2023-504994-19-00招募中2 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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- 1. EOT CR rate, as determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma
研究概览
简要总结
To evaluate the efficacy of glofitamab in combination with R-CHOP in circulating-tumor DNA (ctDNA) high-risk patients with previously untreated DLBCL based on end of treatment (EOT) complete response (CR) rate as determined by the investigator according to 2014 Lugano Response Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Phase Ii Study Evaluating Safety And Efficacy Of Glofitamab In Patients With Large B-cell Lymphoma
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
1. EOT CR rate, as determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma
1. EOT CR rate, as determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma
次要结局
- 1. ORR at the EOT, as determined by the investigator according to the 2014 Lugano Response Criteria
- 2. PFS, as determined by the investigator according to the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first
- 3. OS
- 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
- 5. Tolerability, as assessed by dose modifications, dose intensity, and study treatment discontinuation because of adverse events
- 6. Serum concentrations of glofitamab at specified timepoints
- 7. Serum trough concentrations of glofitamab at specified timepoints
- 8. Maximum concentration (Cmax) of glofitamab at specified timepoints
- 9. Area under the concentration–time curve (AUC) of glofitamab at specified timepoints
- 10. Relationship between ADA status and efficacy, safety, or PK endpoints
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (10)
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