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

Phase 4

• Conditions: Chronic Myeloid Leukemia in Chronic Phase
• Interventions: Drug: Dasatinib; Drug: Flumatinib

• Registration Number: NCT04933526
• Lead Sponsor: Shenzhen Second People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-21
• Study Start: 2021-07-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dasatinib	Dasatinib	100mg QD orally form 1 to 12 months
Flumatinib	Flumatinib	600mg QD orally form 1 to 12 months

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China