A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study

Conditions
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CML, Chronic Phase

Intervention / Treatment
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* Drug: Flumatinib
* Drug: Imatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged more than or equal to (≥) 18 years. Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis.. Eastern Cooperative Oncology Group (ECOG) performance status: 0 2. Signed and dated Informed Consent Form. Exclusion Criteria: Patients with previously documented T315I mutation. Received BCR-ABL TKI(s) treatment before enrollment. Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment Participated in other clinical trials that might affect the efficacy and safety of CML during this study. Pregnant or lactating female.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flumatinib mesylate tablets<br> | Drug: Flumatinib<br>* Flumatinib 600mg orally daily<br>|
| Active Comparator: Imatinib mesylate tablets<br> | Drug: Imatinib<br>* Imatinib 400mg orally daily (Reference drug instructions)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMR rate of high-risk population treated at the end of 12 months | High-risk population：Sokal score>1.2 MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR. | 12 months | 
| MMR rate at 6, 24 and 36 Months | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Myeloid Leukemia, Flumatinib, BCR-ABL TKI, Real World, Prospective