Clinical trial • Phase III • Oncology
POLATUZUMAB VEDOTIN for Diffuse large B-cell lymphoma (DLBCL)
Phase III trial of POLATUZUMAB VEDOTIN for Diffuse large B-cell lymphoma (DLBCL).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Diffuse large B-cell lymphoma (DLBCL)
- Trial Stage
- Phase III
- Drug Modality
- ADC|Monoclonal antibody|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 27-09-2024
- First CTIS Authorization Date
- 04-11-2024
Trial design
Randomised, arm b (control): rituximab plus chop (rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone). arm a (experimental): polatuzumab vedotin in combination with rituximab and chp (rituximab + cyclophosphamide + doxorubicin + prednisone) — i.e., polatuzumab + r-chp versus r-chop. specific per-arm doses/schedules are not specified in the available ctis part i/ii summary (product entries include maximum dose amounts per product but no regimen schedule). Phase III trial in Belgium, Czechia, Germany and others.
- Randomised
- Yes
- Comparator
- Arm B (Control): Rituximab plus CHOP (rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone). Arm A (Experimental): Polatuzumab vedotin in combination with rituximab and CHP (rituximab + cyclophosphamide + doxorubicin + prednisone) — i.e., Polatuzumab + R-CHP versus R-CHOP. Specific per-arm doses/schedules are not specified in the available CTIS Part I/II summary (product entries include maximum dose amounts per product but no regimen schedule).
- Target Sample Size
- 644
Eligibility
Recruits 644 Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms are provided in multiple versions and languages. Documents in the record include 'Pregnant Partner Authorization' forms and a document titled 'Witness CaregiverHealthy volunteerLegal representative Data protection', indicating provisions for consent involving pregnant partners, witnesses/caregivers or legal representatives. Specific assent processes for minors are not detailed in the available documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms are provided in multiple versions and languages. Documents in the record include 'Pregnant Partner Authorization' forms and a document titled 'Witness CaregiverHealthy volunteerLegal representative Data protection', indicating provisions for consent involving pregnant partners, witnesses/caregivers or legal representatives. Specific assent processes for minors are not detailed in the available documents.
Inclusion criteria
- {"criterion_text":"- Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms: – DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type – T-cell/histiocyte-rich large B-cell lymphoma – Epstein-Barr virus-positive DLBCL, NOS – ALK-positive large B-cell lymphoma – HHV8-positive DLBCL, NOS – High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma) – High-grade B-cell lymphoma, NOS\n- International Prognostic Index (IPI) score of 2-5\n- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n- Life expectancy ≥ 12 months\n- At least one bi-dimensionally measurable lesion, defined as >1.5 cm in its longest dimension as measured by computed tomography (CT) or magnetic resonance imaging (MRI)\n- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)"}
Exclusion criteria
- {"criterion_text":"- Prior organ transplantation\n- Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n- History of indolent lymphoma\n- Prior treatment with cytotoxic drugs within 5 years of screening for any condition (e.g., cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody\n- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1; any investigational therapy within 28 days prior to the start of Cycle 1; vaccination with live vaccines within 28 days prior the start of Cycle 1\n- Prior radiotherapy to the mediastinal/pericardial region"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Progression-free survival, defined as the time from randomization to the first occurrence of disease progression or relapse as assessed by the investigator by using the Lugano Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurs earlier","definition_or_measurement_approach":"Progression-free survival (PFS): time from randomization to first occurrence of disease progression or relapse or death, assessed by investigator using the Lugano Response Criteria for Malignant Lymphoma."}
Secondary endpoints
