NCT02929615Unknown4 期
Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors
Peking University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapse and refractory lymphoma and multiple myeloma.
- •At least 1 measurable lesions and its size≥15mm.
- •Patients ≤65 years，no limitations for both gender.
- •ECOG score is 0-
- •Life expectancy≥3 months.
- •LVEF≥ 55%; Peripheral blood: WBC ≥ 3.5×10(9)/L,neutrophil ≥1.5×10(9)/L, PLT≥75×109/L，Hb≥90g/L; Renal function: Cr≤2.0×UNL; Liver function: BIL≤2.0×UNL，ALT/AST≤2.5×UNL;
- •Written informed consent are acquired.
排除标准
- •Previously received stem cell transplantation.
- •Women with pregnant, lactating or not to take contraceptive measures.
- •Severe acute infection or suppurative and chronic infection that wound not healing.
- •Severe heart failure.
- •Suffering from mental disorders and poor compliance.
- •Other situations that investigators consider as contra-indication for this study.
研究组 & 干预措施
Treatment group
Experimental
干预措施: Hematopoietic stem cell transplantation (Other)
结局指标
主要结局
overall response rate
时间窗: 2 years after treatment
overall survival
时间窗: 2 years after treatment
complete response
时间窗: 2 years after treatment
progression-free survival
时间窗: 2 years after treatment
次要结局
未报告次要终点
研究者
Jun Zhu
Director
Peking University
研究点 (1)
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