招募中 NCT06717347

一項評估Zilovertamab Vedotin (MK-2140)與利妥昔單抗加環磷酰胺、阿黴素和強的鬆(R-CHP)組合與利妥昔單抗加環磷酰胺、阿黴素、長春新鹼和強的鬆(R-CHOP)組合在既往未治療的DLBCL參與者(MK-2140-010)中的研究

淋巴瘤肉瘤Phase IIII 期

本研究的目的是評估標準治療的zilovertamab vedotin是否可以幫助人們在沒有癌症生長或擴散的情況下,比單獨接受標準治療的人更長壽。

適應症:Diffuse Large B-Cell Lymphoma

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。