NCT04899414Unknown2 期
Study Evaluating the Safety and Efficacy of the Dexamethasone, Azacytidine, Pegaspargase, Tislelizumab With NK/T Cell Lymphoma
Peking University3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Overall response rate
研究概览
简要总结
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of Dexamethasone, azacytidine, Pegaspargase, Tislelizumab (DAPT) regimen for patients with newly diagnosed advanced stage ENKTL
, non-upper aerodigestive tract NK/T- cell lymphoma（NUAT- NKTCL）and relapsed refractory 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-70 years ,Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria
- •at least one measurable lesion
- •hemoglobin ≥90 g/l, absolute neutrophil count ≥ 1.5 × 10^9/L, platelets ≥ 75 ×10^9/L), ALT≤ 2 times upper limit of normal, serum creatinine ≤1.5 times upper limit of normal （If the above indicators are abnormal but are caused by the primary disease as assessed by the clinician, the treatment can be enrolled according to the clinical actual situation）
- •There was no other serious disease in conflict with this program
- •Adequate respiratory function
- •Adequate bone marrow function
- •Adequate renal and hepatic function
- •Not pregnant or nursing ,negative pregnancy test
- •No other active malignancy requiring therapy
- •No other serious or life-threatening condition deemed unacceptable by the principal investigator
- •Life expectancy ≥ 3 months
- •Able to understand and sign an informed consent form (ICF).
排除标准
- •NK/T cell lymphoma without confirmed pathological diagnosis;
- •Patients with early stage upper aerodigestive tract NK/T- cell lymphoma ;
- •Patients with drug allergies or metabolic disorders in the program;
- •Any uncontrolled medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction);
- •Severe infection (excluding the following: HBsAg or anti-HBc positive patients taking entecavir, tenofovir and other drugs;HCV RNA positive but taking direct anti-HCV drugs);
- •Invasion of primary or secondary central nervous system tumor invasion;
- •Contradictions to chemotherapy or radiotherapy;
- •Previously other malignancy requiring therapy;
- •Peripheral nervous system disorder or mental disorder;
- •Incapacity for legal conduct, medical or ethical reasons that affect the continuation of the research;
- •Other clinical investigators;
- •Combination of anti-tumor drugs outside the research program;
- •Participants evaluated inappropriate to participate in this study by principal investigator.
研究组 & 干预措施
Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma
Experimental
4-6 cycles of induction DAPT followed by Auto HSCT as consolidation for CR/PR fit patients ,then by PD-1 as maintenance treatment (up to 16 cycles) for received Auto-HSCT
干预措施: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab (Drug)
结局指标
主要结局
Overall response rate
时间窗: 1-year
To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma
次要结局
- Adverse events(1-year)
- Complete response rate(1-year)
- Progression-free survival(2-year)
- Overall survival(2-year)
研究者
Jun Zhu
Dr.
Peking University Cancer Hospital & Institute
研究点 (3)
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