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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Myeloid Leukemia, Chronic Phase; Flumatinib; Imatinib
• Intervention / Treatment: Drug: Flumatinib

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518035
      • Recruiting
      • The second people's Hospital of Shenzhen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flumatinib	Drug: Flumatinib; 600 mg of Flumatinib orally daily for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.	Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.	24 months

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital
• Collaborators: Hainan General Hospital; Sanya Central Hospital; First Affiliated Hospital of Shantou University Medical Collegeity; Peking University Shenzhen Hospital; Dongguan People's Hospital
• Investigators: Principal Investigator: Xin Du, Phd, Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Flumatinib, CML-CP with Ph+
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; HH-GV-678
• Other Study ID Numbers: Flumatinib20201216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No