JPRN-jRCT2021220043招募中3 期
[M20-621] Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Satomi Natsuko0 个研究点目标入组 900 人开始时间: 2023年2月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
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 < 80age old（—）
- 性别
- All
入选标准
- •Planned to receive treatment with 6 cycles of standard R-CHOP per investigator determination.
- •Must have newly diagnosed, 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:
- •DLBCL, Not Otherwise Specified (NOS).
- •High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
- •T-cell/histiocyte-rich large B-cell lymphoma.
- •Epstein Barr virus-positive DLBCL, NOS.
- •Follicular lymphoma Grade 3b.
- •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, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
- •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.
- •Must have an IPI score of 2-5. The number of participants with IPI 2 will be capped at 35% 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.
- •Has at least one target lesion defined as:
- •>= 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 MRI. AND
- •Positron emission tomography (PET)-positive on PET-CT scan.
- •Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
- •Laboratory values meeting the criteria laid out in the protocol.
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 vincristine 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.
研究者
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