CTIS2022-502113-28-00招募中1 期
A Phase 3, Open-Label, Randomized Study To Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Combined with Chemotherapy versus Rituxumab Combined with Chemotherapy in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-2) - R1979-ONC-2075
Regeneron Pharmaceuticals Inc.0 个研究点目标入组 717 人开始时间: 2023年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 717
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
- •Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV, Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, Adequate bone marrow and hepatic function, NOTE: Other protocol defined inclusion criteria apply
排除标准
- •Participants with central nervous system lymphoma or leptomeningeal lymphoma, Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma, Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, Recent major surgery and history or organ transplantation, A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol, NOTE: Other protocol defined exclusion criteria apply
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