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临床试验/NCT03715309
NCT03715309Unknown2 期

R2 in the Treatment of Follicular Lymphoma Grade 1-3A

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
115
试验地点
1
主要终点
CR

研究概览

简要总结

Lenalidomide Based Immunotherapy in the Treatment of FL

详细描述

Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular 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
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnose as de novo or relapse refractory FL grade 1-3A .
  • 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.

研究组 & 干预措施

Revlimd

Experimental

干预措施: Revlimid (Drug)

结局指标

主要结局

CR

时间窗: 12 weeks

Complete response rate

次要结局

  • PFS(1 year)
  • OS(1 year)
  • ORR(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhao Weili

Professor

Ruijin Hospital

研究点 (1)

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R2 in the Treatment of Follicular Lymphoma | 临床试验