Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure

Conditions
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Flumatinib, Chronic Myeloid Leukemia, Chronic Phase, Imatinib

Intervention / Treatment
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* Drug: Flumatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Diagnosis of CML-CP with Ph+. ECOG performance of 0-2. Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN. Treatment failure after imatinib at 3 or 6 months with BCR-ABL >10%. Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital. Exclusion Criteria: Previously documented T315I mutation. History of TKI treatments except of imatinib. History of undergone major surgery within 4 weeks. Patients unwilling or unable to comply with the protocol. Pregnant or breast-feeding patients. patients with other malignant tumor.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flumatinib<br> | Drug: Flumatinib<br>* 600 mg of Flumatinib orally daily for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flumatinib, CML-CP with Ph+