Clinical trial • Phase III • Oncology
N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3-NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-YL}-7-AZASPIRO[3.5]NONAN-7-YL)-2-[(1H-PYRROLO[2,3-B]PYRIDIN-5-YL)OXY]BENZAMIDE for Previously Untreated Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia
Phase III trial of N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3-NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-Y…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Previously Untreated Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 27-10-2023
- First CTIS Authorization Date
- 04-03-2024
Trial design
Randomised, open-label, venetoclax (venclyxto 100 mg film-coated tablets) plus obinutuzumab (gazyvaro 1,000 mg concentrate for solution for infusion). doses/schedules not specified in ctis record.-controlled Phase III trial in Spain, Sweden, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Venetoclax (Venclyxto 100 mg film-coated tablets) plus Obinutuzumab (Gazyvaro 1,000 mg concentrate for solution for infusion). Doses/schedules not specified in CTIS record.
- Target Sample Size
- 466
Eligibility
Recruits 466 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be aged ≥18 years; informed consent is obtained from participants (adult consent). No assent for minors is applicable because minors are excluded..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be aged ≥18 years; informed consent is obtained from participants (adult consent). No assent for minors is applicable because minors are excluded.
Inclusion criteria
- {"criterion_text":"- Patients aged ≥ 18 years will have a confirmed diagnosis of CLL, based on Hallek et al 2018, requiring treatment as defined by ≥ 1 of the following: progressive bone marrow failure; massive, progressive, or symptomatic splenomegaly; massive, progressive, or symptomatic lymphadenopathy; progressive lymphocytosis with rapid doubling time; symptomatic or functional extranodal involvement; and/or constitutional symptoms."}
Exclusion criteria
- {"criterion_text":"- Eligible patients must have ≥ 1 measurable lymph node based on computed tomography/magnetic resonance imaging and no prior systemic treatment for CLL; no history of or known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation at time of consideration for study; no ongoing clinically significant cardiovascular disease; and no active infection including hepatitis B or C virus or HIV. Patients who require treatment with warfarin or other vitamin K antagonists will be excluded."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Cohort 1: PFS, defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by IRC.","definition_or_measurement_approach":"Time from enrollment to first confirmed disease progression or death; determined by independent review committee (IRC)."}
- {"endpoint_text":"- Intermediate (Cohort 1): Undetectable minimal residual disease at < 10^-4 sensitivity (uMRD4) rate at the first Post-treatment Follow-up (PTFU1) Visit based on next-generation sequencing (NGS [clonoSEQ]).","definition_or_measurement_approach":"uMRD4 measured at first post-treatment follow-up (PTFU1) using next-generation sequencing (NGS, clonoSEQ) with sensitivity <10^-4."}
Secondary endpoints
- {"endpoint_text":"- Cohort 1: Overall complete response rate (CRR) defined as the proportion of patients that achieved best response of CR/CRi, determined by IRC.","definition_or_measurement_approach":"Proportion of patients achieving best response of CR or CRi as determined by independent review committee (IRC)."}
- {"endpoint_text":"- Cohort 1: OS, defined as time from the date of enrollment to the date of death because of any cause","definition_or_measurement_approach":"Time from enrollment to death from any cause (overall survival, OS)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 466
- Recruitment Window Months
- 99
- Consent Approach
- Informed consent obtained from participants (adults ≥18). Subject information and ICF documents provided; ICF materials available in multiple languages (documents list includes EN, DE, FR, IT, NL, PL, CZ, ES, SE). Consent is provided by the participant; no assent for minors because study excludes participants <18.
Geography
- Total Number Of Sites
- 55
- Total Number Of Participants
- 206
Spain
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 781
- Number Of Sites
- 8
- Number Of Participants
- 22
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Contact Person Name
- Eva González Barca
- Contact Person Email
- e.gonzalez@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology
- Contact Person Name
- Javier López Jiménez
- Contact Person Email
- jljimenez@salud.madrid.org
- Site Name
- Hospital Universitario La Paz
- Department Name
- Hematology
- Contact Person Name
- Patricia Baltasar Tello
- Contact Person Email
- XXXXX@XXXX.XX
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Contact Person Name
- Javier de La Serna
- Contact Person Email
- javier.serna@salud.madrid.org
- Site Name
- Hospital Universitario Nuestra Senora De Candelaria
- Department Name
- Hematology and Hemotherapy
- Contact Person Name
- Carmen Marrero Santos
- Contact Person Email
- XXXXX@XXXX.XX
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Hematology
- Contact Person Name
- Alexia Suárez Cabrera
- Contact Person Email
- asuacab@gobiernodecanarias.org
- Site Name
- MD Anderson Cancer Center
- Department Name
- Hematology
- Contact Person Name
- Adolfo de la Fuente
- Contact Person Email
- afuente@mdanderson.es
- Site Name
- Hospital Universitario De Burgos
- Department Name
- Hematology and Hemotherapy
- Contact Person Name
- Francisco Javier Díaz Gálvez
- Contact Person Email
- fcdiaz@saludcastillayleon.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 08-05-2024
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 701
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Cancerstudieenheten
- Contact Person Name
- Anders Österborg
- Contact Person Email
- xxxx.xxx@regionstockholm.se
Poland
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 789
- Number Of Sites
- 6
- Number Of Participants
- 30
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
- Contact Person Name
- Tomasz Wrobel
- Contact Person Email
- XX@XX
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Klinika Hematologii, Poradnia Hematologiczna
- Contact Person Name
- Ewa Lech-Maranda
- Contact Person Email
- emaranda@ihit.waw.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Contact Person Name
- Krzysztof Giannopoulos
- Contact Person Email
- XX@XX
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddzial Hematologii i Transplantacji Szpiku, Poradnia Hematologiczna
- Contact Person Name
- Lidia Gil
- Contact Person Email
- lidia.gil@skpp.edu.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii Ogolnej i Chorob Wewnetrznych
- Contact Person Name
- Tadeusz Robak
- Contact Person Email
- robaktad@csk.umed.lodz.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- CSK Klinika Hematologii, Transplantologii i Chorob Wewnetrznych, Poradnia Hematologiczna
- Contact Person Name
- Krzysztof Jamroziak
- Contact Person Email
- k.jamroziak@wum.edu.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-02-2024
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 790
- Number Of Sites
- 6
- Number Of Participants
- 30
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. interní klinika - klinika hematologie 1.LF a VFN
- Contact Person Name
- Martin Spacek
- Contact Person Email
- xxxx@vfn.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- 4.interní hematologická klinika
- Contact Person Name
- Martin Simkovic
- Contact Person Email
- xxx@fnhk.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní hematologická a onkologická klinika
- Contact Person Name
- Michael Doubek
- Contact Person Email
- xxxxx@fnbrno.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Contact Person Name
- Jana Mihalyova
- Contact Person Email
- xxx@fno.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Hemato-onkologická klinika
- Contact Person Name
- Zuzana Kubova
- Contact Person Email
- xxxx@fnol.cz
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- Hematologicko-onkologické oddělení FN Plzeň
- Contact Person Name
- Daniel Lysak
- Contact Person Email
- xxxx@fnplzen.cz
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 786
- Number Of Sites
- 8
- Number Of Participants
- 26
Sites
- Site Name
- Amsterdam UMC
- Department Name
- Hematology
- Contact Person Name
- Arnon Kater
- Contact Person Email
- ctis@amsterdamumc.nl
- Site Name
- Stichting Martini Ziekenhuis
- Department Name
- Wetenschappelijk instituut
- Contact Person Name
- John Schreurs
- Contact Person Email
- j.schreurs@mzh.nl
- Site Name
- Haga Hospital
- Department Name
- Hematology
- Contact Person Name
- Sabina Kersting
- Contact Person Email
- s.kersting@hagaziekenhuis.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Hematology
- Contact Person Name
- Hein Visser
- Contact Person Email
- h.visser@nwz.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Hematology
- Contact Person Name
- Mark-David Levin
- Contact Person Email
- m-d.levin@asz.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- Hematology
- Contact Person Name
- Henk-Jan Boiten
- Contact Person Email
- h.boiten@franciscus.nl
- Site Name
- Ikazia Ziekenhuis
- Department Name
- Hematology
- Contact Person Name
- Fransien De Boer
- Contact Person Email
- fr.de.boer@ikazia.nl
- Site Name
- Meander Medisch Centrum
- Department Name
- Hematology
- Contact Person Name
- Josien Regelink
- Contact Person Email
- JC.regelink@meandermc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 16-02-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 787
- Number Of Sites
- 7
- Number Of Participants
- 22
Sites
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Hematology
- Contact Person Name
- Annamaria Frustaci
- Contact Person Email
- annamaria.frustaci@ospedaleniguarda.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Medicine and Surgery
- Contact Person Name
- Paolo Sportoletti
- Contact Person Email
- paolo.sportoletti@unipg.it
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- oncological and hematological diseases
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Azienda Ospedale-Universita Padova
- Department Name
- Hematology
- Contact Person Name
- Andrea Visentin
- Contact Person Email
- andrea.visentin@aopd.veneto.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- Division of Hematology
- Contact Person Name
- Gianluca Gaidano
- Contact Person Email
- gianluca.gaidano@med.uniupo.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- Hematology Oncology
- Contact Person Name
- Antonio Cuneo
- Contact Person Email
- cut@unife.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Oncohematology Deparment
- Contact Person Name
- Enrico Derenzini
- Contact Person Email
- enrico.derenzini@ieo.it
Germany
- Earliest CTIS Part Ii Submission Date
- 07-05-2024
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 703
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Centrum für Hämatologie und Onkologie Bethanien
- Contact Person Name
- Christian Johannes Schmitt
- Contact Person Email
- schmitt@onkologie-bethanien.com
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Hämatologie und Onkologie
- Contact Person Name
- Niklas Gebauer
- Contact Person Email
- xxx@uksh.de
- Site Name
- IQVIA
- Contact Person Name
- Jan-Piet Habbel
- Contact Person Email
- xxx@praxis-am-volkspark-berlin.de
France
- Earliest CTIS Part Ii Submission Date
- 05-02-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 798
- Number Of Sites
- 13
- Number Of Participants
- 39
Sites
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Thérapie Cellulaire et Hématologie
- Contact Person Name
- Romain GUIEZE
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hématologie et Thérapie Cellulaire
- Contact Person Name
- Caroline DARTIGEAS
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- L'Hopital Prive Du Confluent
- Department Name
- Hématologie
- Contact Person Name
- Katell LE DU
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hématologie Clinique
- Contact Person Name
- Anne LOK
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hématologie Clinique
- Contact Person Name
- Damien ROOS-WEIL
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- CHRU De Nancy
- Department Name
- Hématologie Médecine Interne
- Contact Person Name
- Pierre FEUGIER
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hématologie
- Contact Person Name
- Caroline DARTIGEAS
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Contact Person Name
- Anne-Sophie MICHALLET
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Hématologie
- Contact Person Name
- Kamel LARIBI
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Institut Bergonie
- Department Name
- Hématologie
- Contact Person Name
- Fontanet BIJOU
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Maladies du Sang
- Contact Person Name
- Doriane CAVALIERI
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Henri Becquerel
- Department Name
- Hématologie
- Contact Person Name
- Stephane LEPRETRE
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Clinique Louis Pasteur
- Department Name
- Oncologie
- Contact Person Name
- Serge BOLOGNA
- Contact Person Email
- xxxxxx@xxxxxxx.fr
Austria
- Earliest CTIS Part Ii Submission Date
- 09-02-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 794
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- University Clinic for Internal Medicine III
- Contact Person Name
- Alexander Egle
- Contact Person Email
- a.egle@salk.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Internal Medicine V, Hematology and Oncology
- Contact Person Name
- Jan-Paul Bohn
- Contact Person Email
- jan-paul.bohn@i-med.ac.at
- Site Name
- Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
- Department Name
- 3rd Medical Department for Hematology and Oncology
- Contact Person Name
- Thomas Nösslinger
- Contact Person Email
- thomas.noesslinger@oegk.at
Sponsor
Primary sponsor
- Full Name
- BeOne Medicines AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Medidata Solutions International Limited
- Responsibilities
- E-data capture
- Name
- PPD (UK) Limited
- Responsibilities
- Safety reporting
- Name
- Iqvia Biotech LLC
- Responsibilities
- Administrative
- Name
- Bioclinica Shanghai Co. Ltd.
- Responsibilities
- Medical Image Analysis/Review
- Name
- Scout Clinical
- Responsibilities
- Patient travel reimbursement
Third parties
- {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Clinical Supply Vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"E-data capture","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"code 14","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ledger Run Inc.","duties_or_roles":"Administrative","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Administrative","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Bioclinica Shanghai Co. Ltd.","duties_or_roles":"Medical Image Analysis/Review","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"Safety reporting","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MLL Dx GmbH","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Clinical Supply Vendor","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Zuellig Pharma Specialty Solutions Group Pte. Ltd.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"LabPMM, GmbH","duties_or_roles":"code 4","organisation_type":"Industry"}
- {"country":"Ireland","full_name":"Thermo Fisher Scientific Cork Limited","duties_or_roles":"Prophylaxis Product Supply","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Burning Rock Dx LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH (alternate entry)","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"NGS MRD; code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BGB-11417
- Active Substance
- N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3-NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-YL}-7-AZASPIRO[3.5]NONAN-7-YL)-2-[(1H-PYRROLO[2,3-B]PYRIDIN-5-YL)OXY]BENZAMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Investigational (not authorised)
- Maximum Dose
- 320 mg
- Investigational Product Name
- Zanubrutinib (BGB-3111)
- Active Substance
- ZANUBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Investigational (not authorised)
- Maximum Dose
- 320 mg
- Investigational Product Name
- Venclyxto (Venetoclax) 100 mg film-coated tablets
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation)
- Maximum Dose
- 400 mg
- Investigational Product Name
- Gazyvaro (Obinutuzumab) 1,000 mg concentrate for solution for infusion
- Active Substance
- OBINUTUZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route
- INFUSION
- Authorisation Status
- Authorised (marketing authorisation)
- Maximum Dose
- 1000 mg
- Combination Treatment
- Yes
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