A phase II trial investigating MOsunetuzumab and ZAnubrutinib (BGB-3111) in Relapsed/refracTory follicular lymphoma patients (MOZART)

Conditions

Follicular lymphoma

Brief summary

CR rate (CRR) at the end of the combination therapy (according to Lugano, 2014 criteria).

Detailed description

ORR, PR rate at the end of the combination therapy (according to Lugano, 2014 criteria)., PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death for any cause., OS defined as the time between the start of prephase and death from any cause., DOR defined as the time from the first documentation of tumor response to disease progression or death from any cause., DOCR defined as the time from the first documentation of tumor complete response to disease progression or death from any cause., TTNT defined as the time between the start of the prephase and the initiation of the next line of therapy., EFS defined as the time from the start of the prephase to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference, or initiation, of a new treatment without documented progression)., Frequency and severity of AEs and SAEs classified as per latest version of CTCAE., Frequency and severity of cytokine release syndrome (CRS) and Neurological Adverse Events (NAE) will be evaluated according the ASTCT Grading Criteria.

Rita Tavarozzi, Marco Ladetto, Francesca Bonello, Umberto Vitolo, Pier Luigi Zinzani et al. (10 authors)

Blood2025-11-03

10.1182/blood-2025-7096

Mosunetuzumab and Zanubrutinib in Relapsed/Refractory Follicular Lymphoma Patients (MOZART): A Phase II, Chemo-Free Trial from Fondazione Italiana Linfomi (FIL)

Marco Ladetto, Rita Tavarozzi, Matthew Ku, Luca Arcaini, Carola Boccomini et al. (12 authors)

Blood2024-11-051 citations

10.1182/blood-2024-201305

Interventions

DRUGBRUKINSA 80 mg hard capsules

DRUGMosunetuzumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CR rate (CRR) at the end of the combination therapy (according to Lugano, 2014 criteria).	—

Secondary

Measure	Time frame
ORR, PR rate at the end of the combination therapy (according to Lugano, 2014 criteria)., PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death for any cause., OS defined as the time between the start of prephase and death from any cause., DOR defined as the time from the first documentation of tumor response to disease progression or death from any cause., DOCR defined as the time from the first documentation of tumor complete response to disease progression or death from any cause., TTNT defined as the time between the start of the prephase and the initiation of the next line of therapy., EFS defined as the time from the start of the prephase to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference, or initiation, of a new treatment without documented progression)., Frequency and severity of AEs and SAEs classified as per latest version of CTCAE., Frequency and seve	—

Measure

Time frame

ORR, PR rate at the end of the combination therapy (according to Lugano, 2014 criteria)., PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death for any cause., OS defined as the time between the start of prephase and death from any cause., DOR defined as the time from the first documentation of tumor response to disease progression or death from any cause., DOCR defined as the time from the first documentation of tumor complete response to disease progression or death from any cause., TTNT defined as the time between the start of the prephase and the initiation of the next line of therapy., EFS defined as the time from the start of the prephase to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference, or initiation, of a new treatment without documented progression)., Frequency and severity of AEs and SAEs classified as per latest version of CTCAE., Frequency and seve

—

Countries

Italy

Outcome results

None listed