Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasm, Residual

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Obinutuzumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Radiotherapy

Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses weekly plus addition 4 doses every 3 weeks

Radiotherapy plus Obinutuzumab

Uffici Studi FIL

Manuela Zanni, MD

Sonya De Lorenzo, MD

Michele Spina, MD

Carla Minoia, MD

Annarita Conconi, MD

Antonella Anastasia, MD

Roberta Murru, MD

Francesca Bonello, MD

Roberto Sartori, MD

Annalisa Chiarenza, MD

Alessia Castellino, MD

Luca Nassi, MD

Chiara Ciochetto, MD

Alessandro Pulsoni, MD

Francesco Malaspina, MD

Donato Mannina, MD

Vittorio Ruggero Zilioli, MD

Paolo Corradini, MD

Andrés Ferreri, MD

Giovanna Leonardi, MD

Silvia Bolis, MD

Fabrizio Pane, MD

Gloria Margiotta, MD

Dario Marino, MD

Caterina Patti, MD

Salvatrice Mancuso, MD

Luca Arcaini, MD

Flavio Falcinelli, MD

Patrizia Bernuzzi, MD

Sara Galimberti, MD

Monica Tani, MD

Stefano Luminari, MD

Melania Celli, MD

Tommaso Caravita di Toritto, MD

Ilaria Del Giudice, MD

Paola Anticoli Borza, MD

Agostino Tafuri, MD

Stefan Hohaus, MD

Ombretta Annibali, MD

Daniela Renzi, MD

Sara Bigliardi, MD

Emanuele Cencini, MD

Andrea Maria Soccodato, MD

Anna Maria Liberati, MD

Elisabetta Scarpa, MD

Jacopo Oliveri, MD

Michele Merli, MD

Isacco Ferrarini, MD

Andrea Filippi, MD

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.

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

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

Time between the randomization to first documentation of recurrence, progression or death from any cause at 2 years

Complete response (CR) rate according to the international criteria (Cheson 2014)

ORR will be defined as the proportion of patients who have a partial or complete response at every treatment phase

Time between the first documentation of Complete Response to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause

Time between the randomization to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause

MRD negativity at end of treatment for positive patients at baseline

Incidence and severity of AEs in both arms according to latest CTCAE criteria

Prognostic and predictive impact on PFS in presence or absence of t(14;18) rearrangement measured by FISH

Prognostic role of conventional MRD (BCL2/IGH rearrangement by ddPCR) and of MRD on plasmatic circulating tumour deoxyribonucleic acid (ctDNA) at different time points for PFS and relapse

Prognostic and predictive value of different threshold of metabolic response expressed as quantitative PET indexes (QPI) at baseline (PET-0), i.e. SUVmax, MTV and TLG;

Prognostic and predictive role of liquid biopsy by DNA sequencing for lymphoma mutations at different time points on PFS and relapse

Prognostic and predictive value of radiomic analysis on PFS, assessed on both CT and PET scans by Machine Learning tools (pyRadiomics);

Correlation of MRD results with the radiomics results and clinical outcomes

Comparison between genotype at diagnosis and at relapse assessed by RNA sequencing (CIBERSORTx)

Evaluation of liquid biopsy as a tool to identity specific mutations predictive for clonal evolution of lymphoma

Roche Pharma AG

Fondazione Italiana Linfomi - ETS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi	NCT05929222	Follicular Lymp...	Radiotherapy Radiotherapy pl...	18 Years -	Fondazione Italiana Linfomi - ETS
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi	NCT05929222	Follicular Lymp...	Radiotherapy Radiotherapy pl...	18 Years -	Fondazione Italiana Linfomi - ETS
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi	NCT05929222	Follicular Lymp...	Radiotherapy Radiotherapy pl...	18 Years -	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for radiotherapy plus obinutuzumab