JPRN-jRCT2021210065进行中（未招募）3 期
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma - InMIND
Eiji Ueda0 个研究点目标入组 618 人开始时间: 2022年1月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 618
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
- •- Willingness to avoid pregnancy or fathering children
- •- In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
- •- Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
- •- Documented relapsed, refractory, or PD after treatment with systemic therapy
- •- ECOG performance status of 0 to 2
排除标准
- •- Women who are pregnant or breastfeeding.
- •- Any histology other than FL and MZL or clinical evidence of transformed lymphoma
- •- Prior non-hematologic malignancy
- •- Congestive heart failure
- •- HCV positivity, chronic HBV infection or history of HIV infection
- •- Active systemic infection
- •- CNS lymphoma involvement
- •- Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
- •- Prior use of lenalidomide in combination with rituximab
研究者
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