Trial Title:
Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi
NCT ID:
NCT05929222
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Obinutuzumab
Conditions: Keywords:
Lymphoma
Follicular
Immunotherapy
FL
Radiotherapy
Early
Localized
Obinutuzumab
MRD
Minimal residual disease
PET
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Involved-Site Radiation Therapy 24Gy
Arm group label:
Standard Arm
Intervention type:
Other
Intervention name:
Radiotherapy plus Obinutuzumab
Description:
Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses
weekly plus addition 4 doses every 3 weeks
Arm group label:
Experimental Arm
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
Criteria for eligibility:
Criteria:
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
11. 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
12. Adequate renal function defined as follows:
- Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
13. 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)
14. 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
15. Subject must be able to adhere to the study visit schedule and other protocol
requirements
16. Life expectancy ≥ 3 months
17. 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:
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
11. 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.
12. If female, the patient is pregnant or breast-feeding
13. Patients participating in other clinical studies.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo, SCDU Ematologia
Address:
City:
Alessandria
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Manuela Zanni, MD
Email:
manuela.zanni@ospedale.al.it
Investigator:
Last name:
Manuela Zanni, MD
Email:
Principal Investigator
Facility:
Name:
AORN San Giuseppe Moscati Avellino, U.O.C. Ematologia e Trapianto Emopoietico
Address:
City:
Avellino
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sonya De Lorenzo, MD
Email:
sonya.delorenzo@tin.it
Investigator:
Last name:
Sonya De Lorenzo, MD
Email:
Principal Investigator
Facility:
Name:
Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
Address:
City:
Aviano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Spina, MD
Email:
mspina@cro.it
Investigator:
Last name:
Michele Spina, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Address:
City:
Bari
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Carla Minoia, MD
Email:
c.minoia@oncologico.bari.it
Investigator:
Last name:
Carla Minoia, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale degli Infermi di Biella, SSD Ematologia
Address:
City:
Biella
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annarita Conconi, MD
Email:
annarita.conconi@aslbi.piemonte.it
Investigator:
Last name:
Annarita Conconi, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, U.O. Ematologia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonella Anastasia, MD
Email:
antonella.anastasia@gmail.com
Investigator:
Last name:
Antonella Anastasia, MD
Email:
Principal Investigator
Facility:
Name:
ARNAS G. Brotzu, SC Ematologia e CTMO
Address:
City:
Cagliari
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Roberta Murru, MD
Email:
roberta.murru@aob.it
Investigator:
Last name:
Roberta Murru, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Oncologia Medica
Address:
City:
Candiolo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Francesca Bonello, MD
Email:
francesca.bonello@ircc.it
Investigator:
Last name:
Francesca Bonello, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Oncologico Veneto, U.O.C. Oncoematologia
Address:
City:
Castelfranco Veneto
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Roberto Sartori, MD
Email:
roberto.sartori@iov.veneto.it
Investigator:
Last name:
Roberto Sartori, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, UOC Ematologia
Address:
City:
Catania
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Annalisa Chiarenza, MD
Email:
annalisa.chiarenza@gmail.com
Investigator:
Last name:
Annalisa Chiarenza, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Santa Croce E Carle, S.C. di Ematologia
Address:
City:
Cuneo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessia Castellino, MD
Email:
castellino.ale@ospedale.cuneo.it
Investigator:
Last name:
Alessia Castellino, MD
Email:
Principal Investigator
Facility:
Name:
Careggi University Hospital, SOD Ematologia
Address:
City:
Firenze
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luca Nassi, MD
Email:
nassil@aou-careggi.toscana.it
Investigator:
Last name:
Luca Nassi, MD
Email:
Principal Investigator
Facility:
Name:
Ssd Ematologia ASLTO4, S.S.D. Ematologia
Address:
City:
Ivrea
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Chiara Ciochetto, MD
