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)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Linfoma no Hodgkin, Linfoma
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Mariana Bastos Orteiro
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Tycho Baumman
CENTRO INVESTIGADOR
H.U. La Paz
INVESTIGADOR PRINCIPAL
Pilar Gomez Prieto
FECHA DE APERTURA
Febrero, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
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.
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.
CRITERIOS DE EXCLUSIÓN
Has a history of transformation of indolent disease to DLBCL
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
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 Kaposis sarcoma and/or Multicentric Castlemans 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
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 Kaposis sarcoma and/or Multicentric Castlemans Disease.
Has ongoing corticosteroid therapy
DESCRIPCIÓN
To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to PFS per Lugano response criteria as assessed by BICR.
PALABRAS CLAVE
diffuse large b-cell lymphoma (dlbcl), dlbcl, lymphoma
