NCT03715296Unknown不适用
Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls)
- •Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL.
- •No history of stem cell transplantation.
- •Written informed consent.
排除标准
- •Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- •Clinically significant active infection.
- •Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- •Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- •Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- •Patients who are pregnant or breast-feeding.
- •HIV infection.
结局指标
主要结局
Complete response rate
时间窗: 12 weeks
次要结局
- Overall survival rate(1 year)
- Overall response rate(12 weeks)
- Progression free survival rate(1 year)
研究者
研究点 (1)
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