Patologia: Linfomi
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: II
Linee di trattamento: Prima linea
Criteri di inclusione:
The main inclusion criteria include but are not limited to the following:
- Has histologically confirmed diagnosis of DLBCL by prior biopsy
- Has positron emission tomography (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.
Criteri di esclusione:
The main 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.
Trattamento sperimentale:
BIOLOGICAL: Zilovertamab Vedotin
DRUG: Cyclophosphamide
DRUG: Doxorubicin
BIOLOGICAL: Rituximab
BIOLOGICAL: Rituximab Biosimilar
DRUG: Prednisone
DRUG: Prednisolone
Trattamento di controllo:
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AO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL
Riferimento: Prof. Marco Ladetto
Telefono: 0131206262
Email: marco.ladetto@ospedale.al.it
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Unità Linfomi
Riferimento: Dr. Andrés J.M. Ferreri
Email: ferreri.andres@hsr.it
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
SOD Ematologia
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Istituto di Ematologia
AO “V. Cervello”
Via Trabucco 180 - 90146 Palermo - PA
Ematologia I
Numero di iscrizione a registro: 2021-005861-41
Data di inserimento: 03.10.2023
Merck Sharp & Dohme LLC
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Riferimento: Dr. Informazione non disponibile
Telefono: 00000
Email: nd@nd.it
Localita: Roma