CTIS2023-504994-19-00进行中（未招募）1 期
A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination with Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients with Untreated Diffuse Large B-Cell Lymphoma - GO43075
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Previously untreated patients with cluster of differential (CD20)-positive DLBCL, including diagnoses by the 2016 World Health Organization (WHO) classification of lymphoid neoplasms, International Prognostic Index (IPI): 1-5, Life expectancy of >=6 months, Adequate biomarker blood samples prior to initiation of R-CHOP on Day 1 of Cycle 1 and on Day 1 of Cycle 2 submitted for screening for determination of ctDNA status, At least one bi-dimensionally fluorodeoxyglucose (FDG)-avid measurable lymphoma lesion on positron emission tomography/computed tomography (PET/CT) scan, Left ventricular ejection fraction (LVEF) >=50%, as determined on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
排除标准
- •Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines, history of severe allergic or anaphylactic reactions to murine monoclonal antibodies, or known sensitivity or allergy to murine products, Prior treatment for indolent lymphoma, Prior solid organ or allogeneic stem cell transplant, Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable, Prior therapy for DLBCL and high-grade B-cell lymphoma (HGBCL) with the exception of palliative, short-term treatment with corticosteroids, Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the final dose of R-CHOP, 3 months after the final dose of tocilizumab (if applicable), or 2 months after the final dose of glofitamab
研究者
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