jRCT2021230015招募中不适用
Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial (EPCORE TM DLBCL-3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Genmab
- 入组人数
- 12
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 75age old over 至 No limit（—）
- 性别
- All
入选标准
- •Must have newly diagnosed CD20+ large cell lymphoma.
- •Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:
- •Being age >= 80 years; AND/OR
- •Being age >= 75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy.
- •Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of
- •Have Ann Arbor Stage II-IV disease.
- •Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to <= 2 prior to enrollment).
- •Have measurable disease as per Lugano criteria.
- •Have acceptable organ function based on baseline bloodwork.
- •Must have fresh (preferred) or archival biopsy material at screening.
排除标准
- •Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection.
- •Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy),
- •Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes:
- •Major surgery within 4 weeks prior to the first dose of epcoritamab;
- •Non-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab;
- •Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation;
- •Live, attenuated vaccines within 30 days prior to initiation of epcoritamab;
- •Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed);
- •Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab.
- •Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture.
- •Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.
- •Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol.
- •Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS).
- •Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]- positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis.
- •Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.
- •Has suspected active or inadequately treated latent tuberculosis.
- •Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
结局指标
主要结局
-
Complete response (CR) rate determined by Lugano criteria
次要结局
未报告次要终点
研究者
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