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

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Treatments: HH-GV-678

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.