NCT07489755Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 May 2030
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT07489755
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 180
- From 1 Apr 2026 to the primary completion date, 1 May 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Reception of TKI treatment or other anti-tumor treatments prior to first dose
- Reception of major surgery 28 days before first dose
- Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade \>=1
Other illness
- 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)
- Presence of other conditions that the investigators or medical monitor deem unfit for the study
Other
- History or presence of extramedullary leukemia
- In need for or having long-term immune suppressive treatment
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.