Chronic Myeloid LeukemiaPhase 2NCT06453902
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
A Phase 2 study testing TGRX-678 in people with Chronic Myeloid Leukemia and Accelerated Phase CML, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.
Trial summary
A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Accelerated Phase CML
- What is being tested?
- TGRX-678
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 30 Apr 2028
- Phase
- Phase 2
- 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
- 18 years of age or above at time of screening; both sexes eligible
- Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment
- For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
- For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment
- Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests
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- ECOG score </=2
- Minimum life expectancy of at least 3 months
- Adequate hematological indicators
- Adequate kidney function
- Adequate liver function
- Adequate coagulation function
- Adequate pancreatic 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)
Who cannot join
- Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose
- Reception of other anti-tumor treatments
- In need for immune suppressive treatment
- Usage of drugs associated with Torsades de Pointes within 1 months before screening
- Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug
- History of hemapoietic stem cell transplant
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- Presence of active central nervous system conditions
- CML-AP patients who already reached major hematological response
- CML-AP patients who used to progress to Blast Phase (BP)
- Presence or having uncontrolled condition for cardiovascular diseases
- History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160/100 mmHg for 1 months before screening)
- Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose
- Severe hemorrhagic disease unrelated to CML
- History of severe cardiovascular condition during past TKI treatment for CML
- History of pancreatic inflammation or alcohol abuse within 3 years before first dose
- Uncontrolled Hypertriglyceridemia
- Presence of malabsorption or other conditions that may affect drug absorption
- Diagnosis of other primary malignant tumor within 5 years
- Reception of major surgery 14 days before first dose
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Qian Jiang, MD, 010-88326666, Jiangqian@medmail.com
Qian Jiang, MD
About this study
Official title: A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment
A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment
Read the detailed description
This Phase II study is of single-arm, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-AP patients. Patients need to have medical history of failing treatment(s) from third-generation TKI drugs. Patients with or without T315I mutation is enrolled.
- Conditions
- Chronic Myeloid Leukemia, Accelerated Phase CML
- Being tested
- TGRX-678
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Accelerated Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGRX-678Drug
All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TGRX-678 | Experimental | All patients with CML-AP to be treated with TGRX-678. Patients with T315I mutation or without T315I mutation will be assigned into separate cohorts for evaluation Receives: Drug: TGRX-678 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Hematologic Response (MaHR)
Number of patients who reached, and rate of occurence of major hematologic response, including those who reached complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR and NEL are defined per China national treatment guideline for CML (ver. 2022). Indicators for hematologic responses will be obtained via peripheral blood tests.
Measured: At screening, on Day 1 of every treatment cycle (each cycle is 28 days) and at end of treatment; average of study duration is 3.5 years
Secondary outcomes (7)
Cytogenetic Response
Number of patients who reached, and rate of occurence of cytogenetic response, including those with major cytogenetic response (MCyR) or complete cytogenetic response (CCyR). Cytogenetic responses are defined per China national treatment guideline for CML (ver. 2022). Indicators for cytogenetic responses will be obtained via bone marrow biopsy.
Measured: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Major Molecular Response (MMR)
Number of patients who reached, and rate of occurence of MMR. Cytogenetic response is defined per China national treatment guideline for CML (ver. 2022). Indicators for molecular responses will be obtained via genetic testing on transcript levels of BCR-ABL gene.
Measured: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Time to Response (TTR)
TTR defined by the time from the start of treatment to the first efficacy response; TTR as evaluated by investigator
Measured: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Duration of Response (DOR)
DOR defined as the duration from first occurence of treatment response to progressive disease/relapse; DOR as evaluated by investigator
Measured: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Progression Free Survival (PFS)
PFS defined as the time from enrollment to progressive disease or death of any cause; PFS as evaluated by investigator.
Measured: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Overall Survival (OS)
OS defined as the time from enrollment to death of any cause; OS as evaluated by investigator
Measured: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Treatment Emergent Adverse Event (TEAE)
To record and analyse the occurence and frequency of adverse events during the study
Measured: Through completion of the study, an average of 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start15 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital, Henan Cancer Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Soochow University, Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University, Shenzhen Second People's Hospital, Ruijin Hospital, Shengjing Hospital, Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Qian Jiang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453902
- Sponsor's protocol ID
- TGRX-678-2001
- Status last verified
- Feb 2025
- First submitted
- 28 May 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment
- ClinicalTrials.gov ID
- NCT06453902
- Acronym / sponsor ID
- TGRX-678-2001
- Conditions
- Chronic Myeloid Leukemia, Accelerated Phase CML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital, Henan Cancer Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Soochow University, Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University, Shenzhen Second People's Hospital, Ruijin Hospital, Shengjing Hospital, Huazhong University of Science and Technology
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 12 Jun 2024 (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 II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment
Detailed description
This Phase II study is of single-arm, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-AP patients. Patients need to have medical history of failing treatment(s) from third-generation TKI drugs. Patients with or without T315I mutation is enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: TGRX-678 | Experimental | Drug: TGRX-678All patients with CML-AP to be treated with TGRX-678. Patients with T315I mutation or without T315I mutation will be assigned into separate cohorts for evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing to consent
- 18 years of age or above at time of screening; both sexes eligible
- Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment
- For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
- For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment
Key exclusion criteria (21 listed)
- Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose
- Reception of other anti-tumor treatments
- In need for immune suppressive treatment
- Usage of drugs associated with Torsades de Pointes within 1 months before screening
- Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug
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-678All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally | Drug | Experimental: TGRX-678 |
Primary outcome
Major Hematologic Response (MaHR)
Time frame: At screening, on Day 1 of every treatment cycle (each cycle is 28 days) and at end of treatment; average of study duration is 3.5 years
Number of patients who reached, and rate of occurence of major hematologic response, including those who reached complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR and NEL are defined per China national treatment guideline for CML (ver. 2022). Indicators for hematologic responses will be obtained via peripheral blood tests.
7 secondary outcomes
Cytogenetic Response
Time frame: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Major Molecular Response (MMR)
Time frame: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Time to Response (TTR)
Time frame: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Duration of Response (DOR)
Time frame: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Progression Free Survival (PFS)
Time frame: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Overall Survival (OS)
Time frame: At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years
Treatment Emergent Adverse Event (TEAE)
Time frame: Through completion of the study, an average of 3.5 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 21 Feb 2025.
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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.
Qian Jiang, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TGRX-678 in people with Chronic Myeloid Leukemia and Accelerated Phase CML, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.
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 16 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Yingkun Lu (18602219981, yingkun.lv@tjrbiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Hematologic Response (MaHR) (time frame: At screening, on Day 1 of every treatment cycle (each cycle is 28 days) and at end of treatment; average of study duration is 3.5 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 21 Feb 2025.