GO45434 - A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

Studio Clinico

Patologia: Linfomi, Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Life expectancy ≥ 12 weeks
- Histologically confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS)
- Relapsed / refractory disease
- At least one prior line of systemic therapy - Participants may have undergone ASCT prior to recruitment - Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
- Participants who have failed one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant
- At least one bi-dimensionally measurable ( > 1.5 cm) nodal lesion, or one bi-dimensionally measurable ( > 1 cm) extranodal lesion, as measured on CT scan.

Criteri di esclusione: 

- Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
- History of transformation of indolent disease to DLBCL
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
- Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products.

Trattamento sperimentale: 

glofitamab+gemcitabina+oxaliplatino

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-516791-15-00

Data di inserimento: 07.07.2025

Promotore

Hoffmann-La Roche

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na