Multi-center, Single Stage Phase II Study to Evaluate the Efficacy and Safety of Flumatinib in Accelerated or Blastic Phase Chronic Myelogenous Leukemia Patients

Jiangsu Hansoh Pharmaceutical Co., Ltd.1 site in 1 country167 target enrollmentJanuary 2013

ConditionsChronic Myelogenous Leukemia

InterventionsFlumatinib mesylate tablet 600 mg qd

DrugsFlumatinib mesylate tablet 600 mg qd

Overview

Phase: Phase 2
Intervention: Flumatinib mesylate tablet 600 mg qd
Conditions: Chronic Myelogenous Leukemia
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Enrollment: 167
Locations: 1
Primary Endpoint: Confirmed overall hematologic response（OHR）at 6 months
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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.