Actively Recruiting
Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients
Led by Fondazione Italiana Linfomi - ETS · Updated on 2026-01-28
56
Participants Needed
24
Research Sites
464 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and comply with study requirements
- Histologically confirmed diagnosis of follicular lymphoma (CD20+)
- Age 18 years or older
- Relapsed or refractory follicular lymphoma
- Received 1 to 3 prior systemic therapies including an anti-CD20 antibody
- Follicular lymphoma requiring systemic therapy based on tumor size or criteria
- ECOG performance status 0 to 2
- Availability of histological material for review
- At least one measurable or evaluable disease site by CT or FDG-PET
- Adequate blood counts: ANC > 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 9 g/dL
- Adequate kidney function (creatinine clearance ≥ 40 mL/min)
- Adequate liver function within specified limits
- Able to adhere to study visits and protocol
- Able to swallow capsules or tablets
- Women must be postmenopausal, surgically sterile, or use effective contraception
- Women of childbearing potential must have a negative pregnancy test
- Men must agree to use contraception during and shortly after treatment
You will not qualify if you...
- Diagnosis other than follicular lymphoma
- More than three prior lines of treatment for relapsed/refractory follicular lymphoma
- Stage I or II disease suitable for radiotherapy alone
- Prior treatment with Bruton's tyrosine kinase inhibitors or anti-CD20xCD3 bispecific antibodies
- Need for anticoagulation with warfarin or equivalent
- History of transformation to aggressive lymphoma
- Prior allogeneic stem cell transplant
- History of severe bleeding disorders or recent stroke
- Life expectancy less than 6 months
- History of progressive multifocal leukoencephalopathy or hemophagocytic lymphohistiocytosis
- History of specified autoimmune diseases
- Central nervous system lymphoma or involvement
- Recent anti-cancer therapy within 14 days prior to study
- Prior CAR-T therapy within 90 days
- Significant uncontrolled cardiovascular disease
- Significant neurologic, psychiatric, metabolic, immunologic, or liver disease
- Recent other active malignancies except certain treated cases
- Active infections including untreated hepatitis or HIV
- Pregnancy or breastfeeding
- Severe pulmonary disease
- Inability to swallow capsules or significant gastrointestinal disease
- Medical conditions that increase treatment risk or interfere with assessment
- Major surgery within 4 weeks prior to study
- Recent live vaccinations
- Alcohol or drug addiction or psychiatric conditions affecting compliance
- Hypersensitivity to study drugs
- Active autoimmune anemia or thrombocytopenia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Royal Adelaide Hospital
Adelaide, Australia
Actively Recruiting
2
Liverpool Hospital
Liverpool, Australia
Actively Recruiting
3
St. Vincent Hospital Melbourne
Melbourne, Australia
Actively Recruiting
4
Princess Alexandra Hospital
Woolloongabba, Australia
Actively Recruiting
5
Fondazione del Piemonte per l'Oncologia - IRCCS, Ematologia
Candiolo, Torino, Italy
Actively Recruiting
6
AOU SS. Antonio e Biagio e Cesare Arrigo, SCDU Ematologia
Alessandria, Italy
Actively Recruiting
7
AOU Ospedali Riuniti, Clinica di Ematologia
Ancona, Italy
Actively Recruiting
8
Azienda Ospedaliera S.Giuseppe Moscati, S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
Actively Recruiting
9
IRCCS Istituto Tumori Giovanni Paolo II, U.O.C Ematologia
Bari, Italy
Actively Recruiting
10
Policlinico S.Orsola-Malpighi, Istituto di Ematologia "Seragnoli"
Bologna, Italy
Actively Recruiting
11
ASST Spedali Civili di Brescia, Ematologia
Brescia, Italy
Actively Recruiting
12
Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia
Catania, Italy
Actively Recruiting
13
Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia
Florence, Italy
Actively Recruiting
14
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Milan, Italy
Actively Recruiting
15
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia
Milan, Italy
Actively Recruiting
16
Fondazione IRCCS San Gerardo dei Tintori, Ematologia
Monza, Italy
Actively Recruiting
17
AOU Maggiore della Carità di Novara, SCDU Ematologia
Novara, Italy
Actively Recruiting
18
A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia
Palermo, Italy
Actively Recruiting
19
Azienda USL Piacenza, UOC Ematologia e Centro Trapianti
Piacenza, Italy
Actively Recruiting
20
Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia
Reggio Emilia, Italy
Actively Recruiting
21
Ospedale degli Infermi di Rimini, U.O. di Ematologia
Rimini, Italy
Actively Recruiting
22
Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione
Roma, Italy
Actively Recruiting
23
A.O.U. Città della Salute e della Scienza di Torino, S.C.Ematologia
Torino, Italy
Not Yet Recruiting
24
Ospedale Ca' Foncello, S.C di Ematologia
Treviso, Italy
Actively Recruiting
Research Team
U
Uffici Studi FIL
CONTACT
U
Uffici Studi FIL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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