Clinical trial · Interventional
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
NCT07489755CI-TRIAL-00106373not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myelogenous Leukemia - Chronic Phase | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TGRX-678 | Drug | — | UNRESOLVED |
| TKI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TGRX-678
- description
- Patients randomly assigned to this arm will take TGRX-678 as treatment for CML
- interventionNames
- Drug: TGRX-678
- type
- ACTIVE_COMPARATOR
- label
- TKI
- description
- Patients randomly assigned to this arm will take TKI of investigator's choice as treatment for CML
- interventionNames
- Drug: TKI
Primary outcomes (1)
- measure
- Event-free survival (EFS)
- timeFrame
- from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.