JPRN-jRCT2080223801已完成1 期
A PHASE I STUDY OF RO7030816 IN PATIENTS WITH B-CELL NON-HODGKIN'S LYMPHOMA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
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
- •[Dose-escalation cohorts]
- •- Histologically documented CD20+ B-cell NHL.
- •- Patients with r/r B-cell NHL and no other standard therapy(standard chemotherapy, autologous hematopoietic stem cell transplantation, etc.) that should be prioritized.
- •- ECOG PS of 0 or 1.
- •- Life expectancy more than 12 weeks from the date of enrollment.
- •- Major organ function meets all criteria.
- •[Expansion cohort]
- •- Histologically documented CD20+ Grade 1-3a relapsed or refractory FL.
- •- Patient received at least two prior systemic lymphoma therapy includinganti-CD20 targeted therapies and alkylating agents.
- •- ECOG PS of 0 or 1.
- •- Life expectancy more than 12 weeks from the date of enrollment.
- •- Major organ function meets all criteria.
- •[2L+ FL SC cohort]
- •- Histologically documented CD20+ Grade 1-3a relapsed or refractory FL.
- •- Patient received at least one prior systemic lymphoma therapy.
- •- ECOG PS of 0 to 2.
- •- Life expectancy more than 12 weeks from the date of enrollment.
- •- Major organ function meets all criteria.
- •- Previously untreated patients with FL must require systemic therapy assessed by investigator based on Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
- •[3L+ FL SC cohort]
- •- Histologically documented CD20+ Grade 1-3a relapsed or refractory FL.
- •- Patient received at least two prior systemic lymphoma therapy includinganti-CD20 targeted therapies and alkylating agents.
- •- ECOG PS of 0 to 2.
- •- Life expectancy more than 12 weeks from the date of enrollment.
- •- Major organ function meets all criteria.
排除标准
- •[Dose-escalation cohorts, expansion cohort, 3L+ FL SC cohort]
- •- Pregnant or lactating woman.
- •- Current or previous autoimmune disease.
- •- Positive test result for human immunodeficiency virus antibody,hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody.
- •- Current or previous clinically significant liver disease.
- •- Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases.
- •- History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation.
- •- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.
- •[2L+ FL SC cohort]
- •- Pregnant or lactating woman.
- •- Current or previous autoimmune disease.
- •- Positive test result for human immunodeficiency virus antibody,hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody.
- •- Current or previous clinically significant liver disease.
- •- Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases.
- •- History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation.
- •- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.
- •- Patients at risk of hypersensitivity to lenalidomide and to excipients of lenalidomide
- •- Documented refractoriness to lenalidomide.
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