The Efficacy and Safety of Anti-PD-1 Antibody in Combination With Pegaspargase in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
试验速览
- 阶段
- 2 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This open-label, single arm study will evaluate the efficacy and safety of anti-PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.
详细描述
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. L-asparaginase-based chemotherapy has improved the survival for these patients with advanced stage. However, there is no standard of care for those patients with advanced stage. Anti-PD-1 antibody has been proven its efficacy in relapsed or refractory NK/T cell lymphoma. This open-label, single arm study will evaluate the efficacy and safety of PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed NK/T cell lymphoma based on 2016 WHO classification
- •Treatment naive
- •Age > 18 years
- •Advanced stage
- •Must has measurable lesion in CT or PET-CT prior to treatment
- •ECOG 0,1,2
- •Informed consented
排除标准
- •Aggressive NK/T-cell leukemia
- •Has accepted PD-1,PD-L1 or PD-L2 antibody before
- •Has accepted autologous Stem cell transplantation before
- •History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Primary CNS lymphoma
- •Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<50*10^9/L; ALT or AST >3*ULN; Creatinine>2*ULN
- •Other uncontrollable medical condition that may that may interfere the participation of the study
- •Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
- •HIV infection
- •HBV-DNA or HCV-RNA positive
- •Diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose.
- •Received attenuated live vaccine 4 weeks prior to first dose.
研究组 & 干预措施
Anti-PD-1 antibody plus pegaspargase
Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)
干预措施: Pegaspargase (Drug)
Anti-PD-1 antibody plus pegaspargase
Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)
干预措施: Anti-PD-1 monoclonal antibody (Drug)
结局指标
主要结局
Complete response rate
时间窗: At the end of Cycle 6 (each cycle is 21 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.
次要结局
- EBV-DNA load change(End of induction treatment (approximately 1 year))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Baseline up to data cut-off (up to approximately 4 years))
- Overall response rate(At the end of Cycle 6 (each cycle is 21 days))
- Overall survival(Baseline up to data cut-off (up to approximately 4 years))
- Duration of response(Baseline up to data cut-off (up to approximately 4 years))
- Progression free survival(Baseline up to data cut-off (up to approximately 4 years))
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores(Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days))
- Treatment related mortality(Baseline up to data cut-off (up to approximately 4 years))
研究者
Zhao Weili
First Deputy Director，Hematology Department
Ruijin Hospital