The Efficacy and Safety of Methotrexate, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (MEDA) With Autologous HSCT in the Treatment of Stage IV Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 7
- 主要终点
- Complete response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide, pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.
详细描述
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based chemotherapy improved overall response and prolonged the long-term survival for patients with stage IV. But the optimal treatment schedule has not been established. This study is designed with four cycles MEDA chemotherapy, followed by Auto-HSCT for stage IV patients with newly onset, relapsed or refractory diseases. The efficacy and safety of this protocol in the treatment of will be measured.
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
- •Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
- •Eastern Cooperative Oncology Group (ECOG ) performance status 0~
- •Stage IV disease with at least one measurable lesion.
- •Preserved organ functions for: Platelet>50×10*9/L, hemoglobin>80g/L, total bilirubin (TBIL)<3×ULN, alanine transaminase (ALT)<5×ULN, serum creatinine (Cr)<1.5×ULN, fibrinogen≥0.5g/L, LVEF≥50%.
- •Signed Informed consented.
排除标准
- •Relapsed or progressive disease to prior L-asparaginase-based chemotherapy.
- •Concurrent cancers need surgery or chemotherapy within 6 months.
- •History of chemotherapy or radiotherapy for other solid cancers within 3 years.
- •Recent history of radiotherapy of upper-aero-digestive tract within last 3 months.
- •Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, severe hemophagocytic lymphohistiocytosis.
- •Mental disorders.
- •Pregnant or lactation.
- •HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥10*5 copies/ml.
- •History of pancreatitis.
- •Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.
- •Enrolled in other trial treatment.
研究组 & 干预措施
MEDA/Auto-HSCT
Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT).
干预措施: MEDA (Drug)
MEDA/Auto-HSCT
Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT).
干预措施: Auto-HSCT (Procedure)
结局指标
主要结局
Complete response rate
时间窗: Day 28 of the 4th course of MEDA chemotherapy
The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
次要结局
- Overall survival(2-year)
- Progression free survival(2-year)
- Overall response rate(Day 28 of the 4th course of MEDA chemotherapy)
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Day 1 of each course of chemotherapy and then every 3 months for 2 years)
研究者
Rong Tao
Dr
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine