A Pilot Study of Anlotinib for the Evaluation of Safety and Efficacy in Patients With Stage IV Natural Killer/T-cell Lymphoma and Refractory to L-asparaginase Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of anlotinib 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 treatment for the patients with advanced disease and resistant to L-asparaginase based chemotherapy has not been established. The overall survival for these patients are very poor. This study is designed to evaluate the efficacy and safety of anlotinib in patients with stage IV ENKTCL and refractory to L-asparaginase based chemotherapy.
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.
- •stage IV disease and resistant to L-asparaginase-based combined chemotherapy.(Definition of L-asparaginase resistance: Progression during treatment or no response to treatment).
- •Eastern Cooperative Oncology Group (ECOG ) performance status 0~
- •Preserved organ functions for: absolute neutrophil counter (ANC)>1.0×109/L, Platelet>50×109/L, hemoglobin>80g/L, total bilirubin (TBIL)<2×ULN, alanine transaminase (ALT)<2×ULN, normal serum creatinine，fibrinogen≥1.0g/L, LVEF≥50%.
- •Signed Informed consented.
排除标准
- •patients with a disease resistant to L-asparaginase but may benefit from a radiotherapy.
- •HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.
- •Significant complications: autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis, disseminated intravascular coagulation, uncontrolled hypertension or diabetes, hemorrhagic or thrombotic events within 6 months.
- •Mental disorders.
- •Pregnant or lactation
- •Peptic ulcer
- •Enrolled in other trial treatment
研究组 & 干预措施
Anlotinib
patients will be given anlotinib 12 mg daily for continus 14 days every 21 days until disease progression.
干预措施: Anlotinib (Drug)
结局指标
主要结局
Overall response rate
时间窗: 12 weeks after the initiation of anlotinib treatment
The treatment response will be assessed every 12 weeks.
次要结局
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Day 1 of each course and then every 3 months for 2 years)
研究者
Rong Tao
Clinical Professor and Associate Director of Department of Hematology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine