Follicular LymphomaPhase 3FIL_GAZEBONCT05929222
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi
A Phase 3 study testing Radiotherapy and Radiotherapy plus Obinutuzumab in people with Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 49 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Radiotherapy and Radiotherapy plus Obinutuzumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 49 sitesItaly
- Study dates
- 14 Dec 2023to Apr 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological documented diagnosis of Follicular Lymphoma grade I-IIIA as defined in the 2017 edition of World Health Organization (WHO)
- 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)
- Patients performing PET before surgery can also be enrolled without repeating PET after surgery
- No previous treatment except for steroid pre-treatment
- FLIPI < 2, FLIPI2 ≤ 2
- Age ≥ 18 years
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- Negative bone marrow biopsy
- Qualitative/quantitative PCR centralized assessment of BCL2/IGH positive cells in peripheral blood (PB), bone marrow (BM).
- Centralized revision of the lymph node biopsy with FISH for t(14;18)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- 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
- Adequate renal function defined as follows:
- Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
- 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)
- 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
- Subject must be able to adhere to the study visit schedule and other protocol requirements
- Life expectancy ≥ 3 months
- 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)
Who cannot join
- Histological diagnosis of Follicular lymphoma grade IIIb
- Staging >II or B symptoms or bulky disease (> 7 cm)
- Stage II with distant involved sites, not includible in a single radiation field
- Primary cutaneous follicular lymphoma
- Known HIV positivity
- 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.
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- 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
- Central Nervous System (CNS) involvement with lymphoma
- 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
- 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
- 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.
- If female, the patient is pregnant or breast-feeding
- Patients participating in other clinical studies.
Trial locations and contacts
49 sites in 1 country. Contact the study team or a site near you to ask about taking part.
49 sites in 1 country
Italy49 sites, 49 recruiting
- Recruiting
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo, SCDU Ematologia
Alessandria
Manuela Zanni, MD, manuela.zanni@ospedale.al.it
Manuela Zanni, MD
- Recruiting
AORN San Giuseppe Moscati Avellino, U.O.C. Ematologia e Trapianto Emopoietico
Avellino
Sonya De Lorenzo, MD, sonya.delorenzo@tin.it
Sonya De Lorenzo, MD
- Recruiting
Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
Aviano
Michele Spina, MD, mspina@cro.it
Michele Spina, MD
- Recruiting
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari
Carla Minoia, MD, c.minoia@oncologico.bari.it
Carla Minoia, MD
- Recruiting
Ospedale degli Infermi di Biella, SSD Ematologia
Biella
Annarita Conconi, MD, annarita.conconi@aslbi.piemonte.it
Annarita Conconi, MD
- Recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, U.O. Ematologia
Brescia
Antonella Anastasia, MD, antonella.anastasia@gmail.com
Antonella Anastasia, MD
- Not yet recruiting
ARNAS G. Brotzu, SC Ematologia e CTMO
Cagliari
Roberta Murru, MD, roberta.murru@aob.it
Roberta Murru, MD
- Recruiting
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Oncologia Medica
Candiolo
Pio Manlio Mirko Frascione, MD, piomanliomirko.frascione@inoc.it
Pio Manlio Mirko Frascione, MD
- Recruiting
Istituto Oncologico Veneto, U.O.C. Oncoematologia
Castelfranco Veneto
Nilla Maschio, MD, nilla.maschio@iov.veneto.it
Nilla Maschio, MD
- Recruiting
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, UOC Ematologia
Catania
Annalisa Chiarenza, MD, annalisa.chiarenza@gmail.com
Annalisa Chiarenza, MD
- Recruiting
Azienda Ospedaliera Santa Croce E Carle, S.C. di Ematologia
Cuneo
Elia Boccellato, MD, boccellato.e@ospedale.cuneo.it
Elia Boccellato, MD
- Recruiting
Careggi University Hospital, SOD Ematologia
Florence
Luca Nassi, MD, nassil@aou-careggi.toscana.it
Luca Nassi, MD
- Not yet recruiting
Ssd Ematologia ASLTO4, S.S.D. Ematologia
Ivrea
Chiara Ciochetto, MD, cciochetto@aslto4.piemonte.it
Chiara Ciochetto, MD
- Recruiting
Ospedale Santa Maria Goretti, SOD Ematologia
Latina
Natalia Cenfra, MD, nataliacenfra81@gmail.com
Natalia Cenfra, MD
- Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Oncoematologia
Meldola
Francesco Malaspina, MD, francesco.malaspina@irst.emr.it
Francesco Malaspina, MD
- Recruiting
Azienda Ospedali Riuniti Papardo-Piemonte, U.O. Ematologia
