Chronic Myelogenous LeukemiaPhase 3NCT07489755
TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients
A Phase 3 study testing TGRX-678 and TKI in people with Chronic Myelogenous Leukemia and Chronic Myelogenous Leukemia - Chronic Phase, run by Shenzhen TargetRx Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia - Chronic Phase
- What is being tested?
- TGRX-678 and TKI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 May 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
About this study
Official title: 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
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
Read the detailed description
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.
- Being tested
- TGRX-678, TKI
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGRX-678Drug
Patients will be given TGRX-678 for oral administration
TKIDrug
Patient will take TKI of investigator's choice for oral administration
| Study group | Role | What they receive |
|---|---|---|
| TGRX-678 | Experimental | Patients randomly assigned to this arm will take TGRX-678 as treatment for CML Receives: Drug: TGRX-678 |
| TKI | Active comparator | Patients randomly assigned to this arm will take TKI of investigator's choice as treatment for CML Receives: Drug: TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)
Secondary outcomes (6)
Hematologic Response
Rate of occurence of complete hematologic response (CHR).
Measured: 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).
Measured: from randomization to end of study (estimated study duration: 5 years)
Molecular Response
Rate of Occurence for Major Molecular Response (MMR)
Measured: 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
Measured: from randomization to end of study (estimated study duration: 5 years)
Overall Survival (OS)
Duration between enrollment to death of any cause
Measured: 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
Measured: from randomization to end of study (estimated study duration: 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489755
- Sponsor's protocol ID
- TGRX-678-3001
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07489755
- Acronym / sponsor ID
- TGRX-678-3001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TGRX-678 | Experimental | Drug: TGRX-678Patients randomly assigned to this arm will take TGRX-678 as treatment for CML |
| TKI | Active comparator | Drug: TKIPatients randomly assigned to this arm will take TKI of investigator's choice as treatment for CML |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGRX-678Patients will be given TGRX-678 for oral administration | Drug | TGRX-678 |
| TKIPatient will take TKI of investigator's choice for oral administration | Drug | TKI |
Primary outcome
Event-free survival (EFS)
Time frame: from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)
EFS measures time duration between randomization to disease progression, treatment failure, loss of efficacy, development of new mutation, or death, whichever occurs first
6 secondary outcomes
Hematologic Response
Time frame: From randomization to end of study (estimated study duration: 5 years)
Cytogenetic Response
Time frame: from randomization to end of study (estimated study duration: 5 years)
Molecular Response
Time frame: from randomization to end of study (estimated study duration: 5 years)
Progression Free Survival (PFS)
Time frame: from randomization to end of study (estimated study duration: 5 years)
Overall Survival (OS)
Time frame: from randomization to end of study (estimated study duration: 5 years)
Treatment Emergent Adverse Event (TEAE)
Time frame: from randomization to end of study (estimated study duration: 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TGRX-678 and TKI in people with Chronic Myelogenous Leukemia and Chronic Myelogenous Leukemia - Chronic Phase, run by Shenzhen TargetRx Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.