Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure

Shenzhen University

Status and phase

Unknown

Phase 4

Conditions

Imatinib

Flumatinib

Chronic Myeloid Leukemia, Chronic Phase

Treatments

Drug: Flumatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04677439

Flumatinib20201216

Details and patient eligibility

About

The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

Full description

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years.
Diagnosis of CML-CP with Ph+.
ECOG performance of 0-2.
Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
Treatment failure after imatinib at 3 or 6 months with BCR-ABL >10%.
Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion criteria