Clinical trial • Phase III • Oncology
PIRTOBRUTINIB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma
Phase III trial of PIRTOBRUTINIB 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 | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-05-2024
- First CTIS Authorization Date
- 12-06-2024
Trial design
Randomised, open-label, venetoclax plus rituximab (comparator arm) — venetoclax (film-coated tablet, oral, max daily dose reported 400 mg) and rituximab (solution for infusion, iv, dose reported up to 500 mg/m2)-controlled Phase III trial in Sweden, Denmark, Belgium and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Venetoclax plus Rituximab (comparator arm) — Venetoclax (FILM-COATED TABLET, oral, max daily dose reported 400 mg) and Rituximab (SOLUTION FOR INFUSION, IV, dose reported up to 500 mg/m2)
- Target Sample Size
- 377
- Trial Duration For Participant
- 784
Eligibility
Recruits 377 adults.
Inclusion criteria
- {"criterion_text":"- Age 18 and older at time of enrollment\n- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria\n- Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor\n- Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L\n- Adequate organ function\n- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n- Estimated creatinine clearance ≥30 milliliters per minute (mL/min)"}
Exclusion criteria
- {"criterion_text":"- Known or suspected Richter's transformation at any time preceding enrollment\n- Patients with the following hypersensitivity: 1. Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax 2. Prior significant hypersensitivity to rituximab 3. Known allergy to allopurinol and inability to take uric acid lowering agent\n- Prior therapy with a non-covalent (reversible) BTK inhibitor\n- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist\n- Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers\n- Prior therapy with venetoclax\n- Central nervous system (CNS) involvement\n- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count\n- Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days\n- Active hepatitis B or hepatitis C\n- Known active cytomegalovirus (CMV) infection\n- Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)\n- Significant cardiovascular disease\n- Vaccination with a live vaccine within 28 days prior to randomization"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018, assessed by Independent Review Committee (IRC)","definition_or_measurement_approach":"Assessed per iwCLL 2018 criteria and evaluated by an Independent Review Committee (IRC)"}
Recruitment
- Planned Sample Size
- 377
- Recruitment Window Months
- 62
- Consent Approach
- Adults (age ≥18) provide informed consent. Subject information and informed consent forms (ICFs) are submitted in multiple country/language versions (documents available in English, French, Spanish, Hungarian, Polish, Italian, Swedish, Czech, Dutch per submitted ICF documents).
Geography
- Total Number Of Sites
- 69
- Total Number Of Participants
- 262
Sweden
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematology
- Principal Investigator Name
- Daniel Roth
- Principal Investigator Email
- Daniel.Roth@skane.se
- Contact Person Name
- Daniel Roth
- Contact Person Email
- Daniel.Roth@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Anders Osterborg
- Principal Investigator Email
- anders.osterborg@regionstockholm.se
- Contact Person Name
- Anders Osterborg
- Contact Person Email
- anders.osterborg@regionstockholm.se
Denmark
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 14-06-2024
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Rigshospitalet
- Department Name
- Hematology
- Principal Investigator Name
- Caspar Cunha-Bang M.D
- Principal Investigator Email
- caspar.da.cunha-bang@regionh.dk
- Contact Person Name
- Caspar Cunha-Bang M.D
- Contact Person Email
- caspar.da.cunha-bang@regionh.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 14
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Principal Investigator Name
- Fritz Offnner
- Principal Investigator Email
- fritz.offner@ugent.be
- Contact Person Name
- Fritz Offnner
- Contact Person Email
- fritz.offner@ugent.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Principal Investigator Name
