Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi
NCT ID: NCT05929222
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
190 participants
INTERVENTIONAL
2023-12-14
2031-04-30
Brief Summary
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Detailed Description
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Patients will be randomized to receive:
\- Involved-Site Radiation Therapy at standard dose 24Gy - standard arm
OR
\- Involved-Site Radiation Therapy at standard dose 24Gy followed by Obinutuzumab 4 infusions weekly + 4 infusions every 3 weeks (8 total doses) - experimental arm
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Arm
Radiotherapy alone
Radiotherapy
Involved-Site Radiation Therapy 24Gy
Experimental Arm
Radiotherapy plus Obinutuzumab
Radiotherapy plus Obinutuzumab
Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses weekly plus addition 4 doses every 3 weeks
Interventions
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Radiotherapy
Involved-Site Radiation Therapy 24Gy
Radiotherapy plus Obinutuzumab
Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses weekly plus addition 4 doses every 3 weeks
Eligibility Criteria
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Inclusion Criteria
2. Ann Arbor Stage IA or IIA (includible in one radiation field), or IE, non-bulky (\<7 cm). Stage must be determined by PET/CT scan (Appendix 2)
3. Patients performing PET before surgery can also be enrolled without repeating PET after surgery
4. No previous treatment except for steroid pre-treatment
5. FLIPI \< 2, FLIPI2 ≤ 2
6. Age ≥ 18 years
7. Negative bone marrow biopsy
8. Qualitative/quantitative PCR centralized assessment of BCL2/IGH positive cells in peripheral blood (PB), bone marrow (BM).
9. Centralized revision of the lymph node biopsy with FISH for t(14;18)
10. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
11. At least one site of measurable nodal disease pre-biopsy ≥ 2.0 cm in the longest transverse diameter as determined by CT scan or ultrasonography
12. Adequate renal function defined as follows:
* Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
13. Adequate hepatic function per local laboratory reference range as follows:
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x UNL
* Bilirubin ≤1.5 x UNL (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
14. Subject understands and voluntarily signs an informed consent form approved by an Independent National Ethics Committee (NEC), prior to the initiation of any screening or study-specific procedures
15. Subject must be able to adhere to the study visit schedule and other protocol requirements
16. Life expectancy ≥ 3 months
17. Fertility and pregnancy prevention criteria
* Women must be:
* postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)
* surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
* completely abstinent (periodic abstinence from intercourse is not permitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be pre-pared to continue birth control measures for at least 18 months after terminating treatment.
* Women of childbearing potential must have a negative pregnancy test at screening
* Men with female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study treatment. Men must refrain from donating sperm for the same period
* Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following
* practice effective barrier contraception during the entire study treatment period and through 3 months after the last dose of study drug, or
* agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception)
Exclusion Criteria
2. Staging \>II or B symptoms or bulky disease (\> 7 cm)
3. Stage II with distant involved sites, not includible in a single radiation field
4. Primary cutaneous follicular lymphoma
5. Known HIV positivity
6. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RNA on the same sample to confirm the result, if negative, the patient is eligible.
7. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a quantitative HBVDNA test will be performed and if positive the subject will be excluded. Patients with HBcAb positivity and negative HBV DNA should be prophylactically treated with oral Lamivudine (100 mg /day). Note: subjects with serologic evidence of prior vaccination to HBV (i.e., hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
8. Central Nervous System (CNS) involvement with lymphoma
9. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
10. Any history of other active malignancies within 3 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent
11. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
* Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
* Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment.
