Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy proved CD20+ DLBCL;
- •relapse or refractory DLBCL#
- •previously received systemic chemotherapy with anthracycline#
- •not eligible for autologous hematopoietic stem cell transplantation#
- •at least one evaluable lesion#
- •ECOG PS 0-1;
- •18-75 years; without other malignancy;
- •proper functioning of the major organs.
排除标准
- •double-hit lymphoma;
- •previously received treatment of HDAC inhibitor;
- •plan to receive autologous stem cell transplantation;
- •involvement of central nervous system;
- •previously received gemcitabine within the past 6 months;
- •patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
研究组 & 干预措施
Chidamide combined with R-GemOx
Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy.
干预措施: Chidamide, Rituximab, Gemcitabine,Oxaliplatin (Drug)
结局指标
主要结局
ORR
时间窗: 4-years
the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
次要结局
- PFS(4-years)
- OS(4-years)
- DOR(4-years)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University