- Hélène Vellemans
- Principal Investigator Email
- helene.vellemans@chuuclnamur.uclouvain.be
- Contact Person Name
- Hélène Vellemans
- Contact Person Email
- helene.vellemans@chuuclnamur.uclouvain.be
- Site Name
- Pole Hospitalier Jolimont
- Department Name
- Hematology
- Principal Investigator Name
- Vanessa Delrieu
- Principal Investigator Email
- vanessa.delrieu@helora.be
- Contact Person Name
- Vanessa Delrieu
- Contact Person Email
- vanessa.delrieu@helora.be
Italy
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 28
- Number Of Sites
- 13
- Number Of Participants
- 40
Sites
- Site Name
- Azienda Ospedaliera Santa Croce E Carle
- Department Name
- SC Ematologia
- Principal Investigator Name
- Elia Boccellato
- Principal Investigator Email
- elia.boccellato@gmail.com
- Contact Person Name
- Elia Boccellato
- Contact Person Email
- elia.boccellato@gmail.com
- Site Name
- Careggi University Hospital
- Department Name
- SODc Ematologia
- Principal Investigator Name
- Alessandro Sanna
- Principal Investigator Email
- sannaa@aou-careggi.toscana.it
- Contact Person Name
- Alessandro Sanna
- Contact Person Email
- sannaa@aou-careggi.toscana.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Hematology
- Principal Investigator Name
- Candida Vitale
- Principal Investigator Email
- candida.vitale@unito.it
- Contact Person Name
- Candida Vitale
- Contact Person Email
- candida.vitale@unito.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Luca Laurenti
- Principal Investigator Email
- luca.laurenti@unicatt.it
- Contact Person Name
- Luca Laurenti
- Contact Person Email
- luca.laurenti@unicatt.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncologia
- Principal Investigator Name
- Pierpaolo Ghia
- Principal Investigator Email
- ghia.paolo@hsr.it
- Contact Person Name
- Pierpaolo Ghia
- Contact Person Email
- ghia.paolo@hsr.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- SC Ematologia
- Principal Investigator Name
- Roberto Marasca
- Principal Investigator Email
- roberto.marasca@unimore.it
- Contact Person Name
- Roberto Marasca
- Contact Person Email
- roberto.marasca@unimore.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- SC Ematologia
- Principal Investigator Name
- Anna Maria Frustaci
- Principal Investigator Email
- annamaria.frustaci@ospedaleniguarda.it
- Contact Person Name
- Anna Maria Frustaci
- Contact Person Email
- annamaria.frustaci@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UO Ematologia
- Principal Investigator Name
- Pier Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Ematologia
- Principal Investigator Name
- Gianluca Gaidano
- Principal Investigator Email
- gianluca.gaidano@med.uniupo.it
- Contact Person Name
- Gianluca Gaidano
- Contact Person Email
- gianluca.gaidano@med.uniupo.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia medica
- Principal Investigator Name
- Gerardo Musuraca
- Principal Investigator Email
- gerardo.musuraca@irst.emr.it
- Contact Person Name
- Gerardo Musuraca
- Contact Person Email
- gerardo.musuraca@irst.emr.it
- Site Name
- Azienda ospedaliera universitaria Renato Dulbecco
- Department Name
- Oncoematologia
- Principal Investigator Name
- Marco Rossi
- Principal Investigator Email
- rossim@unicz.it
- Contact Person Name
- Marco Rossi
- Contact Person Email
- rossim@unicz.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Divisione di Ematologia
- Principal Investigator Name
- Maurizio Martelli
- Principal Investigator Email
- martelli@bce.uniroma1.it
- Contact Person Name
- Maurizio Martelli
- Contact Person Email
- martelli@bce.uniroma1.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- UO Ematologia
- Principal Investigator Name
- Antonio Cuneo
- Principal Investigator Email
- cut@unife.it
- Contact Person Name
- Antonio Cuneo
- Contact Person Email
- cut@unife.it
Poland
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 28
- Number Of Sites
- 7
- Number Of Participants
- 63
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Klinika Hematoonkologii i Transplantacji Szpiku
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- markhus@o2.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- markhus@o2.pl
- Site Name
- Pratia S.A.
