- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05929222
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi (FIL_GAZEBO)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Uffici Studi FIL
- Phone Number: +390131033153
- Email: startup@filinf.it
Study Contact Backup
- Name: Uffici Studi FIL
- Phone Number: +390599769913
- Email: gestionestudi@filinf.it
Study Locations
-
-
-
Alessandria, Italy
- Recruiting
- Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo, SCDU Ematologia
-
Contact:
- Manuela Zanni, MD
- Email: manuela.zanni@ospedale.al.it
-
Principal Investigator:
- Manuela Zanni, MD
-
Avellino, Italy
- Recruiting
- AORN San Giuseppe Moscati Avellino, U.O.C. Ematologia e Trapianto Emopoietico
-
Contact:
- Sonya De Lorenzo, MD
- Email: sonya.delorenzo@tin.it
-
Principal Investigator:
- Sonya De Lorenzo, MD
-
Aviano, Italy
- Recruiting
- Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
-
Contact:
- Michele Spina, MD
- Email: mspina@cro.it
-
Principal Investigator:
- Michele Spina, MD
-
Bari, Italy
- Recruiting
- Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
-
Contact:
- Carla Minoia, MD
- Email: c.minoia@oncologico.bari.it
-
Principal Investigator:
- Carla Minoia, MD
-
Biella, Italy
- Recruiting
- Ospedale degli Infermi di Biella, SSD Ematologia
-
Contact:
- Annarita Conconi, MD
- Email: annarita.conconi@aslbi.piemonte.it
-
Principal Investigator:
- Annarita Conconi, MD
-
Brescia, Italy
- Recruiting
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, U.O. Ematologia
-
Principal Investigator:
- Antonella Anastasia, MD
-
Contact:
- Antonella Anastasia, MD
- Email: antonella.anastasia@gmail.com
-
Cagliari, Italy
- Not yet recruiting
- ARNAS G. Brotzu, SC Ematologia e CTMO
-
Contact:
- Roberta Murru, MD
- Email: roberta.murru@aob.it
-
Principal Investigator:
- Roberta Murru, MD
-
Candiolo, Italy
- Recruiting
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Oncologia Medica
-
Contact:
- Francesca Bonello, MD
- Email: francesca.bonello@ircc.it
-
Principal Investigator:
- Francesca Bonello, MD
-
Castelfranco Veneto, Italy
- Recruiting
- Istituto Oncologico Veneto, U.O.C. Oncoematologia
-
Contact:
- Nilla Maschio, MD
- Email: nilla.maschio@iov.veneto.it
-
Principal Investigator:
- Nilla Maschio, MD
-
Catania, Italy
- Not yet recruiting
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, UOC Ematologia
-
Contact:
- Annalisa Chiarenza, MD
- Email: annalisa.chiarenza@gmail.com
-
Principal Investigator:
- Annalisa Chiarenza, MD
-
Cuneo, Italy
- Recruiting
- Azienda Ospedaliera Santa Croce E Carle, S.C. di Ematologia
-
Contact:
- Elia Boccellato, MD
- Email: boccellato.e@ospedale.cuneo.it
-
Principal Investigator:
- Elia Boccellato, MD
-
Florence, Italy
- Recruiting
- Careggi University Hospital, SOD Ematologia
-
Principal Investigator:
- Luca Nassi, MD
-
Contact:
- Luca Nassi, MD
- Email: nassil@aou-careggi.toscana.it
-
Ivrea, Italy
- Not yet recruiting
- Ssd Ematologia ASLTO4, S.S.D. Ematologia
-
Contact:
- Chiara Ciochetto, MD
- Email: cciochetto@aslto4.piemonte.it
-
Principal Investigator:
- Chiara Ciochetto, MD
-
Latina, Italy
- Recruiting
- Ospedale Santa Maria Goretti, SOD Ematologia
-
Contact:
- Alessandro Pulsoni, MD
- Email: alessandro.pulsoni@uniroma1.it
-
Principal Investigator:
- Alessandro Pulsoni, MD
-
Meldola, Italy
- Recruiting
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Oncoematologia
-
Contact:
- Francesco Malaspina, MD
- Email: francesco.malaspina@irst.emr.it
-
Principal Investigator:
- Francesco Malaspina, MD
-
Messina, Italy
- Recruiting
- Azienda Ospedali Riuniti Papardo-Piemonte, U.O. Ematologia
-
Contact:
- Donato Mannina, MD
- Email: donamanni@gmail.com
-
Principal Investigator:
- Donato Mannina, MD
-
Milan, Italy
- Recruiting
- ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
-
Contact:
- Vittorio Ruggero Zilioli, MD
- Email: vittorioruggero.zilioli@ospedaleniguarda.it
-
Principal Investigator:
- Vittorio Ruggero Zilioli, MD
-
Milan, Italy
- Recruiting
- Fondazione IRCCS Istituto Nazionale Dei Tumori, S.C. Ematologia e Trapianto Midollo Osseo Allogenico
-
Principal Investigator:
- Paolo Corradini, MD
-
Contact:
- Paolo Corradini, MD
- Email: paolo.corradini@unimi.it
-
Milan, Italy
- Recruiting
- Ospedale San Raffaele S.r.l., Unitа Linfomi - Dipartimento Oncoematologia
-
Contact:
- Andrés Ferreri, MD
- Email: andres.ferreri@hsr.it
-
Principal Investigator:
- Andrés Ferreri, MD
-
Modena, Italy
- Recruiting
- Azienda Ospedaliero Universitaria Di Modena, S.C. Ematologia
-
Contact:
- Giovanna Leonardi, MD
- Email: leonardi.giovanna@policlinico.mo.it
-
Principal Investigator:
- Giovanna Leonardi, MD
-
Monza, Italy
- Recruiting
- Azienda Ospedaliera S Gerardo Di Monza, Ematologia
-
Principal Investigator:
- Silvia Bolis, MD
-
Contact:
- Silvia Bolis, MD
- Email: s.bolis@asst-monza.it
-
Naples, Italy
- Recruiting
- Azienda Ospedaliera Universitaria Federico II Di Napoli, U.O.C. di Ematologia e Trapianti di Midollo
-
Contact:
- Fabrizio Pane, MD
- Email: fabrizio.pane@unina.it
-
Principal Investigator:
- Fabrizio Pane, MD
-
Novara, Italy
- Recruiting
- Azienda Ospedaliero-Universitaria Maggiore Della Carita, SCDU Ematologia
-
Contact:
- Gloria Margiotta, MD
- Email: gloria.margiotta@med.uniupo.it
-
Principal Investigator:
- Gloria Margiotta, MD
-
Padova, Italy
- Recruiting
- Istituto Oncologico Veneto, UOC Oncologia 1
-
Contact:
- Dario Marino, MD
- Email: dario.marino@iov.veneto.it
-
Principal Investigator:
- Dario Marino, MD
-
Palermo, Italy
- Not yet recruiting
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, U.O.C. Ematologia
-
Contact:
- Salvatrice Mancuso, MD
- Email: salvatrice.mancuso@unipa.it
-
Principal Investigator:
- Salvatrice Mancuso, MD
-
Palermo, Italy
- Recruiting
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Oncoematologia
-
Contact:
- Caterina Patti, MD
- Email: k.patti@villasofia.it
-
Principal Investigator:
- Caterina Patti, MD
-
Pavia, Italy
- Not yet recruiting
- Fondazione IRCCS Policlinico San Matteo, U.O.C. Ematologia I
-
Contact:
- Luca Arcaini, MD
- Email: luca.arcaini@unipv.it
-
Principal Investigator:
- Luca Arcaini, MD
-
Perugia, Italy
- Recruiting
- Hospital Santa Maria Della Misericordia, S.C. di Ematologia con TMO
-
Contact:
- Monia Capponi, MD
- Email: monia.capponi@ospedale.perugia.it
-
Principal Investigator:
- Monia Capponi, MD
-
Piacenza, Italy
- Recruiting
- Azienda Unità Sanitaria Locale Di Piacenza, U.O.Ematologia
-
Contact:
- Patrizia Bernuzzi, MD
- Email: p.bernuzzi@ausl.pc.it
-
Principal Investigator:
- Patrizia Bernuzzi, MD
-
Pisa, Italy
- Recruiting
- Azienda Ospedaliero Universitaria Pisana, U.O. Ematologia
-
Contact:
- Sara Galimberti, MD
- Email: sara.galimberti@med.unipi.it
-
Principal Investigator:
- Sara Galimberti, MD
-
Ravenna, Italy
- Recruiting
- Azienda Unita Sanitaria Locale Della Romagna, U.O.C. Ematologia
-
Contact:
- Monica Tani, MD
- Email: monica.tani@auslromagna.it
-
Principal Investigator:
- Monica Tani, MD
-
Reggio Emilia, Italy
- Recruiting
- Azienda USL IRCCS Di Reggio Emilia, S.C. Ematologia
-
Contact:
- Stefano Luminari, MD
- Email: stefano.luminari@ausl.re.it
-
Principal Investigator:
- Stefano Luminari, MD
-
Rimini, Italy
- Recruiting
- Azienda Unita Sanitaria Locale Della Romagna, U.O. di Ematologia
-
Contact:
- Melania Celli, MD
- Email: melania.celli@auslromagna.it
-
Principal Investigator:
- Melania Celli, MD
-
Roma, Italy
- Not yet recruiting
- Azienda Ospedaliera S Giovanni Addolorata, UOC Ematologia
-
Contact:
- Paola Anticoli Borza, MD
- Email: panticoliborza@hsangiovanni.roma.it
