A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, 环磷酰胺, 盐酸阿霉素, 长春新碱, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell 淋巴瘤 (DLBCL)
关于
B-cell 淋巴瘤 is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, 环磷酰胺, 盐酸阿霉素, 长春新碱, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). 将评估疾病活动的变化.
Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. 受试者将接受epcoritamab联合R-CHOP治疗, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.
抱在怀里1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. 抱在怀里2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, 血液测试, 问卷调查和副作用.
资格
入选标准:
- Planned to receive treatment with 6 cycles of standard rituximab, 环磷酰胺, 盐酸阿霉素, 长春新碱, 和泼尼松(R-CHOP).
- 必须是新诊断的, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
- 未指定的DLBCL (NOS).
- High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
- t细胞/组织细胞丰富的大b细胞淋巴瘤.
- eb病毒阳性DLBCL, NOS.
- 滤泡性淋巴瘤3b级. Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology. Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, 人疱疹病毒8型阳性DLBCL, 或原发性积液性淋巴瘤.
- Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
- 必须有IPI得分2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
- 至少有一个目标病灶定义为:
- >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). 和
- Positron emission tomography (PET)-positive on PET-CT scan.
- Laboratory values meeting the criteria laid out in the protocol.
- Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
排除标准:
- History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without 长春新碱 during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
- Clinically significant cardiovascular disease as per the protocol.
加入这个试验
- 皇冠hga025大学圣莫尼卡分校
- 皇冠hga025大学洛杉矶分校韦斯特伍德