Actively Recruiting
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi
Led by Fondazione Italiana Linfomi - ETS · Updated on 2025-12-24
190
Participants Needed
48
Research Sites
380 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinutuzumab.
CONDITIONS
Official Title
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of Follicular Lymphoma grade I-IIIA according to WHO 2017
- Ann Arbor Stage IA or IIA (single radiation field), or IE, non-bulky (<7 cm) determined by PET/CT scan
- PET scan before surgery acceptable without repeat after surgery
- No prior treatment except steroid pre-treatment
- FLIPI score less than 2 and FLIPI2 score less or equal to 2
- Age 18 years or older
- Negative bone marrow biopsy
- Centralized PCR assessment of BCL2/IGH positive cells in blood and bone marrow
- Central review of lymph node biopsy with FISH for t(14;18)
- ECOG performance status 0 to 2
- At least one measurable nodal disease site ≥2.0 cm by CT or ultrasound
- Adequate renal function with creatinine clearance ≥40 mL/min
- Adequate liver function: AST and ALT ≤3.0 times upper normal limit, bilirubin ≤1.5 times UNL unless due to non-hepatic cause
- Signed informed consent approved by ethics committee
- Ability to adhere to study visits and protocol
- Life expectancy of at least 3 months
- Women must be postmenopausal for ≥1 year, surgically sterile, or practicing effective contraception during and 18 months after treatment
- Negative pregnancy test for women of childbearing potential
- Men with partners of childbearing potential must use effective contraception or abstain during treatment and 3 months after
- Men surgically sterilized must use barrier contraception or abstain during treatment and 3 months after
You will not qualify if you...
- Follicular Lymphoma grade IIIb
- Stage higher than II, presence of B symptoms, or bulky disease (>7 cm)
- Stage II with distant sites outside a single radiation field
- Primary cutaneous follicular lymphoma
- Known HIV positive status
- Positive hepatitis C antibody test confirmed by RNA test if applicable
- Positive hepatitis B surface antigen or positive HBV DNA if core antibody positive
- Central Nervous System involvement by lymphoma
- Significant neurological, psychiatric, endocrine, metabolic, immunologic, or hepatic disease interfering with consent or participation
- Other active malignancies within 3 years except certain treated skin or cervical cancers
- Uncontrolled active infections or hepatitis B/C requiring treatment
- Pregnant or breastfeeding women
- Participation in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo, SCDU Ematologia
Alessandria, Italy
Actively Recruiting
2
AORN San Giuseppe Moscati Avellino, U.O.C. Ematologia e Trapianto Emopoietico
Avellino, Italy
Actively Recruiting
3
Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
Aviano, Italy
Actively Recruiting
4
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari, Italy
Actively Recruiting
5
Ospedale degli Infermi di Biella, SSD Ematologia
Biella, Italy
Actively Recruiting
6
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, U.O. Ematologia
Brescia, Italy
Actively Recruiting
7
ARNAS G. Brotzu, SC Ematologia e CTMO
Cagliari, Italy
Not Yet Recruiting
8
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Oncologia Medica
Candiolo, Italy
Actively Recruiting
9
Istituto Oncologico Veneto, U.O.C. Oncoematologia
Castelfranco Veneto, Italy
Actively Recruiting
10
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, UOC Ematologia
Catania, Italy
Not Yet Recruiting
11
Azienda Ospedaliera Santa Croce E Carle, S.C. di Ematologia
Cuneo, Italy
Actively Recruiting
12
Careggi University Hospital, SOD Ematologia
Florence, Italy
Actively Recruiting
13
Ssd Ematologia ASLTO4, S.S.D. Ematologia
Ivrea, Italy