-
Principal Investigator:
- Paola Anticoli Borza, MD
-
Roma, Italy
- Recruiting
- ASL Roma 1, UOSD Ematologia
-
Contact:
- Tommaso Caravita di Toritto, MD
- Email: tommaso.caravita@aslroma1.it
-
Principal Investigator:
- Tommaso Caravita di Toritto, MD
-
Roma, Italy
- Recruiting
- Azienda Ospealiero Universitaria Policlinico Umberto I, Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
-
Contact:
- Ilaria Del Giudice, MD
- Email: ilaria.delgiudice@uniroma1.it
-
Principal Investigator:
- Ilaria Del Giudice, MD
-
Roma, Italy
- Recruiting
- Azienda Ospedaliero-Universitaria Sant Andrea, UOC Ematologia
-
Principal Investigator:
- Agostino Tafuri, MD
-
Contact:
- Agostino Tafuri, MD
- Email: agostino.tafuri@ospedalesantandrea.it
-
Roma, Italy
- Recruiting
- Fondazione Policlinico Universitario Campus Bio-Medico, UOC di Ematologia e Trapianto di Cellule Staminali
-
Principal Investigator:
- Ombretta Annibali, MD
-
Contact:
- Ombretta Annibali, MD
- Email: o.annibali@policlinicocampus.it
-
Roma, Italy
- Recruiting
- I.F.O. Istituti Fisioterapici Ospitalieri, UOSD Ematologia e Trapianto
-
Contact:
- Daniela Renzi, MD
- Email: daniela.renzi@ifo.it
-
Principal Investigator:
- Daniela Renzi, MD
-
Roma, Italy
- Recruiting
- Catholic University Of Sacred Heart, UOC Ematologia e Trapianto di cellule staminali emopoietiche
-
Contact:
- Stefan Hohaus, MD
- Email: stefan.hohaus@Unicatt.it
-
Principal Investigator:
- Stefan Hohaus, MD
-
Sassuolo, Italy
- Recruiting
- Ospedale Di Sassuolo S.p.A., U.O.S.D. di Oncologia
-
Contact:
- Sara Bigliardi, MD
- Email: s.bigliardi@ausl.mo.it
-
Principal Investigator:
- Sara Bigliardi, MD
-
Siena, Italy
- Recruiting
- Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia
-
Contact:
- Emanuele Cencini, MD
- Email: cencioema@libero.it
-
Principal Investigator:
- Emanuele Cencini, MD
-
Sondrio, Italy
- Recruiting
- Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario, Medicina Interna
-
Contact:
- Andrea Maria Soccodato, MD
- Email: andresocco@alice.it
-
Principal Investigator:
- Andrea Maria Soccodato, MD
-
Terni, Italy
- Not yet recruiting
- Azienda Ospedaliera S Maria Di Terni, S.C. Oncoematologia
-
Contact:
- Anna Maria Liberati, MD
- Email: marina.liberati@unipg.it
-
Principal Investigator:
- Anna Maria Liberati, MD
-
Treviso, Italy
- Recruiting
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana, S.C di Ematologia
-
Contact:
- Elisabetta Scarpa, MD
- Email: elisabetta.scarpa@aulss2.veneto.it
-
Principal Investigator:
- Elisabetta Scarpa, MD
-
Udine, Italy
- Recruiting
- Azienda Sanitaria Universitaria Friuli Centrale, SOC Clinica Ematologica
-
Contact:
- Jacopo Oliveri, MD
- Email: jacopo.olivieri@asufc.sanita.fvg.it
-
Principal Investigator:
- Jacopo Oliveri, MD
-
Varese, Italy
- Recruiting
- Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi, U.O.C Ematologia
-
Contact:
- Marta Coscia, MD
- Email: marta.coscia@asst-settelaghi.it
-
Principal Investigator:
- Marta Coscia, MD
-
Verona, Italy
- Recruiting
- Azienda Ospedaliera Universitaria Integrata Verona, U.O.C. Ematologia
-
Contact:
- Isacco Ferrarini, MD
- Email: isacco.ferrarini@univr.it
-
Principal Investigator:
- Isacco Ferrarini, MD
-
-
Modena (MO)
-
Sassuolo, Modena (MO), Italy, 41049
- Recruiting
- Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
-
Contact:
- Sara Bigliardi, MD
- Email: s.bigliardi@ausl.mo.it
-
Principal Investigator:
- Sara Bigliardi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Arm
Radiotherapy alone
|
Involved-Site Radiation Therapy 24Gy
|
|
Experimental: Experimental Arm
Radiotherapy plus Obinutuzumab
|
Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses weekly plus addition 4 doses every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS)
