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Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi

An Open-label, Randomized Phase III Trial Comparing Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi

NCT05929222•Fondazione Italiana Linfomi - ETS

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage (I-II non-bulky). 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histological documented diagnosis of Follicular Lymphoma grade I-IIIA as defined in the 2017 edition of World Health Organization (WHO)
•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
+19 more criteria

Exclusion Criteria

•1. Histological diagnosis of Follicular lymphoma grade IIIb
•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
+5 more criteria

Locations (48)

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

Key Dates

Start Date

December 14, 2023

Primary Completion Date

April 1, 2031

Completion Date

April 1, 2031

Last Updated

December 24, 2025

Enrollment

190

ESTIMATED participants

Conditions

Follicular Lymphoma

Interventions

Radiotherapy

RADIATION

Radiotherapy plus Obinutuzumab

OTHER

Contacts

Uffici Studi FIL

CONTACT

+390131033153 startup@filinf.it

Uffici Studi FIL

CONTACT

+390599769913 gestionestudi@filinf.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi

Inclusion Criteria

Exclusion Criteria

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