JPRN-jRCT2011220044招募中1 期
[M22-132] Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non- Hodgkin Lymphoma
Satomi Natsuko0 个研究点目标入组 132 人开始时间: 2023年3月14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
- 132
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
- •Diagnosis of diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
- •--DLBCL, not otherwise specified (NOS).
- •--High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 (double-hit or triple-hit) Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
- •--Follicular lymphoma Grade 3B.
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- •-Must have 1 or more measurable disease sites:
- •--A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
- •--At least 1 measurable nodal lesion (long axis >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.
排除标准
- •-Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
- •-Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia.
研究者
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