A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

A vizsgálat adatai

Ki végzi

Merck Sharp & Dohme LLC

Azonosító

NCT06890884EU 2024-515526-89-00

A regiszteradat frissítve

2026. november 3.

Eredeti leírás

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.A teljes eredeti leírásKevesebb

A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.

The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Bevonási feltételek: The main inclusion criteria include but are not limited to the following:; Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (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; Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART); Participants 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.

Kizáró feltételek: Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma; 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 ongoing corticosteroid therapy; Has a history of transformation of indolent disease to DLBCL; 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; Known additional malignancy that is progressing or has required active treatment within the past 2 years; Has active autoimmune disease that has required systemic treatment in the past 2 years; Has active infection requiring systemic therapy; Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection; Has history of stem cell/solid organ transplant; The main exclusion criteria include but are not limited to the following:; Has Ann Arbor Stage I DLBCL; Has clinically significant pericardial or pleural effusion; Has ongoing Grade >1 peripheral neuropathy; Known active central nervous system (CNS) lymphoma.

ClinicalTrials.gov NCT06890884 · EU CTIS 2024-515526-89-00