NCT06173999招募中1 期
A Phase Ib/II, Open-label, Multi-center Study of SHR2554 With CHOP/CHOEP in Treatment-naïve Patients With Peripheral T-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety endpoints: incidence and severity of adverse events (AEs)
研究概览
简要总结
The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18-70 years (inclusive);
- •Histologically confirmed peripheral T-cell lymphoma;
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
- •Life expectancy ≥ 12 weeks;
- •Have measurable lesions ;
- •The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.
排除标准
- •Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
- •Known active HBV or HCV infection;
- •History of clinically significant cardiovascular disease;
- •History of other malignancies within 5 years;
- •Pregnant or lactating women;
- •Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination.
研究组 & 干预措施
Treatment group B
Experimental
干预措施: SHR2554/CHOEP (Drug)
Treatment group A
Experimental
干预措施: SHR2554/CHOP (Drug)
结局指标
主要结局
Safety endpoints: incidence and severity of adverse events (AEs)
时间窗: through study completion, an average of about 6 months
Ib phase
Overall response rate (ORR)
时间窗: 90 days since the date of first dose
II phase
次要结局
- Incidence and severity of adverse events (AEs)(through study completion, an average of about 6 months)
- Plasma concentration(Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle))
- Progression Free Survival (PFS)(through study completion, an average of about 6 months)
- Overall Survival (OS)(2 years since the date of first dose)
- Duration of response (DOR)(through study completion, an average of about 6 months)
研究者
研究点 (1)
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