NCT07489755尚未招募3 期
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
Shenzhen TargetRx Co., Ltd.0 个研究点目标入组 180 人开始时间: 2026年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Event-free survival (EFS)
时间窗: 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
次要结局
- Hematologic Response(From randomization to end of study (estimated study duration: 5 years))
- Cytogenetic Response(from randomization to end of study (estimated study duration: 5 years))
- Molecular Response(from randomization to end of study (estimated study duration: 5 years))
- Progression Free Survival (PFS)(from randomization to end of study (estimated study duration: 5 years))
- Overall Survival (OS)(from randomization to end of study (estimated study duration: 5 years))
- Treatment Emergent Adverse Event (TEAE)(from randomization to end of study (estimated study duration: 5 years))
研究者
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