- Principal Investigator Name
- Wojciech Jurczak
- Principal Investigator Email
- wojciech.jurczak@pratia.com
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- wojciech.jurczak@pratia.com
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Ewa Lech-Marańda
- Principal Investigator Email
- emaranda@ihit.waw.pl
- Contact Person Name
- Ewa Lech-Marańda
- Contact Person Email
- emaranda@ihit.waw.pl
- Site Name
- Pratia Hematologia Sp. z o.o.
- Principal Investigator Name
- Sebastian Grosicki
- Principal Investigator Email
- sgrosicki@wp.pl
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- sgrosicki@wp.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Principal Investigator Name
- Dominik Chraniuk
- Principal Investigator Email
- d.chraniuk@naszlekarz.pl
- Contact Person Name
- Dominik Chraniuk
- Contact Person Email
- d.chraniuk@naszlekarz.pl
- Site Name
- Szpitale Pomorskie Sp. z o.o.
- Department Name
- Oddział Hematologii i Transplantologii Szpiku
- Principal Investigator Name
- Adam Witkowski
- Principal Investigator Email
- adam.wit12@gmail.com
- Contact Person Name
- Adam Witkowski
- Contact Person Email
- adam.wit12@gmail.com
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii z Pododdziałem Chemoterapii - Klinika Hematologii
- Principal Investigator Name
- Tadeusz Robak
- Principal Investigator Email
- robaktad@csk.umed.lodz.pl
- Contact Person Name
- Tadeusz Robak
- Contact Person Email
- robaktad@csk.umed.lodz.pl
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 9
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- University Of Debrecen
- Department Name
- Belgyógyászati Klinika. B épület. Hematológia
- Principal Investigator Name
- Árpád Illés
- Principal Investigator Email
- illes@IIIbel.dote.hu
- Contact Person Name
- Árpád Illés
- Contact Person Email
- illes@IIIbel.dote.hu
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Hematológia és Lymphoma osztály "Kemoterápia A"
- Principal Investigator Name
- András Masszi
- Principal Investigator Email
- masszi.andras@oncol.hu
- Contact Person Name
- András Masszi
- Contact Person Email
- masszi.andras@oncol.hu
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Department Name
- Haematológiai Osztály
- Principal Investigator Name
- Balázs Kollár
- Principal Investigator Email
- kollarbalazs@yahoo.com
- Contact Person Name
- Balázs Kollár
- Contact Person Email
- kollarbalazs@yahoo.com
Ireland
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 14-06-2024
- Processing Time Days
- 11
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- University Hospital Waterford
- Department Name
- Haem
- Principal Investigator Name
- Ezzat Elhassadi
- Principal Investigator Email
- ezzat.elhassadi@hse.ie
- Contact Person Name
- Ezzat Elhassadi
- Contact Person Email
- ezzat.elhassadi@hse.ie
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Haematology
- Principal Investigator Name
- Anne Fortune
- Principal Investigator Email
- afortune@mater.ie
- Contact Person Name
- Anne Fortune
- Contact Person Email
- afortune@mater.ie
Germany
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik I für innere Medizin
- Principal Investigator Name
- Paula Cramer
- Principal Investigator Email
- paula.cramer@uk-koeln.de
- Contact Person Name
- Paula Cramer
- Contact Person Email
- paula.cramer@uk-koeln.de
- Site Name
- Rostock University Medical Center
- Department Name
- ZIM III für Hämatologie
- Principal Investigator Name
- Sebastian Boettcher
- Principal Investigator Email
- sebastian.boettcher@med.uni-rostock.de
- Contact Person Name
- Sebastian Boettcher
- Contact Person Email
- sebastian.boettcher@med.uni-rostock.de
- Site Name
- Muenchen Klinik gGmbH
- Department Name
- Klinik für Hämatologie und Onkologie
- Principal Investigator Name
- Clemens-Martin Wendtner
- Principal Investigator Email
- clemens.wendtner@muenchen-klinik.de
- Contact Person Name
- Clemens-Martin Wendtner
- Contact Person Email
- clemens.wendtner@muenchen-klinik.de
- Site Name