Messina
Donato Mannina, MD, donamanni@gmail.com
Donato Mannina, MD
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Milan
Vittorio Ruggero Zilioli, MD, vittorioruggero.zilioli@ospedaleniguarda.it
Vittorio Ruggero Zilioli, MD
- Recruiting
Fondazione IRCCS Istituto Nazionale Dei Tumori, S.C. Ematologia e Trapianto Midollo Osseo Allogenico
Milan
Paolo Corradini, MD, paolo.corradini@unimi.it
Paolo Corradini, MD
- Recruiting
Ospedale San Raffaele S.r.l., Unitа Linfomi - Dipartimento Oncoematologia
Milan
Andrés Ferreri, MD, andres.ferreri@hsr.it
Andrés Ferreri, MD
- Recruiting
Azienda Ospedaliero Universitaria Di Modena, S.C. Ematologia
Modena
Giovanna Leonardi, MD, leonardi.giovanna@policlinico.mo.it
Giovanna Leonardi, MD
- Recruiting
Azienda Ospedaliera S Gerardo Di Monza, Ematologia
Monza
Silvia Bolis, MD, s.bolis@asst-monza.it
Silvia Bolis, MD
- Recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli, U.O.C. di Ematologia e Trapianti di Midollo
Naples
Fabrizio Pane, MD, fabrizio.pane@unina.it
Fabrizio Pane, MD
- Recruiting
Azienda Ospedaliero-Universitaria Maggiore Della Carita, SCDU Ematologia
Novara
Gloria Margiotta, MD, gloria.margiotta@med.uniupo.it
Gloria Margiotta, MD
- Recruiting
Istituto Oncologico Veneto, UOC Oncologia 1
Padova
Dario Marino, MD, dario.marino@iov.veneto.it
Dario Marino, MD
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Oncoematologia
Palermo
Caterina Patti, MD, k.patti@villasofia.it
Caterina Patti, MD
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, U.O.C. Ematologia
Palermo
Salvatrice Mancuso, MD, salvatrice.mancuso@unipa.it
Salvatrice Mancuso, MD
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo, U.O.C. Ematologia I
Pavia
Luca Arcaini, MD, luca.arcaini@unipv.it
Luca Arcaini, MD
- Recruiting
Hospital Santa Maria Della Misericordia, S.C. di Ematologia con TMO
Perugia
Monia Capponi, MD, monia.capponi@ospedale.perugia.it
Monia Capponi, MD
- Recruiting
Azienda Unità Sanitaria Locale Di Piacenza, U.O.Ematologia
Piacenza
Patrizia Bernuzzi, MD, p.bernuzzi@ausl.pc.it
Patrizia Bernuzzi, MD
- Recruiting
Azienda Ospedaliero Universitaria Pisana, U.O. Ematologia
Pisa
Sara Galimberti, MD, sara.galimberti@med.unipi.it
Sara Galimberti, MD
- Recruiting
Azienda Unita Sanitaria Locale Della Romagna, U.O.C. Ematologia
Ravenna
Monica Tani, MD, monica.tani@auslromagna.it
Monica Tani, MD
- Recruiting
Azienda USL IRCCS Di Reggio Emilia, S.C. Ematologia
Reggio Emilia
Stefano Luminari, MD, stefano.luminari@ausl.re.it
Stefano Luminari, MD
- Recruiting
Azienda Unita Sanitaria Locale Della Romagna, U.O. di Ematologia
Rimini
Melania Celli, MD, melania.celli@auslromagna.it
Melania Celli, MD
- Recruiting
ASL Roma 1, UOSD Ematologia
Roma
Tommaso Caravita di Toritto, MD, tommaso.caravita@aslroma1.it
Tommaso Caravita di Toritto, MD
- Recruiting
Azienda Ospealiero Universitaria Policlinico Umberto I, Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma
Ilaria Del Giudice, MD, ilaria.delgiudice@uniroma1.it
Ilaria Del Giudice, MD
- Not yet recruiting
Azienda Ospedaliera S Giovanni Addolorata, UOC Ematologia
Roma
Paola Anticoli Borza, MD, panticoliborza@hsangiovanni.roma.it
Paola Anticoli Borza, MD
- Recruiting
Azienda Ospedaliero-Universitaria Sant Andrea, UOC Ematologia
Roma
Agostino Tafuri, MD, agostino.tafuri@ospedalesantandrea.it
Agostino Tafuri, MD
- Recruiting
Catholic University Of Sacred Heart, UOC Ematologia e Trapianto di cellule staminali emopoietiche
Roma
Stefan Hohaus, MD, stefan.hohaus@Unicatt.it
Stefan Hohaus, MD
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico, UOC di Ematologia e Trapianto di Cellule Staminali
Roma
Ombretta Annibali, MD, o.annibali@policlinicocampus.it
Ombretta Annibali, MD
- Recruiting
I.F.O. Istituti Fisioterapici Ospitalieri, UOSD Ematologia e Trapianto
Roma
Daniela Renzi, MD, daniela.renzi@ifo.it
Daniela Renzi, MD
- Recruiting
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo, Modena (MO), 41049
Sara Bigliardi, MD, s.bigliardi@ausl.mo.it
Sara Bigliardi, MD
- Recruiting
Ospedale Di Sassuolo S.p.A., U.O.S.D. di Oncologia
Sassuolo
Sara Bigliardi, MD, s.bigliardi@ausl.mo.it
Sara Bigliardi, MD
- Recruiting
Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia
Siena
Emanuele Cencini, MD, cencioema@libero.it
Emanuele Cencini, MD
- Recruiting
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario, Medicina Interna
Sondrio
Andrea Maria Soccodato, MD, andresocco@alice.it
Andrea Maria Soccodato, MD
- Not yet recruiting
Azienda Ospedaliera S Maria Di Terni, S.C. Oncoematologia
Terni
Arcangelo Liso, MD, arcangelo.liso@unipg.it
Arcangelo Liso, MD
- Recruiting
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana, S.C di Ematologia
Treviso
Elisabetta Scarpa, MD, elisabetta.scarpa@aulss2.veneto.it
Elisabetta Scarpa, MD
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale, SOC Clinica Ematologica
Udine
Jacopo Oliveri, MD, jacopo.olivieri@asufc.sanita.fvg.it
Jacopo Oliveri, MD
