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

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Second People's Hospital
• Collaborators: Dongguan People's Hospital; First Affiliated Hospital of Shantou University Medical Collegeity; Hainan General Hospital; Peking University Shenzhen Hospital; Sanya Central Hospital
• Treatments: HH-GV-678

Criteria

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:

• Previously documented T315I mutation.

• History of TKI treatments except of imatinib.

• History of undergone major surgery within 4 weeks.

• Patients unwilling or unable to comply with the protocol.

• Pregnant or breast-feeding patients.

• patients with other malignant tumor.