Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients
ConditionFollicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS
About this trial
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 criteria
Qualifiers
Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
Histologically documented diagnosis of cFL (CD20+ by flow cytometry or immunohistochemistry) as defined in the International Consensus Classification of Mature Lymphoid Neoplasms (Campo E., 2022) and in the World Health Organization Classification (WHO) 5th edition 2022.
Age ≥18 years.
Relapsed or refractory disease. Histologic confirmation of FL relapse is not mandatory but is highly recommended.
Disqualifiers
Histological diagnosis different from cFL (Campo E., 2022).
R/R FL who were treated with more than three lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy; rituximab maintenance as part of a previous line of therapy should not be considered as a line of therapy; radiotherapy alone or in combination with rituximab is not considered a line of therapy).
Patients with stage I or II (limited stage) suitable for RT alone treatment.
Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor (BTKi).
Trial design
Treatments tested in this trial
- Mosunetuzumab in combination with Zanubrutinib
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov