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

Chronic Myeloid Leukemia, Chronic Phase Clinical Trial

Official title:

Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677439
• Other study ID #: Flumatinib20201216
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2022
• Source: Shenzhen Second People's Hospital
• Contact: Xin Du, Phd
• 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 flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: May 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 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.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia, Chronic Phase
• Flumatinib
• Imatinib
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Flumatinib
600 mg of Flumatinib orally daily for 24 months

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital	Dongguan People's Hospital, First Affiliated Hospital of Shantou University Medical Collegeity, Hainan General Hospital, Peking University Shenzhen Hospital, Sanya Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.	Major molecular response (MMR) is defined as BCR-ABL1 = 0.1 percent.	12 months
Secondary	Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.	Molecular response (MR) 4.0 is defined as BCR-ABL transcripts = 0.01 percent.	3, 6, 9, 12 months.
Secondary	Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.	Molecular response (MR) 4.5 is defined as BCR-ABL transcripts = 0.0032 percent.	3, 6, 9, 12 months.
Secondary	Proportion of patients with MMR at 3, 6, 9 months.		3, 6, 9 months
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.	Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.	24 months