NCT02511340

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Flumatinib mesylate tablet 600 mg qd	Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2015-07-30
• Last updated: 2015-07-30

Locations

1 site across 1 country: China