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

Phase 2

• Conditions: Chronic Myelogenous Leukemia
• Interventions: Drug: Flumatinib mesylate tablet 600 mg qd

• Registration Number: NCT02511340
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-26
• Study First Submitted QC: 2015-07-29
• Last Update Submitted: 2015-07-29
• Study First Posted: 2015-07-30
• Last Update Posted: 2015-07-30
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flumatinib mesylate tablet 600 mg qd	Flumatinib mesylate tablet 600 mg qd	Flumatinib, 600mg, qd

Primary Outcome Measures

Name	Time	Method
Confirmed overall hematologic response（OHR）at 6 months	6 months

Trial Locations

Locations (1)

Union Hospital Tongji Medical College Huazhong University of Science and technology; 🇨🇳 Wuhan, Hubei, China