12. If female, the patient is pregnant or breast-feeding
13. Patients participating in other clinical studies.
18 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Alessandro Pulsoni, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Santa Maria Goretti Latina
Andrea Filippi, MD
Role: PRINCIPAL_INVESTIGATOR
Università di Pavia-Fondazione IRCCS Policlinico San Matteo
Locations
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Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo, SCDU Ematologia
Alessandria, , Italy
AORN San Giuseppe Moscati Avellino, U.O.C. Ematologia e Trapianto Emopoietico
Avellino, , Italy
Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
Aviano, , Italy
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari, , Italy
Ospedale degli Infermi di Biella, SSD Ematologia
Biella, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, U.O. Ematologia
Brescia, , Italy
ARNAS G. Brotzu, SC Ematologia e CTMO
Cagliari, , Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Oncologia Medica
Candiolo, , Italy
Istituto Oncologico Veneto, U.O.C. Oncoematologia
Castelfranco Veneto, , Italy
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, UOC Ematologia
Catania, , Italy
Azienda Ospedaliera Santa Croce E Carle, S.C. di Ematologia
Cuneo, , Italy
Careggi University Hospital, SOD Ematologia
Florence, , Italy
Ssd Ematologia ASLTO4, S.S.D. Ematologia
Ivrea, , Italy
Ospedale Santa Maria Goretti, SOD Ematologia
Latina, , Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Oncoematologia
Meldola, , Italy
Azienda Ospedali Riuniti Papardo-Piemonte, U.O. Ematologia
Messina, , Italy
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Milan, , Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori, S.C. Ematologia e Trapianto Midollo Osseo Allogenico
Milan, , Italy
Ospedale San Raffaele S.r.l., Unitа Linfomi - Dipartimento Oncoematologia
Milan, , Italy
Azienda Ospedaliero Universitaria Di Modena, S.C. Ematologia
Modena, , Italy
Azienda Ospedaliera S Gerardo Di Monza, Ematologia
Monza, , Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli, U.O.C. di Ematologia e Trapianti di Midollo
Napoli, , Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita, SCDU Ematologia
Novara, , Italy
Istituto Oncologico Veneto, UOC Oncologia 1
Padua, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Oncoematologia
Palermo, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, U.O.C. Ematologia
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo, U.O.C. Ematologia I
Pavia, , Italy
Hospital Santa Maria Della Misericordia, S.C. di Ematologia con TMO
Perugia, , Italy
Azienda Unità Sanitaria Locale Di Piacenza, U.O.Ematologia
Piacenza, , Italy
Azienda Ospedaliero Universitaria Pisana, U.O. Ematologia
Pisa, , Italy
Azienda Unita Sanitaria Locale Della Romagna, U.O.C. Ematologia
Ravenna, , Italy
Azienda USL IRCCS Di Reggio Emilia, S.C. Ematologia
Reggio Emilia, , Italy
Azienda Unita Sanitaria Locale Della Romagna, U.O. di Ematologia
Rimini, , Italy
ASL Roma 1, UOSD Ematologia
Roma, , Italy
Azienda Ospealiero Universitaria Policlinico Umberto I, Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma, , Italy
Azienda Ospedaliera S Giovanni Addolorata, UOC Ematologia
Roma, , Italy
Azienda Ospedaliero-Universitaria Sant Andrea, UOC Ematologia
Roma, , Italy
Catholic University Of Sacred Heart, UOC Ematologia e Trapianto di cellule staminali emopoietiche
Roma, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico, UOC di Ematologia e Trapianto di Cellule Staminali
Roma, , Italy
I.F.O. Istituti Fisioterapici Ospitalieri, UOSD Ematologia e Trapianto
Roma, , Italy
Ospedale Di Sassuolo S.p.A., U.O.S.D. di Oncologia
Sassuolo, , Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia
Siena, , Italy
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario, Medicina Interna
Sondrio, , Italy
Azienda Ospedaliera S Maria Di Terni, S.C. Oncoematologia
Terni, , Italy
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana, S.C di Ematologia
Treviso, , Italy
Azienda Sanitaria Universitaria Friuli Centrale, SOC Clinica Ematologica
Udine, , Italy
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi, U.O.C Ematologia
Varese, , Italy
Azienda Ospedaliera Universitaria Integrata Verona, U.O.C. Ematologia
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Manuela Zanni, MD
Role: primary
Sonya De Lorenzo, MD
Role: primary
Michele Spina, MD
Role: primary
Carla Minoia, MD
Role: primary
Annarita Conconi, MD
Role: primary
Antonella Anastasia, MD
Role: primary
Roberta Murru, MD
Role: primary
Francesca Bonello, MD
Role: primary
Nilla Maschio, MD
Role: primary
Annalisa Chiarenza, MD
Role: primary
Elia Boccellato, MD
Role: primary
Luca Nassi, MD
Role: primary
Chiara Ciochetto, MD
Role: primary
Alessandro Pulsoni, MD
Role: primary
Francesco Malaspina, MD
Role: primary
Donato Mannina, MD
Role: primary
Vittorio Ruggero Zilioli, MD
Role: primary
Paolo Corradini, MD
Role: primary
Andrés Ferreri, MD
Role: primary
Giovanna Leonardi, MD
Role: primary
Silvia Bolis, MD
Role: primary
Fabrizio Pane, MD
Role: primary
Gloria Margiotta, MD
Role: primary
Dario Marino, MD
Role: primary
Caterina Patti, MD
Role: primary
Salvatrice Mancuso, MD
Role: primary
Luca Arcaini, MD
Role: primary
Flavio Falcinelli, MD
Role: primary
Patrizia Bernuzzi, MD
Role: primary
Sara Galimberti, MD
Role: primary
Monica Tani, MD
Role: primary
Stefano Luminari, MD
Role: primary
Melania Celli, MD
Role: primary
Tommaso Caravita di Toritto, MD
Role: primary
Ilaria Del Giudice, MD
Role: primary
Paola Anticoli Borza, MD
Role: primary
Agostino Tafuri, MD
Role: primary
Stefan Hohaus, MD
Role: primary
Ombretta Annibali, MD
Role: primary
Daniela Renzi, MD
Role: primary
Sara Bigliardi, MD
Role: primary
Emanuele Cencini, MD
Role: primary
Andrea Maria Soccodato, MD
Role: primary
Anna Maria Liberati, MD
Role: primary
Elisabetta Scarpa, MD
Role: primary
Jacopo Oliveri, MD
Role: primary
Michele Merli, MD
Role: primary
Isacco Ferrarini, MD
Role: primary
Other Identifiers
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FIL_GAZEBO
Identifier Type: -
Identifier Source: org_study_id