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

NCT ID: NCT04933526

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-06-30

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.

Conditions

Chronic Myeloid Leukemia in Chronic Phase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flumatinib

600mg QD orally form 1 to 12 months

Group Type: ACTIVE_COMPARATOR

Flumatinib

Intervention Type: DRUG

Flumatinib 600mg QD orally form 1 to 12 months

Dasatinib

100mg QD orally form 1 to 12 months

Group Type: PLACEBO_COMPARATOR

Dasatinib

Intervention Type: DRUG

Dasatinib 100mg QD orally form 1 to 12 months

Interventions

Flumatinib

Flumatinib 600mg QD orally form 1 to 12 months

Intervention Type: DRUG

Dasatinib

Dasatinib 100mg QD orally form 1 to 12 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Du

Role: CONTACT

duxingz@medmail.com.cn

075583366388

Facility Contacts

Xin Du, MD

Role: primary

duxingz@medmail.com.cn

075583366388 ext. 8196

Other Identifiers

20210609

Identifier Type: -

Identifier Source: org_study_id