TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients

A Randomized, Open-label, Multi-center Phase III Study Evaluating Efficacy and Safety of TGRX-678 Comparing to Investigator Selected Tyrosine Kinase Inhibitor (TKI) in CML-CP Patients Resistant From or Intolerant to at Least 3 TKI Treatments

A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs

This Phase III study is of randomized, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-CP patients. Patients need to have medical history of failing treatment(s) from at least 3 TKI drugs. Patients with or without T315I mutation is enrolled. Patients are randomized to either TGRX-678 treatment or TKI treatment at investigator's decision.

Inclusion Criteria:

• Willing to consent and to follow study procedures
• 18 years of age or above at time of screening; both sexes eligible
• Diagnosed with CML-CP and was intolerant to or failed from at least 3 TKI treatments
• ECOG score >= 2
• Adequate hematological indicators and have not used blood products or Colony-Stimulating Factor (CSF)
• Adequate kidney, liver and coagulation function
• Adequate QTc interval as confirmed by electrocardiogram (ECG) test
• Negative pregnancy result at screening for female patients of child-bearing potential
• Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)

Exclusion Criteria:

• Reception of TKI treatment or other anti-tumor treatments prior to first dose
• History or presence of extramedullary leukemia
• History of progression to CML-AP or BP
• Presence or having uncontrolled condition for cardiovascular diseases
• History of severe hemorrhagic disease
• Presence of malabsorption or other conditions that may affect drug absorption
• History of other primary malignancy within 5 years
• Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)
• In need for or having long-term immune suppressive treatment
• Reception of major surgery 28 days before first dose
• Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade >=1
• Presence of other conditions that the investigators or medical monitor deem unfit for the study