A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Phase 3 – large-scale trial before approval
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Sponsor: BeOne Medicines
trial.available_in:
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Overview
The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Who can participate
Inclusion Criteria:
* Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
* 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.
* Participants 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:
* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
* 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
* History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
* Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
* 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Interventions
BGB-16673
DRUG
Pirtobrutinib
DRUG
Locations
145
Australia (10)
Flinders Medical Centre
Bedford PK , South Australia
Sunshine Coast Hospital and Health Service
Birtinya , Queensland
Concord Repatriation General Hospital
Concord , New South Wales
St Vincents Hospital Melbourne
Fitzroy , Victoria
Peninsula Private Hospital
Frankston , Victoria
Austin Health
Heidelberg , Victoria
Cabrini Hospital Malvern
Malvern East , Victoria
Peter Maccallum Cancer Centre
Melbourne , Victoria
The Alfred Hospital
Melbourne , Victoria
Linear Clinical Research
Nedlands , Western Australia
Austria (3)
Medizinische Universitatsklinik Innsbruck
Innsbruck
Ordensklinikum Linz Gmbh Elisabethinen
Linz
Uk St Poelten
Sankt Pölten
Belgium (6)
Institut Jules Bordet
Anderlecht
UZ GENT
Ghent
Az Groeninge Campus Loofstraat
Kortrijk
Chc Montlegia
Liège
Chu de Liege
Liège
Chu Ucl Namur
Yvoir
Brazil (7)
Centro de Pesquisa Clinica Dom Bosco Ltda
Araçatuba
Ictr Instituto Do Cancer E Transplante de Curitiba
Curitiba
Hospital de Clinicas de Goiania Ufg
Goiânia
Inca Instituto Nacional de Cancer
Rio de Janeiro
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador
Hospital Nove de Julho Dasa
São Paulo
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
São Paulo
France (8)
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux
Hopital Estaing
Clermontferrand
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes
Hopital Saint Louis
Paris
Centre Henri Becquerel
Rouen
Iuc Toulouse Oncopole
Toulouse
Chu Tours Hopital Bretonneau
Tours
Chu Nancy Hopital Brabois
VandoeuvrelesNancy
Germany (4)
Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund
Dortmund
Luebecker Onkologische Schwerpunktpraxis Dres Med Kisroweber
Lübeck
Universitaetsklinikum Ulm
Ulm
Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede
Westerstede
Israel (7)
Bnai Zion Medical Center
Haifa
Shaare Zedek Medical Center
Jerusalem
Hadassah University Hospital Ein Kerem
Jerusalem
Meir Medical Center
KfarSava
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Sourasky Tel Aviv Medical Center
Tel Aviv
Italy (4)
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna
Ospedale San Raffaele
Milan
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan
Azienda Ospedaliera Di Padova
Padova
Japan (17)
Tokyo Metropolitan Komagome Hospital
Bunkyoku , Tokyo
Fukushima Medical University Hospital
Fukushima , Fukushima
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima , Hiroshima
Dokkyo Medical University Saitama Medical Center
Koshigaya , Saitama
Cancer Institute Hospital of Jfcr
Kotoku , Tokyo
Kumamoto University Hospital
Kumamoto
Japanese Red Cross Kyoto Daini Hospital
Kyotoshi , Kyoto
Matsuyama Red Cross Hospital
Matsuyama , Ehime
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nakamuraku , Aichi-ken
Kochi Medical School Hospital
Nankoku , Kochi
Oita Prefectural Hospital
Ōita
Okayama University Hospital
Okayama , Okayama-ken
Osaka Metropolitan University Hospital
Osaka
Kindai University Hospital
Sakai , Osaka
Aiiku Hospital
Sapporo , Hokkaido
National Hospital Organization (Nho) Disaster Medical Center
Tachikawashi , Tokyo
Yamagata University Hospital
Yamagata , Yamagata
Netherlands (6)
Albert Schweitzer Ziekenhuis
Dordrecht
Catharina Hospital
EJ Eindhoven
Groene Hart Hospital
Gouda
University of Medical Center Groningen (Umcg)
Groningen
Canisius Wilhelmina Ziekenhuis
Nijmegen
Universitair Medisch Centrum Utrecht
Utrecht
New Zealand (3)
North Shore Hospital
Auckland
Tauranga Hospital
Tauranga
Wellington Regional Hospital (Ccdhb)
Wellington
Poland (8)
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdansk
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Kielce
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W Lublinie
Lublin
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
Olsztyn
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw
Puerto Rico (1)
Auxilio Mutuo Cancer Center
San Juan
Romania (3)
Coltea Clinical Hospital
Bucharest
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca
Institutul Regional de Oncologie Iasi
Iași
Singapore (2)
Singapore General Hospital
Singapore
Tan Tock Seng Hospital Haematology
Singapore
South Korea (6)
Gyeongsang National University Hospital
Jinju , Gyeongsangnam-do
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu , Seoul Teugbyeolsi
Severance Hospital Yonsei University Health System
SeodaemunGu , Seoul Teugbyeolsi
Pusan National University Hospital
Seogu , Busan Gwang'yeogsi
Seoul National University Bundang Hospital
Seongnam-si , Gyeonggi-do
Seoul National University Hospital
Seoul , Seoul Teugbyeolsi
Spain (7)
Ico Badalona
Badalona
Hospital Universitario de Burgos
Burgos
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
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