Clinical trial • Phase III • Oncology

BGB-16673 for Chronic lymphocytic leukemia | Small lymphocytic lymphoma

Phase III trial of BGB-16673 for Chronic lymphocytic leukemia | Small lymphocytic lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Chronic lymphocytic leukemia | Small lymphocytic lymphoma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-07-2025
First CTIS Authorization Date
18-11-2025

Trial design

Randomised, open-label, jaypirca (pirtobrutinib) 100 mg film-coated tablets (comparator). dosing/schedule not specified in the available record.-controlled Phase III trial in Austria, Belgium, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Jaypirca (pirtobrutinib) 100 mg film-coated tablets (comparator). Dosing/schedule not specified in the available record.
Target Sample Size
325

Eligibility

Recruits 325 Vulnerable population not selected; consent expected from adult participants. No assent/parental consent procedures are described in the available record..

Vulnerable Population
Vulnerable population not selected; consent expected from adult participants. No assent/parental consent procedures are described in the available record.

Inclusion criteria

  • {"criterion_text":"- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria.\n- Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.\n- Patients with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters."}

Exclusion criteria

  • {"criterion_text":"- Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation.\n- Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL.\n- History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n- Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or non covalent BTKi (ncBTKi). Patients who discontinue cBTKi due solely to toxicity are not eligible\n- History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS, defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL)","definition_or_measurement_approach":"Defined as time from date of randomization to first disease progression or death, whichever occurs first, determined by Independent Review Committee (IRC) using modified 2018 iwCLL criteria for CLL and Lugano classification for SLL."}

Secondary endpoints

  • {"endpoint_text":"- OS, defined as time from the date of randomization to the date of death due to any cause","definition_or_measurement_approach":"Defined as time from date of randomization to date of death due to any cause."}
  • {"endpoint_text":"- PFS determined by investigator assessment","definition_or_measurement_approach":"Progression-free survival as determined by investigator assessment."}
  • {"endpoint_text":"- Overall response rate (partial response [PR] or better) determined by IRC and by investigator assessment, per modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL","definition_or_measurement_approach":"Overall response rate (PR or better) assessed by Independent Review Committee and investigator per modified 2018 iwCLL criteria for CLL and Lugano classification for SLL."}
  • {"endpoint_text":"- Rate of PR with lymphocytosis or higher determined by IRC and by investigator assessment","definition_or_measurement_approach":"Rate of partial response (with lymphocytosis or higher) as determined by IRC and investigator assessment."}
  • {"endpoint_text":"- Duration of response determined by IRC and by investigator assessment","definition_or_measurement_approach":"Duration of response assessed by IRC and investigator."}
  • {"endpoint_text":"- Time to next anti-CLL/SLL treatment (TTNT)","definition_or_measurement_approach":"Time from randomization to start of next anti-CLL/SLL treatment."}
  • {"endpoint_text":"- Incidence and severity of treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory abnormalities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0","definition_or_measurement_approach":"Incidence and severity of TEAEs, serious TEAEs and lab abnormalities graded per NCI-CTCAE v5.0."}
  • {"endpoint_text":"- Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire IL409 (an itemized version of EORTC quality of life questionnaire core 30 [QLQ-C30] and its CLL module CLL17)","definition_or_measurement_approach":"Patient-reported outcomes measured by EORTC IL409 (itemized QLQ-C30 and CLL17 module) assessing global health status, role and physical functioning, symptom burden and fatigue."}

Recruitment

Planned Sample Size
325
Recruitment Window Months
35
Consent Approach
Informed consent to be obtained from participants (adult participants). Subject information and informed consent forms available in multiple languages (examples in the record include English, French, German, Dutch, Italian, Spanish, Polish, Romanian, Swedish). No participant assent or parental consent procedures are described in the available record.

