TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients (NCT07489755) | Clinical Trial Compass
Not Yet RecruitingPhase 3
TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients
180 participantsStarted 2026-04-01
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Event-free survival (EFS)
Timeframe: from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)