Time Frame: From treatment start up to 33 months (9 months treatment period and 24 months of follow-up)
|
Time between the randomization to first documentation of recurrence, progression or death from any cause at 2 years
|
From treatment start up to 33 months (9 months treatment period and 24 months of follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete response rate (CRR)
Time Frame: From therapy start up to end of treatment (9 months)
|
Complete response (CR) rate according to the international criteria (Cheson 2014)
|
From therapy start up to end of treatment (9 months)
|
|
Overall response rate (ORR)
Time Frame: From therapy start up to end of treatment (9 months)
|
ORR will be defined as the proportion of patients who have a partial or complete response at every treatment phase
|
From therapy start up to end of treatment (9 months)
|
|
Disease Free Survival (DFS)
Time Frame: From post radiotherapy assessment up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
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
|
From post radiotherapy assessment up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
|
Event Free Survival (EFS)
Time Frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
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
|
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
Time Frame: From therapy start up to end of treatment (9 months)
|
MRD negativity at end of treatment for positive patients at baseline
|
From therapy start up to end of treatment (9 months)
|
|
Rate of Adverse Events
Time Frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
Incidence and severity of AEs in both arms according to latest CTCAE criteria
|
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
Time Frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
Prognostic and predictive impact on PFS in presence or absence of t(14;18) rearrangement measured by FISH
|
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
Time Frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
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
|
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);
Time Frame: At baseline (before therapy start)
|
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;
|
At baseline (before therapy start)
|
|
Prognostic and predictive role of liquid biopsy by DNA sequencing for lymphoma mutations
Time Frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
Prognostic and predictive role of liquid biopsy by DNA sequencing for lymphoma mutations at different time points on PFS and relapse
|
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)
Time Frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
|
Prognostic and predictive value of radiomic analysis on PFS, assessed on both CT and PET scans by Machine Learning tools (pyRadiomics);
|
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
Time Frame: 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
|
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)
Time Frame: 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)
|
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
Time Frame: 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
|
From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alessandro Pulsoni, MD, Ospedale Santa Maria Goretti Latina
- Principal Investigator: Andrea Filippi, MD, Università di Pavia-Fondazione IRCCS Policlinico San Matteo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplastic Processes
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Neoplasm, Residual
- Lymphoma
- Lymphoma, Follicular
- Therapeutics
- Radiotherapy
- obinutuzumab
Other Study ID Numbers
- FIL_GAZEBO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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