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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Event-free survival (EFS)
EFS measures time duration between randomization to disease progression, treatment failure, loss of efficacy, development of new mutation, or death, whichever occurs first
Time frame: from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)
Hematologic Response
Rate of occurence of complete hematologic response (CHR).
Time frame: From randomization to end of study (estimated study duration: 5 years)
Cytogenetic Response
Rate of occurence of Major Cytogenetic Response (MCyR) and Complete Cytogenetic Response (CCyR).
Time frame: from randomization to end of study (estimated study duration: 5 years)
Molecular Response
Rate of Occurence for Major Molecular Response (MMR)
Time frame: from randomization to end of study (estimated study duration: 5 years)
Progression Free Survival (PFS)
Duration between enrollment to progressive disease or death of any cause
Time frame: from randomization to end of study (estimated study duration: 5 years)
Overall Survival (OS)
Duration between enrollment to death of any cause
Time frame: from randomization to end of study (estimated study duration: 5 years)
Treatment Emergent Adverse Event (TEAE)
To record and analyse the occurence and frequency of adverse events during the study
Time frame: from randomization to end of study (estimated study duration: 5 years)
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