- Haematologisch Onkologische Schwerpunktpraxis
- Department Name
- Gemeinschaftspraxis Dres. Schöttker & Pretscher
- Principal Investigator Name
- Bjoern Schoettker
- Principal Investigator Email
- b.schoettker@onkopraxis-wuerzburg.de
- Contact Person Name
- Bjoern Schoettker
- Contact Person Email
- b.schoettker@onkopraxis-wuerzburg.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
- Principal Investigator Name
- Carmen Herling
- Principal Investigator Email
- Carmen.Herling@medizin.uni-leipzig.de
- Contact Person Name
- Carmen Herling
- Contact Person Email
- Carmen.Herling@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation
- Principal Investigator Name
- Julia von Tresckow
- Principal Investigator Email
- Julia.vonTresckow@uk-essen.de
- Contact Person Name
- Julia von Tresckow
- Contact Person Email
- Julia.vonTresckow@uk-essen.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 4
- Number Of Participants
- 36
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 1st Dep. of Medicine - Dep. of Hematology
- Principal Investigator Name
- Marek Trněný
- Principal Investigator Email
- trneny@cesnet.cz
- Contact Person Name
- Marek Trněný
- Contact Person Email
- trneny@cesnet.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- 4th Department of Internal Medicine – Haematology
- Principal Investigator Name
- Martin Šimkovič
- Principal Investigator Email
- martin.simkovic@fnhk.cz
- Contact Person Name
- Martin Šimkovič
- Contact Person Email
- martin.simkovic@fnhk.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Internal Hematology Clinic
- Principal Investigator Name
- Heidi Móciková
- Principal Investigator Email
- heidi.mocikova@fnkv.cz
- Contact Person Name
- Heidi Móciková
- Contact Person Email
- heidi.mocikova@fnkv.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Internal hematology and oncology clinic
- Principal Investigator Name
- Anna Panovská
- Principal Investigator Email
- panovska.anna@fnbrno.cz
- Contact Person Name
- Anna Panovská
- Contact Person Email
- panovska.anna@fnbrno.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 14
- Number Of Sites
- 14
- Number Of Participants
- 38
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematologia
- Principal Investigator Name
- Rafael Andreu Lapiedra
- Principal Investigator Email
- andreu_raflap@gva.es
- Contact Person Name
- Rafael Andreu Lapiedra
- Contact Person Email
- andreu_raflap@gva.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- oncology
- Principal Investigator Name
- Sergio Ramos
- Principal Investigator Email
- sergio.ramos@startmadrid.com
- Contact Person Name
- Sergio Ramos
- Contact Person Email
- sergio.ramos@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematologia
- Principal Investigator Name
- Francesc Bosch Albareda
- Principal Investigator Email
- fbosch@vhebron.net
- Contact Person Name
- Francesc Bosch Albareda
- Contact Person Email
- fbosch@vhebron.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- hematologia
- Principal Investigator Name
- Pablo Javier Mozas Fernández
- Principal Investigator Email
- MOZAS@clinic.cat
- Contact Person Name
- Pablo Javier Mozas Fernández
- Contact Person Email
- MOZAS@clinic.cat
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Hematologia
- Principal Investigator Name
- Maria Isabel Gomez Roncero
- Principal Investigator Email
- mgroncero@telefonica.net
- Contact Person Name
- Maria Isabel Gomez Roncero
- Contact Person Email
- mgroncero@telefonica.net
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- hematologia
- Principal Investigator Name
- Angel Ramirez Payer
- Principal Investigator Email
- apayer.angel@gmail.com
- Contact Person Name
- Angel Ramirez Payer
- Contact Person Email
- apayer.angel@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Hematologia
- Principal Investigator Name
- Jose Antonio Garcia Vela
- Principal Investigator Email
- garciavela.joseantonio@gmail.com
- Contact Person Name
- Jose Antonio Garcia Vela
- Contact Person Email
