NCT03595657已完成2 期
A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 17
- 主要终点
- Objective Response Rate (ORR) Assessed by IRRC
研究概览
简要总结
This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)
详细描述
Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death. The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have a histologically confirmed NKTL at study site.
- •Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
- •Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
- •Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
- •Subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
排除标准
- •Invasive natural killer leukemia.
- •Concomitant with hemophagocytic syndrome.
- •Primary site in central nervous system (CNS) or CNS involvement.
- •Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS
- •Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS
- •Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS
- •Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS
- •Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
- •Subjects with active hepatitis B or C infection.
- •Subjects with active tuberculosis infection.
- •Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody.
- •Female subjects who are pregnant or breast-feeding.
- •For more information regarding trial participation, please contact at cstonera@cstonepharma.com
结局指标
主要结局
Objective Response Rate (ORR) Assessed by IRRC
时间窗: From enrollment to end of follow-up, a median of 29 months
ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
次要结局
- Time to Response (TTR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
- Complete Response Rate (CRR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
- Duration of Response (DoR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
- Objective Response Rate (ORR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
- Partial Response Rate (PRR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
- Partial Response Rate (PRR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
- Complete Response Rate (CRR) by Investigators(From enrollment to end of follow-up, a median of 29 months)
- Time to Response (TTR) Assessed by Investigators(From enrollment to end of follow-up, a median of 29 months)
- Duration of Response (DoR) Assessed by IRRC(From enrollment to end of follow-up, a median of 29 months)
- Number of Participants With Adverse Events(From enrollment to end of follow-up, a median of 29 months)
研究者
研究点 (17)
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