Email:
cciochetto@aslto4.piemonte.it
Investigator:
Last name:
Chiara Ciochetto, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Santa Maria Goretti, SOD Ematologia
Address:
City:
Latina
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Pulsoni, MD
Email:
alessandro.pulsoni@uniroma1.it
Investigator:
Last name:
Alessandro Pulsoni, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Oncoematologia
Address:
City:
Meldola
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Francesco Malaspina, MD
Email:
francesco.malaspina@irst.emr.it
Investigator:
Last name:
Francesco Malaspina, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedali Riuniti Papardo-Piemonte, U.O. Ematologia
Address:
City:
Messina
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Donato Mannina, MD
Email:
donamanni@gmail.com
Investigator:
Last name:
Donato Mannina, MD
Email:
Principal Investigator
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Vittorio Ruggero Zilioli, MD
Email:
vittorioruggero.zilioli@ospedaleniguarda.it
Investigator:
Last name:
Vittorio Ruggero Zilioli, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale Dei Tumori, S.C. Ematologia e Trapianto Midollo Osseo Allogenico
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Paolo Corradini, MD
Email:
paolo.corradini@unimi.it
Investigator:
Last name:
Paolo Corradini, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale San Raffaele S.r.l., Unitа Linfomi - Dipartimento Oncoematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Andrés Ferreri, MD
Email:
andres.ferreri@hsr.it
Investigator:
Last name:
Andrés Ferreri, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero Universitaria Di Modena, S.C. Ematologia
Address:
City:
Modena
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giovanna Leonardi, MD
Email:
leonardi.giovanna@policlinico.mo.it
Investigator:
Last name:
Giovanna Leonardi, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera S Gerardo Di Monza, Ematologia
Address:
City:
Monza
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Silvia Bolis, MD
Email:
s.bolis@asst-monza.it
Investigator:
Last name:
Silvia Bolis, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Federico II Di Napoli, U.O.C. di Ematologia e Trapianti di Midollo
Address:
City:
Napoli
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Fabrizio Pane, MD
Email:
fabrizio.pane@unina.it
Investigator:
Last name:
Fabrizio Pane, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria Maggiore Della Carita, SCDU Ematologia
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gloria Margiotta, MD
Email:
gloria.margiotta@med.uniupo.it
Investigator:
Last name:
Gloria Margiotta, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Oncologico Veneto, UOC Oncologia 1
Address:
City:
Padova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Dario Marino, MD
Email:
dario.marino@iov.veneto.it
Investigator:
Last name:
Dario Marino, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Oncoematologia
Address:
City:
Palermo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Caterina Patti, MD
Email:
k.patti@villasofia.it
Investigator:
Last name:
Caterina Patti, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, U.O.C. Ematologia
Address:
City:
Palermo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Salvatrice Mancuso, MD
Email:
salvatrice.mancuso@unipa.it
Investigator:
Last name:
Salvatrice Mancuso, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo, U.O.C. Ematologia I
Address:
City:
Pavia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luca Arcaini, MD
Email:
luca.arcaini@unipv.it
Investigator:
Last name:
Luca Arcaini, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Santa Maria Della Misericordia, S.C. di Ematologia con TMO
Address:
City:
Perugia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Flavio Falcinelli, MD
Email:
flavio.falcinelli@ospedale.perugia.it
Investigator:
Last name:
Flavio Falcinelli, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Unità Sanitaria Locale Di Piacenza, U.O.Ematologia
Address:
City:
Piacenza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Patrizia Bernuzzi, MD
Email:
p.bernuzzi@ausl.pc.it
Investigator:
Last name:
Patrizia Bernuzzi, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero Universitaria Pisana, U.O. Ematologia
Address:
City:
Pisa
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sara Galimberti, MD
Email:
sara.galimberti@med.unipi.it
Investigator:
Last name:
Sara Galimberti, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Unita Sanitaria Locale Della Romagna, U.O.C. Ematologia
Address:
City:
Ravenna
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Monica Tani, MD
