RecruitingPhase 3NCT05929222

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

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

190 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Italian study compares radiation therapy alone versus radiation therapy combined with obinutuzumab (an immune-boosting antibody) for people with early-stage follicular lymphoma, a slow-growing type of blood cancer, to see if adding the drug improves outcomes. **You may be eligible if...** - You are 18 or older with confirmed grade I–IIIA follicular lymphoma - Your lymphoma is early stage (stage I or II, non-bulky, smaller than 7 cm) - You have not received any prior treatment for lymphoma (except steroids) - You have adequate kidney and liver function - Your bone marrow biopsy is negative for lymphoma involvement **You may NOT be eligible if...** - Your lymphoma is a more aggressive grade (IIIb) - Your disease is more advanced (stage III or higher) or has "B symptoms" - You have HIV, active hepatitis B or C - You have a history of another cancer in the past 3 years - You are pregnant or breastfeeding - You are currently enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

Involved-Site Radiation Therapy 24Gy

OTHERRadiotherapy plus Obinutuzumab

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

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

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

Naples, Italy

Azienda Ospedaliero-Universitaria Maggiore Della Carita, SCDU Ematologia

Novara, Italy

Istituto Oncologico Veneto, UOC Oncologia 1

Padova, 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

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NCT05929222

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