Geography

Total Number Of Sites
63
Total Number Of Participants
196

Austria

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
247
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Internal Medicine I
Principal Investigator Name
Petra Pichler-Izmir
Principal Investigator Email
petra.pichler-izmir@stpoelten.lknoe.at
Contact Person Name
Petra Pichler-Izmir
Site Name
Medical University Of Graz
Department Name
Clinical Department for Hematology
Principal Investigator Name
Annkristin Heine
Principal Investigator Email
annkristin.heine@medunigraz.at
Contact Person Name
Annkristin Heine
Contact Person Email
annkristin.heine@medunigraz.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
IIIrd Medical Department
Principal Investigator Name
Alexander Egle
Principal Investigator Email
a.egle@salk.at
Contact Person Name
Alexander Egle
Contact Person Email
a.egle@salk.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal Department I
Principal Investigator Name
Thomas Bauer
Principal Investigator Email
thomas.bauer@ordensklinikum.at
Contact Person Name
Thomas Bauer
Contact Person Email
thomas.bauer@ordensklinikum.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Internal Medicine V, Hematology and Oncology
Principal Investigator Name
Jan-Paul Bohn
Principal Investigator Email
jan-paul.bohn@i-med.ac.at
Contact Person Name
Jan-Paul Bohn
Contact Person Email
jan-paul.bohn@i-med.ac.at

Belgium

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
38
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Emmaues
Department Name
Hematology
Principal Investigator Name
Toine Mercier
Principal Investigator Email
toine.mercier@emmaus.be
Contact Person Name
Toine Mercier
Contact Person Email
toine.mercier@emmaus.be
Site Name
AZ Groeninge
Department Name
Hematology
Principal Investigator Name
Koen Vaneygen
Principal Investigator Email
Koen.vaneygen@azgroeninge.be
Contact Person Name
Koen Vaneygen
Contact Person Email
Koen.vaneygen@azgroeninge.be
Site Name
CHC MontLegia
Department Name
Hematology
Principal Investigator Name
Renaud Roufosse
Principal Investigator Email
Renaud.roufosse@chc.be
Contact Person Name
Renaud Roufosse
Contact Person Email
Renaud.roufosse@chc.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Principal Investigator Name
Helene Vellemans
Principal Investigator Email
helene.vellemans@chuuclnamur.uclouvain.be
Contact Person Name
Helene Vellemans
Site Name
UZ GENT
Department Name
Hematology
Principal Investigator Name
Willem Daneels
Principal Investigator Email
Willem.Daneels@uzgent.be
Contact Person Name
Willem Daneels
Contact Person Email
Willem.Daneels@uzgent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematology
Principal Investigator Name
Aurelie Jaspers
Principal Investigator Email
aurelie.jaspers@chuliege.be
Contact Person Name
Aurelie Jaspers
Contact Person Email
aurelie.jaspers@chuliege.be
Site Name
Institut Jules Bordet
Department Name
Hematology
Principal Investigator Name
Virginie Dewilde
Principal Investigator Email
Virginie.dewilde@hubruxelles.be
Contact Person Name
Virginie Dewilde

France

Earliest CTIS Part Ii Submission Date
14-10-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
41
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
CHRU De Nancy
Department Name
54
Principal Investigator Name
Pierre FEUGIER
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Pierre FEUGIER
Contact Person Email
xxx@xxx.xx
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
37
Principal Investigator Name
Caroline DARTIGEAS
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Caroline DARTIGEAS
Contact Person Email
xxx@xxx.xx
Site Name
University Hospital Of Clermont-Ferrand
Department Name
63
Principal Investigator Name
Romain GUIEZE
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Romain GUIEZE
Contact Person Email
xxx@xxx.xx
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
31
Principal Investigator Name
Loïc YSEBAERT
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Loïc YSEBAERT
Contact Person Email
xxx@xxx.xx
Site Name
Centre Henri Becquerel
Department Name
76
Principal Investigator Name
Stéphane LEPRETRE
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Stéphane LEPRETRE
Contact Person Email
xxx@xxx.xx
Site Name
Hopital Saint Louis
Department Name
75
Principal Investigator Name
Catherine THIEBLEMONT
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Catherine THIEBLEMONT
Contact Person Email
xxx@xxx.xx
Site Name
Institut Bergonie
Department Name
33
Principal Investigator Name
Fontanet BIJOU
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Fontanet BIJOU
Contact Person Email
xxx@xxx.xx
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
44
Principal Investigator Name
Anne LOK
Principal Investigator Email
xxx@xxx.xx
Contact Person Name
Anne LOK
Contact Person Email
xxx@xxx.xx