- garciavela.joseantonio@gmail.com
- Site Name
- MD Anderson Cancer Center
- Department Name
- oncologia-hematologia
- Principal Investigator Name
- Adolfo De la Fuente Burguera
- Principal Investigator Email
- afuente@mdanderson.es
- Contact Person Name
- Adolfo De la Fuente Burguera
- Contact Person Email
- afuente@mdanderson.es
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- oncologia
- Principal Investigator Name
- Javier Loscertales Pueyo
- Principal Investigator Email
- jloscertales@gmail.com
- Contact Person Name
- Javier Loscertales Pueyo
- Contact Person Email
- jloscertales@gmail.com
- Site Name
- Hospital Costa Del Sol
- Department Name
- Hematologia
- Principal Investigator Name
- Maria Angeles Medina Perez
- Principal Investigator Email
- amedinaperez@gmail.com
- Contact Person Name
- Maria Angeles Medina Perez
- Contact Person Email
- amedinaperez@gmail.com
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- hematologia y hematoterapia
- Principal Investigator Name
- JOSE ANGEL HERNANDEZ RIVAS
- Principal Investigator Email
- jahernandezr@salud.madrid.org
- Contact Person Name
- JOSE ANGEL HERNANDEZ RIVAS
- Contact Person Email
- jahernandezr@salud.madrid.org
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematologia
- Principal Investigator Name
- Carmen Martinez Chamorro
- Principal Investigator Email
- carmenmartinezchamorro@hotmail.com
- Contact Person Name
- Carmen Martinez Chamorro
- Contact Person Email
- carmenmartinezchamorro@hotmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- hematologia y hematoterapia
- Principal Investigator Name
- Alicia Rodriguez Fernandez
- Principal Investigator Email
- alicia.rodriguez.fernandez.sspa@juntadeandalucia.es
- Contact Person Name
- Alicia Rodriguez Fernandez
- Contact Person Email
- alicia.rodriguez.fernandez.sspa@juntadeandalucia.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Unidad de ensayos clinicos
- Principal Investigator Name
- Fatima de la Cruz Vicente
- Principal Investigator Email
- fatimadelacruzv@gmail.com
- Contact Person Name
- Fatima de la Cruz Vicente
- Contact Person Email
- fatimadelacruzv@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 14
- Number Of Sites
- 14
- Number Of Participants
- 48
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Hématologie
- Principal Investigator Name
- Luc-Matthieu FORNECKER
- Principal Investigator Email
- Luc-matthieu.fornecker@chru-strasbourg.fr
- Contact Person Name
- Luc-Matthieu FORNECKER
- Contact Person Email
- Luc-matthieu.fornecker@chru-strasbourg.fr
- Site Name
- Centre Henri Becquerel
- Department Name
- Hématologie
- Principal Investigator Name
- Stéphane LEPRETRE
- Principal Investigator Email
- stephane.lepretre@chb.unicancer.fr
- Contact Person Name
- Stéphane LEPRETRE
- Contact Person Email
- stephane.lepretre@chb.unicancer.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Hématologie
- Principal Investigator Name
- Natalia DMYTRUK
- Principal Investigator Email
- nataliya.dmytuk@chu-limoges.fr
- Contact Person Name
- Natalia DMYTRUK
- Contact Person Email
- nataliya.dmytuk@chu-limoges.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Hématologie
- Principal Investigator Name
- Loic YSEBAERT
- Principal Investigator Email
- ysebaert.loic@iuct-oncopole.fr
- Contact Person Name
- Loic YSEBAERT
- Contact Person Email
- ysebaert.loic@iuct-oncopole.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Hématologie - Oncologie
- Principal Investigator Name
- Catherine THIEBLEMONT
- Principal Investigator Email
- catherine.thieblemont@aphp.fr
- Contact Person Name
- Catherine THIEBLEMONT
- Contact Person Email
- catherine.thieblemont@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Hématologie
- Principal Investigator Name
- Cécile TOMOWIAK
- Principal Investigator Email
- cecile.tomowiak@chu-poitiers.fr
- Contact Person Name
- Cécile TOMOWIAK
- Contact Person Email
- cecile.tomowiak@chu-poitiers.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Hématologie option maladies du sang