- Recruiting
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi, U.O.C Ematologia
Varese
Marta Coscia, MD, marta.coscia@asst-settelaghi.it
Marta Coscia, MD
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona, U.O.C. Ematologia
Verona
Isacco Ferrarini, MD, isacco.ferrarini@univr.it
Isacco Ferrarini, MD
About this study
Official title: 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
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.
Read the 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
- Conditions
- Follicular Lymphoma
- Being tested
- Radiotherapy, Radiotherapy plus Obinutuzumab
- Keywords
- Lymphoma, Follicular, Immunotherapy, FL, Radiotherapy, Early, Localized, Obinutuzumab, MRD, Minimal residual disease, PET
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Involved-Site Radiation Therapy 24Gy
Radiotherapy plus ObinutuzumabOther
Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses weekly plus addition 4 doses every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | Active comparator | Radiotherapy alone Receives: Radiation: Radiotherapy |
| Experimental Arm | Experimental | Radiotherapy plus Obinutuzumab Receives: Other: Radiotherapy plus Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time between the randomization to first documentation of recurrence, progression or death from any cause at 2 years
Measured: From treatment start up to 33 months (9 months treatment period and 24 months of follow-up)
Secondary outcomes (14)
Complete response rate (CRR)
Complete response (CR) rate according to the international criteria (Cheson 2014)
Measured: From therapy start up to end of treatment (9 months)
Overall response rate (ORR)
ORR will be defined as the proportion of patients who have a partial or complete response at every treatment phase
Measured: From therapy start up to end of treatment (9 months)
Disease Free Survival (DFS)
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
Measured: From post radiotherapy assessment up to 45 months (9 months treatment phase plus 36 months of follow-up)
Event Free Survival (EFS)
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
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Number of patients with Molecular Response at end of treatment
MRD negativity at end of treatment for positive patients at baseline
Measured: From therapy start up to end of treatment (9 months)
Rate of Adverse Events
Incidence and severity of AEs in both arms according to latest CTCAE criteria
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic and predictive impact of presence/abscence of t(14;18) rearrangement measured by FISH
Prognostic and predictive impact on PFS in presence or absence of t(14;18) rearrangement measured by FISH
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic role of Minimal Residual Disease by conventional (BCL2/IGH rearrangement by ddPCR) and ctDNA method
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
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic and predictive value of different threshold of metabolic response expressed as SUVmax, MTV and TLG at baseline (PET-0);
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;
Measured: At baseline (before therapy start)
Prognostic and predictive role of liquid biopsy by DNA sequencing for lymphoma mutations
Prognostic and predictive role of liquid biopsy by DNA sequencing for lymphoma mutations at different time points on PFS and relapse
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic and predictive value of radiological markers assessed by Machine Learning tools (pyRadiomics)
Prognostic and predictive value of radiomic analysis on PFS, assessed on both CT and PET scans by Machine Learning tools (pyRadiomics);
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Correlation of MRD results with the radiomics results and clinical outcomes
Correlation of MRD results with the radiomics results and clinical outcomes
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Comparison between genotype at diagnosis and at relapse assessed by RNA sequencing (CIBERSORTx)
Comparison between genotype at diagnosis and at relapse assessed by RNA sequencing (CIBERSORTx)
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Evaluation of liquid biopsy as a tool to identity specific mutations predictive for clonal evolution of lymphoma
Evaluation of liquid biopsy as a tool to identity specific mutations predictive for clonal evolution of lymphoma
Measured: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start14 Dec 2023
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Pulsoni, MD, Principal investigator, Ospedale Santa Maria Goretti LatinaAndrea Filippi, MD, Principal investigator, Università di Pavia-Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929222
- Sponsor's protocol ID
- FIL_GAZEBO
- Acronym
- FIL_GAZEBO
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No