Romania

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
109
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Hematology Clinic
Principal Investigator Name
Catalin Doru Danaila
Principal Investigator Email
XXX@yahoo.com
Contact Person Name
Catalin Doru Danaila
Contact Person Email
XXX@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Hematology Clinic
Principal Investigator Name
Ciprian Tomuleasa
Principal Investigator Email
XXX@gmail.com
Contact Person Name
Ciprian Tomuleasa
Contact Person Email
XXX@gmail.com
Site Name
Spitalul Clinic Coltea
Department Name
Hematology Clinic
Principal Investigator Name
Andrei Colita
Principal Investigator Email
XXX@yahoo.com
Contact Person Name
Andrei Colita
Contact Person Email
XXX@yahoo.com
Site Name
Ovidius Clinical Hospital S.R.L.
Department Name
Hematology Clinic
Principal Investigator Name
Andreea Daniela Caloian
Principal Investigator Email
XXX@yahoo.com
Contact Person Name
Andreea Daniela Caloian
Contact Person Email
XXX@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
32
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Hospital Universitario De Burgos
Department Name
Hematology and Hematherapy
Principal Investigator Name
Francisco Javier Díaz
Principal Investigator Email
fcdiaz@saludcastillayleon.es
Contact Person Name
Francisco Javier Díaz
Contact Person Email
fcdiaz@saludcastillayleon.es
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hematology
Principal Investigator Name
Alexia Suárez Cabrera
Principal Investigator Email
asuacab@gobiernodecanarias.org
Contact Person Name
Alexia Suárez Cabrera
Contact Person Email
asuacab@gobiernodecanarias.org
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Marta Juliá Arenas
Principal Investigator Email
mjulia@iconcologia.net
Contact Person Name
Marta Juliá Arenas
Contact Person Email
mjulia@iconcologia.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology and Hematherapy
Principal Investigator Name
Guillermo Rodríguez García
Principal Investigator Email
XXX@xxxxx
Contact Person Name
Guillermo Rodríguez García
Contact Person Email
XXX@xxxxx
Site Name
University Hospital Son Espases
Department Name
Hematology
Principal Investigator Name
Antonio Gutiérrez
Principal Investigator Email
antoniom.gutierrez@ssib.es
Contact Person Name
Antonio Gutiérrez
Contact Person Email
antoniom.gutierrez@ssib.es
Site Name
University Hospital Puerta De Hierro De Majadahonda
Department Name
Hematology and Hematherapy
Principal Investigator Name
José Antonio García Vela
Principal Investigator Email
XXX@xxxxx
Contact Person Name
José Antonio García Vela
Contact Person Email
XXX@xxxxx
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Principal Investigator Name
Sergio Ramos
Principal Investigator Email
sergio.ramos@quironsalud.com
Contact Person Name
Sergio Ramos
Contact Person Email
sergio.ramos@quironsalud.com
Site Name
Hospital Universitario De Sevilla (Virgen Del Rocio) [listed as University Hospital Virgen Del Rocio S.L.]
Department Name
Hematology and Hematherapy
Principal Investigator Name
Guillermo Rodríguez García
Principal Investigator Email
XXX@xxxxx
Contact Person Name
Guillermo Rodríguez García
Contact Person Email
XXX@xxxxx