- Principal Investigator Name
- Emmanuelle FERRANT
- Principal Investigator Email
- emmanuelle.ferrant2@chu-lyon.fr
- Contact Person Name
- Emmanuelle FERRANT
- Contact Person Email
- emmanuelle.ferrant2@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hématologie Option Maladies du sang
- Principal Investigator Name
- Emmanuelle TCHERNONOG
- Principal Investigator Email
- e-tchernonog@chu-montpellier.fr
- Contact Person Name
- Emmanuelle TCHERNONOG
- Contact Person Email
- e-tchernonog@chu-montpellier.fr
- Site Name
- CHRU De Nancy
- Department Name
- Médecine Interne
- Principal Investigator Name
- Pierre FEUGIER
- Principal Investigator Email
- p.feugier@chru-nancy.fr
- Contact Person Name
- Pierre FEUGIER
- Contact Person Email
- p.feugier@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Tours
- Department Name
- Hématologie
- Principal Investigator Name
- Caroline DARTIGEAS
- Principal Investigator Email
- c.dartigeas@chu-tours.fr
- Contact Person Name
- Caroline DARTIGEAS
- Contact Person Email
- c.dartigeas@chu-tours.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hématologie option maladies du sang
- Principal Investigator Name
- Damien ROOS-WEIL
- Principal Investigator Email
- damien.roosweil@aphp.fr
- Contact Person Name
- Damien ROOS-WEIL
- Contact Person Email
- damien.roosweil@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hématologie option oncohématologie
- Principal Investigator Name
- Anne LOK
- Principal Investigator Email
- anne.lok@chu-nantes.fr
- Contact Person Name
- Anne LOK
- Contact Person Email
- anne.lok@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hématologie
- Principal Investigator Name
- Sophie DE GUIBERT
- Principal Investigator Email
- sophie.de.guibert@chu-rennes.fr
- Contact Person Name
- Sophie DE GUIBERT
- Contact Person Email
- sophie.de.guibert@chu-rennes.fr
- Site Name
- Clinique Victor Hugo
- Department Name
- Biologie médicale
- Principal Investigator Name
- Kamel LARIBI
- Principal Investigator Email
- klaribi@ch-lemans.fr
- Contact Person Name
- Kamel LARIBI
- Contact Person Email
- klaribi@ch-lemans.fr
Sponsor
Primary sponsor
- Full Name
- Loxo Oncology Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- IVRS – treatment randomisation; various operational roles (multiple sponsorDuties codes)
- Name
- Perceptive Eclinical Limited
- Responsibilities
- Medical Imaging Analysis
- Name
- Eresearchtechnology Inc.
- Responsibilities
- eCOA, ePRO compliance, eCOA data collection
Third parties
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Correlative studies & storage (bone marrow biopsy and aspirate, optional saliva DNA, MRD, cfDNA, PBM)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term Sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Medical Imaging Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient travel assistance","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eli Lilly & Co.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA, ePRO compliance, eCOA data collection","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Neogenomics Inc.","duties_or_roles":"Deletion 17p Kit (FISH), IGHV, Bone Marrow","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"IVRS – treatment randomisation","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- PIRTOBRUTINIB
- Active Substance
- PIRTOBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 200 mg
- Investigational Product Name
- VENETOCLAX
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 400 mg
- Investigational Product Name
- RITUXIMAB
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 500 mg/m2
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- PIRTOBRUTINIB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma
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- BGB-16673 for Chronic lymphocytic leukemia | Small lymphocytic lymphoma
- RITUXIMAB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma
- LISAFTOCLAX for Chronic lymphocytic leukemia | Small lymphocytic lymphoma