A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients

NCT ID: NCT02511340

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-12-31

Brief Summary

Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.

Detailed Description

Multi-center, single-arm, open-label,phase II study to investigate efficacy and safety of Flumatinib in Chinese patients with accelerated or blastic Phase chronic myelogenous leukemia. The starting daily oral dose of Flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. The longest treatment time is 12 cycles.

Conditions

Chronic Myelogenous Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flumatinib mesylate tablet 600 mg qd

Flumatinib, 600mg, qd

Group Type: EXPERIMENTAL

Flumatinib mesylate tablet 600 mg qd

Intervention Type: DRUG

Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Interventions

Flumatinib mesylate tablet 600 mg qd

Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients age 18-75 year-old;
• ECOG 0 - 2;
• Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase;
• Adequate organ function;
• Written informed consent prior to any study procedures being performed.

Exclusion Criteria

• Patients in Chronic and Blastic Phases;
• Previously treated with Flumatinib;
• Previously documented T315I mutations;
• Previous therapy within protocol defined timeframe, including:

• hydroxyurea within 24 hr,
• Imatinib or Nilotinib or Dasatinib within 28 days)
• Cardiac dysfunction ;
• History of congenital or acquired bleeding disorders unrelated to CML;
• Central nervous system leukemia;
• Previous malignancy except CML;
• Acute or chronic liver or severe kidney disease unrelated to CML;
• Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaiyan Liu

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

Union Hospital Tongji Medical College Huazhong University of Science and technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

HHGV678-204

Identifier Type: -

Identifier Source: org_study_id