Email:
monica.tani@auslromagna.it
Investigator:
Last name:
Monica Tani, MD
Email:
Principal Investigator
Facility:
Name:
Azienda USL IRCCS Di Reggio Emilia, S.C. Ematologia
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefano Luminari, MD
Email:
stefano.luminari@ausl.re.it
Investigator:
Last name:
Stefano Luminari, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Unita Sanitaria Locale Della Romagna, U.O. di Ematologia
Address:
City:
Rimini
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Melania Celli, MD
Email:
melania.celli@auslromagna.it
Investigator:
Last name:
Melania Celli, MD
Email:
Principal Investigator
Facility:
Name:
ASL Roma 1, UOSD Ematologia
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Tommaso Caravita di Toritto, MD
Email:
tommaso.caravita@aslroma1.it
Investigator:
Last name:
Tommaso Caravita di Toritto, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospealiero Universitaria Policlinico Umberto I, Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ilaria Del Giudice, MD
Email:
ilaria.delgiudice@uniroma1.it
Investigator:
Last name:
Ilaria Del Giudice, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera S Giovanni Addolorata, UOC Ematologia
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Paola Anticoli Borza, MD
Email:
panticoliborza@hsangiovanni.roma.it
Investigator:
Last name:
Paola Anticoli Borza, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria Sant Andrea, UOC Ematologia
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Agostino Tafuri, MD
Email:
agostino.tafuri@ospedalesantandrea.it
Investigator:
Last name:
Agostino Tafuri, MD
Email:
Principal Investigator
Facility:
Name:
Catholic University Of Sacred Heart, UOC Ematologia e Trapianto di cellule staminali emopoietiche
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Stefan Hohaus, MD
Email:
stefan.hohaus@Unicatt.it
Investigator:
Last name:
Stefan Hohaus, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione Policlinico Universitario Campus Bio-Medico, UOC di Ematologia e Trapianto di Cellule Staminali
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ombretta Annibali, MD
Email:
o.annibali@policlinicocampus.it
Investigator:
Last name:
Ombretta Annibali, MD
Email:
Principal Investigator
Facility:
Name:
I.F.O. Istituti Fisioterapici Ospitalieri, UOSD Ematologia e Trapianto
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Daniela Renzi, MD
Email:
daniela.renzi@ifo.it
Investigator:
Last name:
Daniela Renzi, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Di Sassuolo S.p.A., U.O.S.D. di Oncologia
Address:
City:
Sassuolo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sara Bigliardi, MD
Email:
s.bigliardi@ausl.mo.it
Investigator:
Last name:
Sara Bigliardi, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia
Address:
City:
Siena
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Emanuele Cencini, MD
Email:
cencioema@libero.it
Investigator:
Last name:
Emanuele Cencini, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario, Medicina Interna
Address:
City:
Sondrio
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Andrea Maria Soccodato, MD
Email:
andresocco@alice.it
Investigator:
Last name:
Andrea Maria Soccodato, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera S Maria Di Terni, S.C. Oncoematologia
Address:
City:
Terni
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Anna Maria Liberati, MD
Email:
marina.liberati@unipg.it
Investigator:
Last name:
Anna Maria Liberati, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana, S.C di Ematologia
Address:
City:
Treviso
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elisabetta Scarpa, MD
Email:
elisabetta.scarpa@aulss2.veneto.it
Investigator:
Last name:
Elisabetta Scarpa, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Universitaria Friuli Centrale, SOC Clinica Ematologica
Address:
City:
Udine
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Jacopo Oliveri, MD
Email:
jacopo.olivieri@asufc.sanita.fvg.it
Investigator:
Last name:
Jacopo Oliveri, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi, U.O.C Ematologia
Address:
City:
Varese
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Merli, MD
Email:
michele.merli@asst-settelaghi.it
Investigator:
Last name:
Michele Merli, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata Verona, U.O.C. Ematologia
Address:
City:
Verona
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Isacco Ferrarini, MD
Email:
isacco.ferrarini@univr.it
Investigator:
Last name:
Isacco Ferrarini, MD
Email:
Principal Investigator
Start date:
December 14, 2023
Completion date:
April 2031
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05929222
