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

Chronic Myeloid Leukemia in Chronic Phase Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933526
• Other study ID #: 20210609
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: Shenzhen Second People's Hospital
• Contact: Xin Du
• Phone: 075583366388
• Email: duxingz[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia in Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Flumatinib
Flumatinib 600mg QD orally form 1 to 12 months
• Dasatinib
Dasatinib 100mg QD orally form 1 to 12 months

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.		12 months
Secondary	Time to optimal imatinib-related adverse event improvement.		12 months