BridgeMD
New treatment option for Chronic Myeloid Leukemia
Official title TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
ClinicalTrials.gov ID: NCT06453902
What this study is testing
What is TGRX-678?
TGRX-678 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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)
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.