CTIS2023-507236-20-00进行中（未招募）1 期
A Phase Ib/II, Open-Label, Multicenter Study with a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+LEN), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab+LEN in Patients with Follicular Lymphoma - CO41942
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 187
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
- •Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2, R/R FL after treatment with at least one prior systemic lymphoma therapy which includes prior immunotherapy or chemoimmunotherapy, Previously untreated patients with FL must require systemic therapy assessed by investigator based on GELF criteria, Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 as determined by the local laboratory, Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma), At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)
排除标准
- •Any history of Grade 3b FL, Any History of disease transformation and/or diffuse large B-cell lymphoma, Active or history of central nervous system lymphoma or leptomeningeal infiltration, Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy, Prior standard or investigational anti-cancer therapy as specified, Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1
研究者
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