Netherlands

Earliest CTIS Part Ii Submission Date
14-10-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
99
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Catharina Ziekenhuis Stichting
Department Name
Hemato-oncology
Principal Investigator Name
Marten Nijziel
Principal Investigator Email
marten.nijziel@catherinaziekenhuis.nl
Contact Person Name
Marten Nijziel
Site Name
Groene Hart Ziekenhuis
Department Name
Hematology
Principal Investigator Name
Henriëtte Levenga
Principal Investigator Email
henriette.levenga@ghz.nl
Contact Person Name
Henriëtte Levenga
Contact Person Email
henriette.levenga@ghz.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Principal Investigator Name
Mar Bellido
Principal Investigator Email
m.bellido@umcg.nl
Contact Person Name
Mar Bellido
Contact Person Email
m.bellido@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hematology
Principal Investigator Name
Sanne de Haart
Principal Investigator Email
s.j.dehaart@umcutrecht.nl
Contact Person Name
Sanne de Haart
Contact Person Email
s.j.dehaart@umcutrecht.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
Hematology
Principal Investigator Name
Susan de Jonge-Peeters
Principal Investigator Email
researchverpleegkundige-oncologie@cwz.nl
Contact Person Name
Susan de Jonge-Peeters
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Hematology
Principal Investigator Name
Mark-David Levin
Principal Investigator Email
m-d.levin@asz.nl
Contact Person Name
Mark-David Levin
Contact Person Email
m-d.levin@asz.nl
Site Name
Canisius Wilhelmina Ziekenhuis (alternate listing)
Department Name
Hematology
Principal Investigator Name
Susan de Jonge-Peeters
Principal Investigator Email
researchverpleegkundige-oncologie@cwz.nl
Contact Person Name
Susan de Jonge-Peeters

Germany

Earliest CTIS Part Ii Submission Date
14-10-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
56
Number Of Sites
9
Number Of Participants
26

Sites

Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Nicola Giesen
Principal Investigator Email
nicola.giesen@rbk.de
Contact Person Name
Nicola Giesen
Contact Person Email
nicola.giesen@rbk.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Hämatologie und Onkologie
Principal Investigator Name
Julia von Tresckow
Principal Investigator Email
julia.vontresckow@klinikum-bochum.de
Contact Person Name
Julia von Tresckow
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik III, Hämatologie und Onkologie
Principal Investigator Name
Ruth-Miriam Körber
Principal Investigator Email
ruth-miriam.koerber@ukbonn.de
Contact Person Name
Ruth-Miriam Körber
Contact Person Email
ruth-miriam.koerber@ukbonn.de
Site Name
Medizinische Studiengesellschaft Nord-West GmbH
Principal Investigator Name
Jan Janssen
Principal Investigator Email
gensch-janssen@t-online.de
Contact Person Name
Jan Janssen
Contact Person Email
gensch-janssen@t-online.de
Site Name
Lübecker Onkologische Schwerpunktpraxis
Principal Investigator Name
Jens Kisro
Principal Investigator Email
jens.kisro@t-online.de
Contact Person Name
Jens Kisro
Contact Person Email
jens.kisro@t-online.de
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Medizinische Klinik III
Principal Investigator Name
Henriette Huber
Principal Investigator Email
henriette.huber@klinikum-karlsruhe.de
Contact Person Name
Henriette Huber
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Innere Medizin III
Principal Investigator Name
Eugen Tausch
Principal Investigator Email
eugen.tausch@uniklin-ulm.de
Contact Person Name
Eugen Tausch
Contact Person Email
eugen.tausch@uniklin-ulm.de
Site Name
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH
Principal Investigator Name
Sandra Ketzler-Henkel
Principal Investigator Email
ketzler@onkologie-dortmund.de
Contact Person Name
Sandra Ketzler-Henkel
Contact Person Email
ketzler@onkologie-dortmund.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Principal Investigator Name
Petra Langerbeins
Principal Investigator Email
petra.langerbeins@uk-koeln.de
Contact Person Name
Petra Langerbeins
Contact Person Email
petra.langerbeins@uk-koeln.de

Sweden

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
205
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Hematology
Principal Investigator Name
Per-Ola Andersson
Principal Investigator Email
per-ola.andersson@vgregion.se
Contact Person Name
Per-Ola Andersson
Contact Person Email
per-ola.andersson@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Hematology
Principal Investigator Name
Anders Österborg
Principal Investigator Email
anders.osterborg@regionstockholm.se
Contact Person Name
Anders Österborg