Not Yet Recruiting
14
Ospedale Santa Maria Goretti, SOD Ematologia
Latina, Italy
Actively Recruiting
15
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Oncoematologia
Meldola, Italy
Actively Recruiting
16
Azienda Ospedali Riuniti Papardo-Piemonte, U.O. Ematologia
Messina, Italy
Actively Recruiting
17
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Milan, Italy
Actively Recruiting
18
Fondazione IRCCS Istituto Nazionale Dei Tumori, S.C. Ematologia e Trapianto Midollo Osseo Allogenico
Milan, Italy
Actively Recruiting
19
Ospedale San Raffaele S.r.l., Unitа Linfomi - Dipartimento Oncoematologia
Milan, Italy
Actively Recruiting
20
Azienda Ospedaliero Universitaria Di Modena, S.C. Ematologia
Modena, Italy
Actively Recruiting
21
Azienda Ospedaliera S Gerardo Di Monza, Ematologia
Monza, Italy
Actively Recruiting
22
Azienda Ospedaliera Universitaria Federico II Di Napoli, U.O.C. di Ematologia e Trapianti di Midollo
Naples, Italy
Actively Recruiting
23
Azienda Ospedaliero-Universitaria Maggiore Della Carita, SCDU Ematologia
Novara, Italy
Actively Recruiting
24
Istituto Oncologico Veneto, UOC Oncologia 1
Padova, Italy
Actively Recruiting
25
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Oncoematologia
Palermo, Italy
Actively Recruiting
26
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, U.O.C. Ematologia
Palermo, Italy
Not Yet Recruiting
27
Fondazione IRCCS Policlinico San Matteo, U.O.C. Ematologia I
Pavia, Italy
Not Yet Recruiting
28
Hospital Santa Maria Della Misericordia, S.C. di Ematologia con TMO
Perugia, Italy
Not Yet Recruiting
29
Azienda Unità Sanitaria Locale Di Piacenza, U.O.Ematologia
Piacenza, Italy
Actively Recruiting
30
Azienda Ospedaliero Universitaria Pisana, U.O. Ematologia
Pisa, Italy
Actively Recruiting
31
Azienda Unita Sanitaria Locale Della Romagna, U.O.C. Ematologia
Ravenna, Italy
Actively Recruiting
32
Azienda USL IRCCS Di Reggio Emilia, S.C. Ematologia
Reggio Emilia, Italy
Actively Recruiting
33
Azienda Unita Sanitaria Locale Della Romagna, U.O. di Ematologia
Rimini, Italy
Actively Recruiting
34
ASL Roma 1, UOSD Ematologia
Roma, Italy
Actively Recruiting
35
Azienda Ospealiero Universitaria Policlinico Umberto I, Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma, Italy
Actively Recruiting
36
Azienda Ospedaliera S Giovanni Addolorata, UOC Ematologia
Roma, Italy
Not Yet Recruiting
37
Azienda Ospedaliero-Universitaria Sant Andrea, UOC Ematologia
Roma, Italy
Actively Recruiting
38
Catholic University Of Sacred Heart, UOC Ematologia e Trapianto di cellule staminali emopoietiche
Roma, Italy
Actively Recruiting
39
Fondazione Policlinico Universitario Campus Bio-Medico, UOC di Ematologia e Trapianto di Cellule Staminali
Roma, Italy
Actively Recruiting
40
I.F.O. Istituti Fisioterapici Ospitalieri, UOSD Ematologia e Trapianto
Roma, Italy
Actively Recruiting
41
Ospedale Di Sassuolo S.p.A., U.O.S.D. di Oncologia
Sassuolo, Italy
Actively Recruiting
42
Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia
Siena, Italy
Actively Recruiting
43
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario, Medicina Interna
Sondrio, Italy
Actively Recruiting
44
Azienda Ospedaliera S Maria Di Terni, S.C. Oncoematologia
Terni, Italy
Not Yet Recruiting
45
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana, S.C di Ematologia
Treviso, Italy
Actively Recruiting
46
Azienda Sanitaria Universitaria Friuli Centrale, SOC Clinica Ematologica
Udine, Italy
Actively Recruiting
47
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi, U.O.C Ematologia
Varese, Italy
Not Yet Recruiting
48
Azienda Ospedaliera Universitaria Integrata Verona, U.O.C. Ematologia
Verona, 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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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