Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).
The purpose of this study is to investigate the long-term efficacy and safety of Flumatinib versus Imatinib in newly diagnosed CML-CP patients to the provide the real world evidence for the clinical treatment of CML-CP in China.
The overall design is a multicenter, prospective, observational study. The study plans to enroll 2,400 newly diagnosed CML-CP subjects.The primary efficacy endpoint is the rate of major molecular response (MMR) , as measured by RQ-PCR at 12 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (A month is defined as 28 days)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flumatinib mesylate tablets | Experimental |
| |
| Imatinib mesylate tablets | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumatinib | Drug | Flumatinib 600mg orally daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major molecular response (MMR) rate at 12 months | MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MMR rate of high-risk population treated at the end of 12 months |
| 12 months |
| MMR rate at 6, 24 and 36 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Ma | Contact | 13304518000 | majun0322@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Ma | Institute of Hematology and Oncology, Harbin The First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Oncology, Harbin The First Hospital | Harbin | Heilongjiang | 201203 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Imatinib |
| Drug |
Imatinib 400mg orally daily (Reference drug instructions) |
|
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.
| 6, 24 and 36 Months |
| Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months | Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample. CCyR is defined as 0% Ph+ metaphases in the bone marrow. | 6, 12, 24 and 36 Months |
| Percentage of participants with transformation-free survival (TFS) | TFS was defined as the time between the first dose and the date of transition to AP/BP or the last efficacy assessment during treatment. | up to 60 Months |
| Percentage of participants with progression free survival (PFS) | PFS is defined as the time from the first dose to the date of earliest transition to AP/BC, or the date of death from any cause. | up to 60 Months |
| Percentage of participants with overall survival (OS) | OS was defined as the time between the first dose and the date of death from any cause. | up to 60 Months |
| Incidence and severity of adverse events (AE) | Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0. | From baseline until 28 days after the last dose |
| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C553360 | flumatinib |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided