Clinical trial • Phase III • Oncology
ZANUBRUTINIB for B-cell malignancies
Phase III trial of ZANUBRUTINIB for B-cell malignancies. open-label, none/not specified-controlled. 444 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- B-cell malignancies
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-02-2024
- First CTIS Authorization Date
- 07-03-2024
Trial design
open-label, none/not specified-controlled Phase III trial in Germany, Greece, Netherlands and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 444
Eligibility
Recruits 444 adults.
- Pregnancy Exclusion
- Pregnant or lactating woman
Inclusion criteria
- {"criterion_text":"- As part of a BeiGene-sponsored parent study: a. Currently participating, or b. Participated recently\n- Intent to continue or start zanubrutinib treatment after occurrence of any of the following: a. At time of final analysis or study closure of the eligible BeiGene-sponsored parent study. b. At time of progressive disease (PD) after occurrence of either of the following: i. Patient was receiving zanubrutinib at the time of progressive disease (PD), and the investigator and patient agree it is in the patient's best interest to continue zanubrutinib (following discussion with the medical monitor or designee of the parent study and this study) *The following signs and symptoms may be indicators of non-clinically significant progression warranting continued use of zanubrutinib despite radiologic progression: absence of clinical symptoms and signs of disease progression (including clinically significant worsening of laboratory values), stable Eastern Cooperative Oncology Group Performance Scale (ECOG PS), absence of rapid progression of disease or of progressive tumor at critical anatomical sites that requires urgent alternative medical intervention. In these scenarios, investigators must inform patients that continuing treatment is not considered standard in the treatment of cancer but that in the opinion of the investigator, the patient will continue to benefit from zanubrutinib. ii. Patient was receiving a non-BTK inhibitor drug at the time of PD, and the investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (following discussion with the medical monitor or designee of the parent study and this study) c. At an alternative timepoint for an alternative reason not described in Inclusion Criteria 2a and 2b (following discussion with the medical monitor or designee)\n- In the opinion of the investigator, the patient will continue to benefit from, and tolerate zanubrutinib a. Patient who is currently on zanubrutinib treatment: Does not meet any criteria for zanubrutinib hold or permanent discontinuation"}
Exclusion criteria
- {"criterion_text":"- Permanently discontinued from zanubrutinib treatment in the BeiGene-sponsored parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent\n- Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy\n- Life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk\n- Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapy, or any prohibited concomitant therapy outlined in the protocol\n- Pregnant or lactating woman\n- Inability to comply with study procedures\n- Concurrent participation in another therapeutic clinical study\n- History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)\n- Vaccination with a live vaccine within 35 days prior to first dose of study drug"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of the study is safety as assessed by incidence of all TEAEs and SAEs.","definition_or_measurement_approach":"Safety assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)."}
Secondary endpoints
- {"endpoint_text":"- Progression-free Survival per investigator assessment","definition_or_measurement_approach":"Progression-free survival assessed by investigator evaluation (time from entry to disease progression or death as determined by investigator)."}
- {"endpoint_text":"- Duration of Response per investigator assessment","definition_or_measurement_approach":"Duration of response assessed by investigator (time from first documented response to progression or death)."}
- {"endpoint_text":"- Overall Survival","definition_or_measurement_approach":"Overall survival measured as time from entry/randomisation to death from any cause."}
Recruitment
- Planned Sample Size
- 444
- Recruitment Window Months
- 89
Geography
- Total Number Of Sites
- 51
- Total Number Of Participants
- 343
Germany
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- SRH Kliniken Landkreis Sigmaringen GmbH
- Department Name
- Innere Medizin | Hämatologie und Internistische Onkologie, Palliativmedizin
- Contact Person Name
- Gabriele Käfer
- Contact Person Email
- xxx@srh.de
Greece
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 23-04-2024
- Processing Time Days
- 57
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics
- Contact Person Name
- Athanasios-Meletios Dimopoulos
- Contact Person Email
- mdimop@med.uoa.gr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 14
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Hematology
- Contact Person Name
- Monique Minnema
- Contact Person Email
- m.c.minnema@umcutrecht.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Hematology
- Contact Person Name
- Marie José Kersten
- Contact Person Email
- m.j.kersten@amc.uva.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Hematology
- Contact Person Name
- Mark-David Levin
- Contact Person Email
- m-d.levin@asz.nl
France
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 24
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Onco-Hématologie
- Contact Person Name
- Bruno VILLEMAGNE
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Onco-Hématologie
- Contact Person Name
- Catherine THIEBLEMONT
- 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
- 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
- Institut Bergonie
- Department Name
- Hématologie
- Contact Person Name
- Fontanet BIJOU
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hématologie Clinique
- Contact Person Name
- Emmanuelle FERRANT
- Contact Person Email
- xxxxxx@xxxxxxx.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 14
- Number Of Sites
- 10
- Number Of Participants
- 39
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- SC Oncologia Medica
- Contact Person Name
- Michela Ceccolini
- Contact Person Email
- michela.ceccolini@irst.emr.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- UNITA DI EMATOLOGIA, DIPARTIMENTO DI EMATOLOGIA ED ONCOLOGIA
- Contact Person Name
- Monica Tani
- Contact Person Email
- monica.tani@auslromagna.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- S.C. Ematologia
- Contact Person Name
- Gloria Margiotta Casaluci
- Contact Person Email
- gloria.margiotta@med.uniupo.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Department of Molecular Biotechnology and Health Sciences
- Contact Person Name
- Federica Cavallo
- Contact Person Email
- f.cavallo@unito.it
- Site Name
- Azienda Ospedaliera Universitaria Di Modena
- Department Name
- S.C. Ematologia
- Contact Person Name
- Roberto Marasca
- Contact Person Email
- roberto.marasca@unimore.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA
- Contact Person Name
- Luca Laurenti
- Contact Person Email
- LUCA.LAURENTI@UNICATT.IT
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- S.C. Ematologia
- Contact Person Name
- Anna Maria Frustaci
- Contact Person Email
- Annamaria.frustaci@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliera S Maria Di Terni
- Department Name
- Department of Medicine
- Contact Person Name
- Gaetano Vaudo
- Contact Person Email
- vaudogaetano@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Dip Malattie Oncologiche ed Ematologiche
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- SOC Clinica Ematologica
- Contact Person Name
- Jacopo Olivieri
- Contact Person Email
- jacopo.olivieri@asufc.sanita.fvg.it
Czechia
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 07-03-2024
- Processing Time Days
- 10
- Number Of Sites
- 6
- Number Of Participants
- 43
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- Hemato-onkologicka klinika
- Contact Person Name
- Peter Turcsanyi
- Contact Person Email
- peter.turcsanyi@fnol.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie FNO a LF OU
- Contact Person Name
- Roman Hajek
- Contact Person Email
- roman.hajek@fno.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Hematologicka klinika
- Contact Person Name
- Heidi Mocikova
- Contact Person Email
- Heidi.mocikova@fnkv.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. Interni klinika – klinika hematologie
- Contact Person Name
- Marek Trneny
- Contact Person Email
- trneny@cesnet.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interni hematologicka a onkologicka klinika
- Contact Person Name
- Anna Panovska
- Contact Person Email
- panovska.anna@fnbrno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. interni hematologicka klinika
- Contact Person Name
- David Belada
- Contact Person Email
- BeladaD@lfhk.cuni.cz
Sweden
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 07-03-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Center for clinical cancer studies
- Contact Person Name
- Bjorn Wahlin
- Contact Person Email
- bjorn.wahlin@sll.se
Spain
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 14
- Number Of Sites
- 12
- Number Of Participants
- 40
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Contact Person Name
- Albert Oriol
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Hematology
- Contact Person Name
- Maria Isabel Gomez
- Contact Person Email
- mgroncero@telefonica.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Contact Person Name
- Mario Arnao
- Contact Person Email
- arnao_mar@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Contact Person Name
- Mercedes Gironella
- Contact Person Email
- mgironella@vhio.net
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Hematology
- Contact Person Name
- Jose Antonio Garcia Vela
- Contact Person Email
- xxxx@xxx.xx
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Hematology
- Contact Person Name
- Jordi Lopez
- Contact Person Email
- JLopezPar@santpau.cat
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Contact Person Name
- Cristina de Ramon
- Contact Person Email
- cramon@saludcastillayleon.es
- Site Name
- Institut Catala D'oncologia (Girona)
- Department Name
- Hematology
- Contact Person Name
- Josep Maria Roncero
- Contact Person Email
- jroncero@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology
- Contact Person Name
- Javier Lopez
- Contact Person Email
- jlopezj.hrc@salud.madrid.org
- Site Name
- Institut Catala D'oncologia (L'hospitalet De Llobregat)
- Department Name
- Hematology
- Contact Person Name
- Ana Carla Oliveira
- Contact Person Email
- acoliveira@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Contact Person Name
- Pablo Javier Mozas
- Contact Person Email
- mozas@clinic.cat
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Hematology
- Contact Person Name
- Albert Oriol
- Contact Person Email
- aoriol@iconcologia.net
Poland
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 12-03-2024
- Processing Time Days
- 15
- Number Of Sites
- 11
- Number Of Participants
- 164
Sites
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii Ogólnej i Chorób Wewnętrznych
- Contact Person Name
- Tadeusz ROBAK
- Contact Person Email
- x@x
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- -
- Contact Person Name
- Paweł KICIŃSKI
- Contact Person Email
- x@x
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Hematologii
- Contact Person Name
- Marta SOBAS
- Contact Person Email
- x@x
- Site Name
- Interhem Katarzyna Mazgajska-Barczyk Marek Milewski Jaroslaw Piszcz Janusz Kloczko Piotr Radziwon Sp. j.
- Department Name
- InterHem Opieka Szpitalna
- Contact Person Name
- Jarosław PISZCZ
- Contact Person Email
- x@x
- Site Name
- Aidport Sp. z o.o.
- Department Name
- -
- Contact Person Name
- Maciej Kaźmierczak
- Contact Person Email
- rejestracja@aidport.pl
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Department Name
- Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej
- Contact Person Name
- Jacek KRZANOWSKI
- Contact Person Email
- badaniadsawka@szpital-brzozow.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
- Department Name
- Oddział Kliniczny Hematologii i Profilaktyki Chorób Nowotworowych
- Contact Person Name
- Aleksandra MELISZ
- Contact Person Email
- x@x
- Site Name
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej/Chemioterapii
- Contact Person Name
- Hanna Ciepłuch
- Contact Person Email
- XX@XX
- Site Name
- Pratia S.A.
- Department Name
- -
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- XX@XX
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Contact Person Name
- Andrzej Mital
- Contact Person Email
- XX@XX
- Site Name
- Additional listed Polish sites
Sponsor
Primary sponsor
- Full Name
- BeOne Medicines AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- codes:1,2
- Name
- PPD (UK) Limited
- Responsibilities
- code:8
- Name
- IQVIA Limited
- Responsibilities
- code:12
Third parties
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient engagement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"codes:1,2","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Biomarkers sample storage","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Zanubrutinib
- Active Substance
- ZANUBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Starting Dose
- 320 mg once daily or 160 mg twice daily (total daily dose 320 mg); for patients with prior zanubrutinib treatment, equivalent to the last dose level received in the BeiGene-sponsored parent study.
- Dose Levels
- 320 mg once daily; 160 mg twice daily (total 320 mg/day)
- Frequency
- Once daily or twice daily (for 160 mg BID)
- Maximum Dose
- 320 mg daily
- Combination Treatment
- Yes
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