Maintenance Treatment of Chidamide in Chemotherapy-responded Stage IV or Relapsed/Refractory Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Extranodal natural killer/T-cell lymphoma, nasal type (NKTCL) is a highly aggressive peripheral T-cell lymphoma (PTCL). Patients with newly diagnosed stage IV and relapsed/refractory have poor prognosis. 5-year progression-free survival was reported only 55%. Chidamide is a selective histone deacetylase inhibitor which was approved by FDA in treating relapsed or refractory PTCL. In phase I and II studies of chidamide, patients with relapsed or refractory NKTCL achieved a higher overall remission. Patients who obtained complete or partial remission had much favourable duration of remission. Thus, the invesgator design this study to evaluate the role of maintenance treatment of chidamide for induction chemotherapy-responded newly-diagnosed advanced and relapsed/refractory NKTCL patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
- •newly-diagnosed stage IV disease or relapsed or refractory disease；
- •age ≥ 18 years;
- •ECOG performance status 0-2;
- •at least one measurable lesion;
- •adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
- •life expectancy of more than 3 months.
排除标准
- •Patients with newly-diagnosed stage I-II disease;
- •pregnancy or lactation;
- •any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
结局指标
主要结局
PFS
时间窗: 1 year
PFS was defined as the period from the date of treatment till the date of disease progression, relapse, or death from any cause.
次要结局
未报告次要终点
研究者
Mei Dong
Medical doctor
Chinese Academy of Medical Sciences