CTIS2023-503206-37-00招募中1 期
A PHASE III, OPEN-LABEL, MULTICENTER RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATOR’S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA - GO43878
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 176
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Life expectancy >= 12 weeks, Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14), Relapsed or refractory disease, At least one (>= 1) line of prior systemic therapy that must include a BTK inhibitor, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2, Adequate hematologic function
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer, Leukemic, non-nodal MCL, Prior solid organ transplantation, prior allogeneic stem cell transplant, Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 and also treatment with chimeric antigen receptor T-cell (CAR-T) cell therapy, Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma, Known or suspected chronic active Epstein Barr viral infection, history of hemophagocytic lymphohistiocytosis (HLH) and progressive multifocal leukoencephalopathy (PML), Clinically significant history of cirrhotic liver disease
研究者
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