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MK-2140-007 - A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)

Studio Clinico

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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Centri partecipanti

Nord Italia

AO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Unità Linfomi

Riferimento: Dr. Andrés J.M. Ferreri
Email: ferreri.andres@hsr.it

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
SOD Ematologia

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Istituto di Ematologia

 

Sud Italia e isole

AO “V. Cervello”
Via Trabucco 180 - 90146 Palermo - PA
Ematologia I

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-005861-41

Data di inserimento: 03.10.2023

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Riferimento: Dr. Informazione non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Roma

 

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