The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients

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 switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Official Title
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The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in Patients With Chronic Myeloid Leukemia in Chronic Phase: an Randomized Controlled Trial.

Conditions
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Chronic Myeloid Leukemia in Chronic Phase

Intervention / Treatment
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* Drug: Flumatinib
* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Diagnosis of CML-CP with Ph+; ECOG 0, 1, or 2; Patients with imatinib-related Low-grade Adverse Events for more than 12 months and AE lasting for at least 2 months, or relapsed at least 3 times in the past 12 months; Ability to provide written informed consent prior to any study related screening procedures being done Exclusion Criteria: Previously documented T315I mutation; Previous treatment with any other tyrosine kinase inhibitor except for imatinib; Prior accelerated phase or blast phase CML; Loss of CHR or cytogenetic response

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flumatinib<br>600mg QD orally form 1 to 12 months | Drug: Flumatinib<br>* Flumatinib 600mg QD orally form 1 to 12 months<br>|
| Placebo Comparator: Dasatinib<br>100mg QD orally form 1 to 12 months | Drug: Dasatinib<br>* Dasatinib 100mg QD orally form 1 to 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy. |  | 12 months | 
| Time to optimal imatinib-related adverse event improvement. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Myeloid Leukemia in Chronic Phase, Imatinib, Flumatinib, Dasatinib