.5 at 3, 6, 9, 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Du, Phd | Contact | 075583366388 | duxingz@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xin Du, Phd | Shenzhen Second People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Shenzhen | Recruiting | Shenzhen | Guangdong | 518035 | China |
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| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C553360 | flumatinib |
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| OTHER |
| Dongguan People's Hospital | OTHER_GOV |
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Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
| 3, 6, 9, 12 months. |
| Proportion of patients with MMR at 3, 6, 9 months. | 3, 6, 9 months |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib. | Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges. | 24 months |
| D009369 | Neoplasms |
| 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 |