A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Complete 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 pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria
- •age 14-80 years
- •no prior chemotherapy or radiotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •at least one measurable lesion
- •adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10^9/L, platelets ≥ 100 ×10^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal)
- •expected survival of more than three months
排除标准
- •invasion of lymphoma to central nervous system
- •pre-existing coagulation disorder
- •other concomitant neoplasms
- •severe infection
- •positive HIV antibody
- •HBV DNA titer higher than 10^4 copies /ml in HBsAg-positive patients post antiviral therapy
- •pregnant or lactating women
- •women of childbearing age unwilling to take contraceptive measures during the study period
研究组 & 干预措施
Stage I/II nasal ENKTL
2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation
干预措施: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone (Drug)
Stage III/IV or primary extra-nasal ENKTL
6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation
干预措施: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone (Drug)
结局指标
主要结局
Complete response rate
时间窗: 1 year
次要结局
- Overall response rate(1 year)
- Progression-free survival(3-year)
- Overall survival(3-year)
- Adverse events(1-year)
研究者
Jun Zhu
Dr.
Peking University Cancer Hospital & Institute