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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04933526

Enrollment

118

Registered

2021-06-21

Start date

2021-07-01

Completion date

2023-06-30

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia in Chronic Phase

Keywords

Chronic Myeloid Leukemia in Chronic Phase, Imatinib, Flumatinib, Dasatinib

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.

Interventions

DRUGFlumatinib

Flumatinib 600mg QD orally form 1 to 12 months

DRUGDasatinib

Dasatinib 100mg QD orally form 1 to 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Contacts

Primary ContactXin Du

duxingz@medmail.com.cn075583366388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026