Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Patients with newly diagnosed, pathologically confirmed NK/T-cell lymphoma of stage III-IV treated with XCOPL regimen. 3 weeks for a cycle, with a total of 6-8 cycles.
详细描述
Patients with newly diagnosed, pathologically confirmed NK/T-cell lymphoma of stage III-IV treated with XCOPL regimen. 3 weeks for a cycle, with a total of 6-8 cycles. Initial safety and PET-CT assessment were performed after 3 cycles of treatment (which could be delayed until 4 cycles of treatment in special cases). Patients who achieved partial remission or above will continue the original regimen, and patients who did not achieve partial remission or above will perform re-biopsy and be excluded from the group. Patients who remain partial remission by PET-CT evaluation after 6 cycles may switch to a second-line regimen (referring to NCCN guidelines, GDP regimen combined with selinexor is recommended). Chemotherapy will be performed for up to 8 cycles (followed by autologous or allogeneic hematopoietic stem cell transplantation), after which follow-up period was entered. It is recommended to perform ultrasound or CT evaluation, peripheral blood ctDNA and EBV copy number every three months during the first year of follow-up, and PET-CT evaluation every half a year.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥14 years, male or female;
- •Pathologically confirmed newly diagnosed NK/T cell lymphoma according to WHO classification criteria 2016;
- •At least one measurable lesion, defined as bidimensionally measurable, intranodal lesion > 1.5 cm in short axis and extranodal lesion > 1.0 cm in short axis;
- •ECOG score 0~2;
- •Clinical stage III~IV;
- •Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9/L, PLT ≥ 75 x 10 9/L, Hb ≥ 80 g/L; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg/dL; CCr ≥ 60 mL/min; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle
- •Expected survival > 6 months
- •Agree to use effective contraception;
- •Understand and voluntarily sign written informed consent
排除标准
- •Prior allogeneic HCT (allo-HCT)
- •Active autoimmune disease
- •Primary central nervous system lymphoma;
- •Patients with infection which requiring treatment. Could be re-enrollment after infection control;
- •Known history of human immunodeficiency virus (HIV) infection
- •Known hypersensitivity to the study drug or any of its excipients;
- •Presence of other active malignancy requiring treatment that could interfere with this study;
- •Patients with other conditions not suitable for enrollment as judged by the investigator.
研究组 & 干预措施
Treatment group
COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)
干预措施: XPO1 inhibitor (Drug)
结局指标
主要结局
response rate
时间窗: 1-year
complete remission + partial remission
Incidence of Treatment-Emergent Adverse Events
时间窗: 1-year
Incidence of Treatment-Emergent Adverse Events
次要结局
- the 1-year OS(1-year)
- the ctDNA and EBV copy number in peripheral blood(1-year)
- the 1-year PFS(1-year)
研究者
Yu Zhao
Chief physician
Chinese PLA General Hospital