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

Phase 4

• Conditions: Flumatinib; Chronic Myeloid Leukemia, Chronic Phase; Imatinib
• Interventions: Drug: Flumatinib

• Registration Number: NCT04677439
• Lead Sponsor: Shenzhen Second People's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-21
• Study Start: 2021-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16
• Primary Completion: 2023-05-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flumatinib	Flumatinib	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.	12 months	Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.	3, 6, 9, 12 months.	Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Proportion of patients with MMR at 3, 6, 9 months.	3, 6, 9 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.	24 months	Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.	3, 6, 9, 12 months.	Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.

Trial Locations

Locations (1)

The Second People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China