NCT04306887Unknown2 期
A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 in Subjects With Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with relapsed/refractory anaplastic large cell lymphoma (ALCL) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Female or male, 10 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •3.Histologically or cytologically confirmed ALK positive relapsed or refractory Anaplastic Large Cell Lymphoma.
- •4.At least one measurable lesion. 5.Life expectancy ≥ 3 months. 6.Adequate organ system function. 7.Understood and signed an informed consent form.
排除标准
- •1.Primary cutaneous anaplastic large cell lymphoma. 2.Other malignancies occurred within 5 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors.
- •3.Has received ALK inhibitor. 4.Has received an allogeneic stem cell transplant. 5.Has received autologous stem cell transplant within 12 weeks before the first administration.
- •6.Has received other anti-tumor medications within 4 weeks of the first administration.
- •7.Has received major surgery within 4 weeks before the first administration. 8.Has received any curative radiotherapy or minor surgery within 2 weeks before the first administration.
- •9.Has received palliative radiation therapy within 2 days before the first administration.
- •10.Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade
- •11.Has uncontrollable congestive heart failure. 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQ-B3101
Experimental
TQ-B3101 capsule administered orally.
干预措施: TQ-B3101 capsule (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Baseline up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR) according to Lugano response criteria.
次要结局
- Progression free survival (PFS) within 2-year(Baseline up to 24 months)
- Overall survival (OS) within 2-year(Baseline up to 24 months)
研究者
研究点 (1)
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