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

Shenzhen University

Status and phase: Enrolling; Phase 4

Conditions: Chronic Myeloid Leukemia in Chronic Phase

Treatments: Drug: Flumatinib; Drug: Dasatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04933526

20210609

Details and patient eligibility

About

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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups, including a placebo group

Flumatinib

Active Comparator group

Description:

600mg QD orally form 1 to 12 months

Treatment:

Drug: Flumatinib

Dasatinib

Placebo Comparator group

Description:

100mg QD orally form 1 to 12 months

Treatment:

Drug: Dasatinib