Italy

Earliest CTIS Part Ii Submission Date
02-10-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
224
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
CTU Ematologia
Principal Investigator Name
Marina Deodato
Principal Investigator Email
marina.deodato@ospedaleniguarda.it
Contact Person Name
Marina Deodato
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
U.O.C. di Ematologia - Pad. 8
Principal Investigator Name
Pierluigi Zinzani
Principal Investigator Email
pierluigi.zinzani@unibo.it
Contact Person Name
Pierluigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Strategic Research Program on CLL Department
Principal Investigator Name
Paolo Prospero Ghia
Principal Investigator Email
ghia.paolo@hsr.it
Contact Person Name
Paolo Prospero Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O.C. Ematologia
Principal Investigator Name
Andrea Visentin
Principal Investigator Email
andrea.visentin@aopd.veneto.it
Contact Person Name
Andrea Visentin
Contact Person Email
andrea.visentin@aopd.veneto.it

Poland

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
281
Number Of Sites
9
Number Of Participants
43

Sites

Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Oddział Hematologii
Principal Investigator Name
Weronika PISZCZEK
Principal Investigator Email
x@x
Contact Person Name
Weronika PISZCZEK
Contact Person Email
x@x
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Klinika Nowotworów Układu Chłonnego
Principal Investigator Name
Ewa PASZKIEWICZ-KOZIK
Principal Investigator Email
x@x
Contact Person Name
Ewa PASZKIEWICZ-KOZIK
Contact Person Email
x@x
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku
Principal Investigator Name
Janusz HAŁKA
Principal Investigator Email
x@x
Contact Person Name
Janusz HAŁKA
Contact Person Email
x@x
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Klinika Hematoonkologii i Transplantacji Szpiku
Principal Investigator Name
Waldemar TOMCZAK
Principal Investigator Email
x@x
Contact Person Name
Waldemar TOMCZAK
Contact Person Email
x@x
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii Ogólnej i Chorób Wewnętrznych
Principal Investigator Name
Tadeusz ROBAK
Principal Investigator Email
x@x
Contact Person Name
Tadeusz ROBAK
Contact Person Email
x@x
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Wojewódzkie Centrum Onkologii, Oddział Onkologii Klinicznej/Chemioterapii
Principal Investigator Name
Hanna CIEPŁUCH
Principal Investigator Email
x@x
Contact Person Name
Hanna CIEPŁUCH
Contact Person Email
x@x
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz WRÓBEL
Principal Investigator Email
x@x
Contact Person Name
Tomasz WRÓBEL
Contact Person Email
x@x
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Hematologii i Transplantacji Szpiku
Principal Investigator Name
Paweł STECKIEWICZ
Principal Investigator Email
badania.kliniczne@onkol.kielce.pl
Contact Person Name
Paweł STECKIEWICZ

Sponsor

Primary sponsor

Full Name
BeOne Medicines AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
PPD Development LP
Responsibilities
PK sample storage for Germany; PK sample testing for Germany
Name
4g Clinical LLC
Responsibilities
code:3
Name
Clinchoice Inc.
Responsibilities
code:6
Name
Medidata Solutions Inc.
Responsibilities
code:7
Name
Perceptive Informatics Inc.
Responsibilities
code:13

Third parties

  • {"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":"Clinchoice Inc.","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code:15; value: MRD testing; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Beone Medicines USA Inc.","duties_or_roles":"code:15; value: Biomarker Sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"code:13","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:15; value: PK sample storage for Germany","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code:15; value: Potential lab for pharmacodynamic testing","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Burning Rock Dx LLC","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"code:4","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":"Burning Rock Dx LLC (alternate entry)","duties_or_roles":"code:15; value: Biomarker sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP (alternate entry)","duties_or_roles":"code:15; value: PK sample testing for Germany","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BGB-16673
Active Substance
BGB-16673
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Investigational (not marketed for this indication in record)
Maximum Dose
200 mg (maxDailyDoseAmount reported)
Investigational Product Name
Jaypirca 100 mg film-coated tablets
Active Substance
PIRTOBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Authorised (marketing authorisation EU/1/23/1738/006 reported)
Starting Dose
100 mg
Maximum Dose
200 mg (maxDailyDoseAmount reported)

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