TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen TargetRx Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TGRX-678
DrugPatients will be given TGRX-678 for oral administration
TKI
DrugPatient will take TKI of investigator's choice for oral administration
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: TGRX-678Experimental treatment 1 intervention
Group B: TKIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
Hematologic Response
Rate of occurence of complete hematologic response (CHR).
Time frame
From randomization to end of study (estimated study duration: 5 years)2
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)3
Molecular Response
Rate of Occurence for Major Molecular Response (MMR)
Time frame
from randomization to end of study (estimated study duration: 5 years)4
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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