Phase
Condition
Lymphoma
Treatment
Prednisone
Zilovertamab Vedotin
Rituximab Biosimilar
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion:
Has histologically confirmed diagnosis of DLBCL by prior biopsy
Has PET-positive disease verified by blinded independent central review (BICR) at screening, defined as 4-5 on the Lugano response criteria 5-point scale
Has received no prior treatment for DLBCL
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days prior to the start of study intervention
Exclusion:
Has a history of transformation of indolent disease to DLBCL
Has received solid organ transplant at any time
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
Has clinically significant (ie, 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 pericardial effusion or clinically significant pleural effusion
Has ongoing Grade >1 peripheral neuropathy
Has a demyelinating form of Charcot-Marie-Tooth disease
History of a second malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 2 years with the exception of participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
Has received prior radiotherapy within 28 days of start of study intervention
Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor until <30 days after the last dose
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study intervention
Has known active central nervous system (CNS) lymphoma
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known active hepatitis C virus infection
Has a known active hepatitis B virus infection
Study Design
Connect with a study center
BC Cancer Victoria-Clinical Trials Unit ( Site 0105)
Victoria, British Columbia V8R 6V5
CanadaSite Not Available
William Osler Health System ( Site 0106)
Toronto, Ontario L6R3J7
CanadaSite Not Available
Hopital du Sacre-Coeur de Montreal ( Site 0108)
Montreal, Quebec H4J 1C5
CanadaSite Not Available
Hadassah Medical Center ( Site 0401)
Jerusalem, 9112001
IsraelSite Not Available
Sheba Medical Center-Hemato Oncology ( Site 0400)
Ramat Gan, 5265601
IsraelSite Not Available
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0306)
Roma, Lazio 00168
ItalySite Not Available
Ospedale San Raffaele-Unità Linfomi ( Site 0305)
Milano, Lombardia 20132
ItalySite Not Available
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0307)
Palermo, Sicilia 90146
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi-SOD Ematologia ( Site 0308)
Firenze, Toscana 50134
ItalySite Not Available
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
Alessandria, 15121
ItalySite Not Available
Samsung Medical Center ( Site 0200)
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital ( Site 0201)
Seoul, 03080
Korea, Republic ofSite Not Available
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 0503)
Łódź, Lodzkie 93-513
PolandSite Not Available
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
Warszawa, Mazowieckie 02-781
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0504)
Gdańsk, Pomorskie 80-214
PolandSite Not Available
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0505)
Gliwice, Slaskie 44-101
PolandSite Not Available
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Hematology ( Site 0704)
Sevilla, Andalucia 41013
SpainSite Not Available
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0703)
L'Hospitalet Del Llobregat, Barcelona 08908
SpainSite Not Available
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0700)
Madrid, 28040
SpainSite Not Available
Mega Medipol-Hematology ( Site 0808)
Stanbul, Istanbul 34214
TurkeySite Not Available
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 0801)
Ankara, 06620
TurkeySite Not Available
Trakya University ( Site 0805)
Edirne, 22030
TurkeySite Not Available
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