招募中 NCT06717347

一项评估Zilovertamab Vedotin (MK-2140)与利妥昔单抗加环磷酰胺、阿霉素和强的松(R-CHP)组合与利妥昔单抗加环磷酰胺、阿霉素、长春新碱和强的松(R-CHOP)组合在既往未治疗的DLBCL参与者(MK-2140-010)中的研究

淋巴瘤肉瘤Phase IIII 期

本研究的目的是评估标准治疗的zilovertamab vedotin是否可以帮助人们在没有癌症生长或扩散的情况下,比单独接受标准治疗的人更长寿。

适应症:Diffuse Large B-Cell Lymphoma

入组条件

纳入标准

  • Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing 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

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。