2024-510965-41-00招募中3 期
A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 54
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The primary objective of this study is to evaluate whether epcoritamab plus lenalidomide (E-Len) can improve outcomes as measured by progression-free survival (PFS) versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) in relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
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
- 否
入选标准
- •Subject must have histologically confirmed CD20+ DLBCL and documented in the most recent representative pathology report, inclusive of the following according to the 5th edition of the WHO (2022) Classification of Haematolymphoid Tumours: Lymphoid Neoplasms: • DLBCL, NOS including de novo or histologically transformed from an earlier diagnosis of FL or MZL • DLBCL/HGBCL with MYC and BCL2 rearrangements • Follicular large B-cell lymphoma (FLBL; previously FL Grade 3B) • T-cell/histiocyte-rich large B-cell lymphoma • Epstein Barr Virus-positive DLBCL
- •Subject must have R/R disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis. Note: Relapsed disease is defined as disease that has recurred ≥ 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
- •Subject must meet at least 1 of the following criteria: • Failed prior ASCT, defined as relapsed after ASCT or been refractory to ASCT • Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT • Be ineligible for or unable to receive CAR-T meeting at least 1 of the following criteria: • Unable to receive CAR-T therapy due to fitness and/or comorbidity • Lymphocyte apheresis failure • Unwilling to receive CAR-T therapy • Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints • Relapsed/progressed after having achieved at least a PR or CR while on prior CAR-T therapy
- •Subject must have measurable disease defined as: • ≥ 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT or MRI AND •F-FDG PET scan positive
- •Subject must have an Eastern Cooperative Oncology Group Performance status score of 0 to 2.
排除标准
- •Prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with R-GemOx or GemOx.
- •Lenalidomide exposure within 12 months prior to screening or history of documented refractoriness to lenalidomide with refractoriness defined as: • best response SD or PD, or • PD within 6 months of completion of the therapy
- •Best response to prior CAR-T therapy of SD or PD. Subject should not have received any treatment with CAR-T therapy within 90 days prior to randomization; any CAR-T related toxicity should have been resolved for at least 30 days.
- •Current evidence of primary CNS lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening
- •Current autoimmune disease requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent.
结局指标
主要结局
Progression-free survival (PFS)
Progression-free survival (PFS)
次要结局
- Percentage of Participants Who Achieve Complete response (CR)
- Overall Survival (OS)
- Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (54)
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