Actively Recruiting
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
Led by Shenzhen TargetRx Co., Ltd. · Updated on 2025-02-21
40
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
Sponsors
S
Shenzhen TargetRx Co., Ltd.
Lead Sponsor
P
Peking University People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide informed consent
- 18 years of age or older at screening; all genders eligible
- Relapsed or refractory after treatment with third-generation Tyrosine Kinase Inhibitors (TKIs)
- Patients without T315I mutation must have received first, second, and third generation TKIs
- Patients with T315I mutation must have been treated with Olverembatinib or Ponatinib
- Diagnosis of Accelerated Phase CML confirmed by bone marrow morphology, molecular biology, or cytogenetics
- ECOG performance status of 2 or less
- Life expectancy of at least 3 months
- Adequate blood cell counts
- Adequate kidney function
- Adequate liver function
- Adequate blood clotting function
- Adequate pancreatic function
- Normal QTc interval confirmed by ECG
- Negative pregnancy test at screening for females of child-bearing potential
- Willing to use contraception during the study (for males and females of child-bearing potential)
You will not qualify if you...
- Receiving TKI treatment or having unresolved TKI-related non-blood side effects within 7 days before first dose
- Receiving other anti-tumor treatments
- Needing immune suppressive treatment
- Using medications linked to Torsades de Pointes within 1 month before screening
- Having other medical conditions requiring treatments that may interact with the study drug
- History of hematopoietic stem cell transplant
- Active central nervous system conditions
- Already achieved major hematological response for CML-AP
- History of progression to Blast Phase
- Uncontrolled cardiovascular diseases
- History of heart or cardiovascular conditions (except controlled hypertension with blood pressure below 160/100 mmHg for at least 1 month before screening)
- Use of Traditional Chinese Medicine for anti-tumor purposes within 2 weeks before first dose
- Severe bleeding disorders unrelated to CML
- Severe cardiovascular issues during past TKI treatment
- History of pancreatic inflammation or alcohol abuse within 3 years before first dose
- Uncontrolled high triglyceride levels
- Malabsorption or conditions affecting drug absorption
- Diagnosis of other primary cancers within 5 years
- Major surgery within 14 days before first dose
- Active or continuous infections including HIV, hepatitis B, or hepatitis C
- Other conditions deemed unsuitable for the study by investigators or medical monitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yingkun Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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