NCT04021992Unknown2 期
GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single Arm, Phase II Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年7月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 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 GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy proved CD20+ DLBCL;
- •previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
- •at least one evaluable lesion；
- •ECOG PS 0-1;
- •18-65 years;
- •proper functioning of the major organs.
排除标准
- •involvement of central nervous system;
- •with other malignancy;
- •patients receiving or received drug of other clinical trial within 30 days；
- •previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)；
- •patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
- •grade 2 or more peripheral neuropathy.
研究组 & 干预措施
GVD with or without R
Experimental
Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.
干预措施: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab (Drug)
结局指标
主要结局
ORR
时间窗: 4-years
次要结局
- PFS(4-years)
- EFS(4-years)
- success rates in autologous stem cell mobilization(4-years)
- OS(4-years)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University
研究点 (1)
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