The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Flumatinib 600mg QD orally form 1 to 12 months |
Drug: Flumatinib
Flumatinib 600mg QD orally form 1 to 12 months
|
Placebo Comparator: Dasatinib 100mg QD orally form 1 to 12 months |
Drug: Dasatinib
Dasatinib 100mg QD orally form 1 to 12 months
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years;
-
Diagnosis of CML-CP with Ph+;
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ECOG 0, 1, or 2;
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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;
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Ability to provide written informed consent prior to any study related screening procedures being done
Exclusion Criteria:
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Previously documented T315I mutation;
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Previous treatment with any other tyrosine kinase inhibitor except for imatinib;
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Prior accelerated phase or blast phase CML;
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Loss of CHR or cytogenetic response
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Shenzhen Second People's Hospital | Shenzhen | Guangdong | China | 518035 |
Sponsors and Collaborators
- Shenzhen Second People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20210609