El propósito de este estudio es evaluar si zilovertamab vedotin combinado con el tratamiento estándar puede ayudar a las personas a vivir más tiempo sin que el cáncer crezca o se disemine, en comparación con quienes reciben únicamente el tratamiento estándar.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

biological

Rituximab Biosimilar

IV infusion

drug

Prednisone

Per Approved Product Label

drug

Prednisolone

Oral administration

drug

Vincristine

IV infusion

drug

Rescue medication

Participants receive rescue medication at the investigator's discretion, per approved product label. The recommended rescue medication is granulocyte colony-stimulating factor (G-CSF).

biological

Zilovertamab vedotin

IV infusion

biological

Rituximab

IV infusion

drug

Cyclophosphamide

IV infusion

drug

Doxorubicin

IV infusion

Ubicaciones

Clinica Adventista Belgrano ( Site 0309)

Caba., Buenos Aires, Argentina

Study Coordinator · +5491140141500

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +542234963224

RECRUITING

Hospital Universitario Austral ( Site 0307)

Pilar, Buenos Aires, Argentina

Study Coordinator · +541158239252

RECRUITING

Hospital Aleman ( Site 0301)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +541148232574

RECRUITING

Fundacion Estudios Clinicos ( Site 0311)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +54 (0341) 2221472

RECRUITING

C.I.C.E. 9 de Julio ( Site 0305)

San Miguel de Tucumán, Tucumán Province, Argentina

Study Coordinator · 0381 450-4512

RECRUITING

Hospital Italiano de Buenos Aires ( Site 0304)

CABA, Argentina

Study Coordinator · (011) 4959-0550

RECRUITING

Clinica EL Castaño ( Site 0312)

San Juan, Argentina

COMPLETED

Estudio de fase 3, aleatorizado, abierto, multicéntrico de zilovertamab vedotin (MK-2140) en combinación con R-CHP versus R-CHOP en participantes con linfoma difuso de células B grandes (LDCBG) no tratado previamente (waveLINE-010)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Rituximab Biosimilar

Prednisone

Prednisolone

Vincristine

Rescue medication

Zilovertamab vedotin

Rituximab

Cyclophosphamide

Doxorubicin

Ubicaciones

Clinica Adventista Belgrano ( Site 0309)

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)

Hospital Universitario Austral ( Site 0307)

Hospital Aleman ( Site 0301)

Fundacion Estudios Clinicos ( Site 0311)

C.I.C.E. 9 de Julio ( Site 0305)

Hospital Italiano de Buenos Aires ( Site 0304)

Clinica EL Castaño ( Site 0312)

Patrocinadores

Contactos

Toll Free Number