RecruitingPhase 2NCT06492837

Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients

A Phase II Trial Investigating MOsunetuzumab and ZAnubrutinib (BGB-3111) in Relapsed/refracTory Follicular Lymphoma Patients (MOZART)

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

56 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma

Summary

This is a Phase 2, multicenter study evaluating the efficacy and safety of mosunetuzumab + zanubrutinib (M+Z) used as salvage strategy in patients with R/R FL who have received at least one line of prior systemic therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two targeted medicines — mosunetuzumab (a bispecific antibody) and zanubrutinib (a BTK inhibitor pill) — for people with follicular lymphoma whose cancer has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with follicular lymphoma (a slow-growing blood cancer) that has returned or is no longer responding to treatment - You have received 1 to 3 prior treatment regimens that included an anti-CD20 antibody (like rituximab) - You are 18 or older - Your cancer is measurable on a scan - Your blood counts, kidney, and liver function meet minimum thresholds - You are able to swallow capsules or tablets **You may NOT be eligible if...** - You have received more than 3 prior lines of treatment - You have previously been treated with a BTK inhibitor or a bispecific antibody targeting CD20 and CD3 - You have a history of the lymphoma transforming into a more aggressive type - You have had a prior stem cell transplant from a donor - You have active autoimmune disease, active hepatitis B or C, or HIV - You are pregnant or breastfeeding - You have serious heart, lung, or bleeding problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMosunetuzumab in combination with Zanubrutinib

Combinations of Mosunetuzumab and Zanubrutinib as salvage strategy in patients with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Locations(24)

Royal Adelaide Hospital

Adelaide, Australia

Liverpool Hospital

Liverpool, Australia

St. Vincent Hospital Melbourne

Melbourne, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Fondazione del Piemonte per l'Oncologia - IRCCS, Ematologia

Candiolo, Torino, Italy

AOU SS. Antonio e Biagio e Cesare Arrigo, SCDU Ematologia

Alessandria, Italy

AOU Ospedali Riuniti, Clinica di Ematologia

Ancona, Italy

Azienda Ospedaliera S.Giuseppe Moscati, S.C. Ematologia e Trapianto emopoietico

Avellino, Italy

IRCCS Istituto Tumori Giovanni Paolo II, U.O.C Ematologia

Bari, Italy

Policlinico S.Orsola-Malpighi, Istituto di Ematologia "Seragnoli"

Bologna, Italy

ASST Spedali Civili di Brescia, Ematologia

Brescia, Italy

Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia

Catania, Italy

Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia

Florence, Italy

ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori, Ematologia

Monza, Italy

AOU Maggiore della Carità di Novara, SCDU Ematologia

Novara, Italy

A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia

Palermo, Italy

Azienda USL Piacenza, UOC Ematologia e Centro Trapianti

Piacenza, Italy

Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia

Reggio Emilia, Italy

Ospedale degli Infermi di Rimini, U.O. di Ematologia

Rimini, Italy

Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione

Roma, Italy

A.O.U. Città della Salute e della Scienza di Torino, S.C.Ematologia

Torino, Italy

Ospedale Ca' Foncello, S.C di Ematologia

Treviso, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06492837

Related Trials

A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT01804686175 locations

A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma

NCT060433231 location

Clonal Evolution in Follicular Lymphoma

NCT031909281 location

A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma

NCT0459464227 locations

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

NCT049896213 locations