jRCT2061240099招募中不适用
A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MSD K.K.
- 入组人数
- 72
- 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
- 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
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues.
- •Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
- •Has received no prior treatment for their DLBCL.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization.
- •Has an ejection fraction >=45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA).
- •Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
- •Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
排除标准
- •Has a history of transformation of indolent disease to DLBCL.
- •Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
- •Has Ann Arbor Stage I DLBCL.
- •Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >=II), or serious cardiac arrhythmia requiring medication.
- •Has clinically significant pericardial or pleural effusion.
- •Has ongoing Grade >1 peripheral neuropathy.
- •Has a demyelinating form of Charcot-Marie-Tooth disease.
- •HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- •Has ongoing corticosteroid therapy.
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- •Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- •Known active central nervous system (CNS) lymphoma.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years.
- •Has active infection requiring systemic therapy.
- •Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
- •Has history of allogeneic tissue/solid organ transplant.
结局指标
主要结局
-
progression-free survival
次要结局
未报告次要终点
研究者
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