- {"endpoint_text":"- 1. Event-free survival (efficacy) as determined by the investigator\n- 2. Complete response rate at end of treatment by fluorodeoxyglucose positron emission tomography (FDG-PET) as determined by blinded independent central review (BICR)\n- 3. Overall Survival (OS)\n- 4. CR rate at end of treatmentby FDG-PET as determined by the investigator\n- 5. 2-year progression-free survival rate (PFS24) as determined by the investigator\n- 6. Disease-free survival (DFS)\n- 7. Duration of response (DOR)\n- 8. Event-free survival (all causes)\n- 9. Time to deterioration in european organisation for research and treatment of cancer quality of life-core 30 questionnaire (EORTC QLQ-C30) physical functioning and fatigue and functional assessment of cancer therapy-lymphoma lymphoma subscale (FACT-Lym LymS)\n- 10. Proportion of patients achieving meaningful improvement in EORTC QLQ-C30 physical functioning and fatigue, and FACT-Lym LymS\n- 11. EORTC QLQ-C30 rate of treatment-related symptoms and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity (FACT/GOG-NTX) peripheral neuropathy rate\n- 12. Incidence, nature, and severity of adverse events, with severity determined through use of national cancer institute common terminology criteria for adverse events, version 4.0 (NCI CTCAE v4.0)\n- 13. Incidence of peripheral neuropathy rates and severity determined through use of NCI CTCAE v4.0\n- 14. Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to adverse events\n- 15. Dose intensities of study drugs\n- 16. Plasma and/or serum concentration of polatuzumab vedotin related analytes at specified time points\n- 17. Incidence of anti-drug antibodies (ADAs) to polatuzumab vedotin during the study relative to the prevalence of ADAs to polatuzumab vedotin at baseline","definition_or_measurement_approach":"- Event-free survival (efficacy): determined by investigator\n- Complete response rate at end of treatment by FDG-PET: determined by blinded independent central review (BICR)\n- Overall Survival (OS): time to death from any cause\n- CR rate at end of treatment by FDG-PET (investigator): investigator-assessed FDG-PET\n- 2-year PFS rate (PFS24): investigator-determined PFS at 2 years\n- Disease-free survival (DFS): time to disease recurrence\n- Duration of response (DOR): time from response to progression\n- Event-free survival (all causes): event-free survival considering all-cause events\n- Time to deterioration in EORTC QLQ-C30 physical functioning and fatigue and FACT-Lym LymS: measured using EORTC QLQ-C30 and FACT-Lym LymS questionnaires\n- Proportion achieving meaningful improvement in EORTC QLQ-C30 and FACT-Lym LymS: questionnaire-based responder analyses\n- EORTC QLQ-C30 treatment-related symptoms and FACT/GOG-NTX peripheral neuropathy rate: patient-reported outcomes and FACT/GOG-NTX instrument\n- Incidence, nature, severity of AEs: graded per NCI CTCAE v4.0\n- Peripheral neuropathy incidence/severity: NCI CTCAE v4.0\n- Incidence and nature of study drug discontinuation/dose reduction/delay: study drug exposure records and AE attribution\n- Dose intensities: recorded dose intensity calculations\n- Plasma/serum concentrations of polatuzumab vedotin analytes: PK sampling at specified time points\n- Incidence of anti-drug antibodies (ADAs): immunogenicity testing during study relative to baseline"}
Recruitment
- Planned Sample Size
- 644
- Recruitment Window Months
- 103
- Consent Approach
- Subject information sheets and informed consent forms are available (multiple versions). Documents include 'Main' ICFs and additional ICFs for 'Pregnant Partner', 'Optional samples', 'Privacy' and locally translated versions. Multiple language versions are provided (examples in the document list include EN, FR, ES, DE, IT, PL, CZ, NL and others). A document title references 'Witness CaregiverHealthy volunteerLegal representative', and separate 'Pregnant Partner Authorization' documents are present, indicating provisions for pregnant partners and for use of witnesses/caregivers/legal representatives where applicable. Consent is obtained via the provided ICFs; specific age-related assent procedures are not detailed in the available record.
Geography
- Total Number Of Sites
- 77
- Total Number Of Participants
- 356
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 515
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Principal Investigator Name
- Ciel DE VRIENDT
- Principal Investigator Email
- ciel.devriendt@uzgent.be
- Contact Person Name
- Ciel DE VRIENDT
- Contact Person Email
- ciel.devriendt@uzgent.be
- Site Name
- CHU Helora
- Department Name
- Hematology
- Principal Investigator Name
- Marie-Christine NGIRABACU
- Principal Investigator Email
- mariechristine.ngirabacu@jolimont.be
- Contact Person Name
- Marie-Christine NGIRABACU
- Contact Person Email
- mariechristine.ngirabacu@jolimont.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Principal Investigator Name
- Marc ANDRE
- Principal Investigator Email
- marc.andre@chuuclnamur.uclouvain.be
- Contact Person Name
- Marc ANDRE
- Contact Person Email
- marc.andre@chuuclnamur.uclouvain.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 518
- Number Of Sites
- 5
- Number Of Participants
- 38
Sites
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Heamatology
- Principal Investigator Name
- Heidi Mocikova
- Principal Investigator Email
- heidi.mocikova@fnkv.cz
- Contact Person Name
- Heidi Mocikova
- Contact Person Email
- heidi.mocikova@fnkv.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Haematological Clinic
- Principal Investigator Name
- Marek Trněný
- Principal Investigator Email
- marek.trneny@vfn.cz
- Contact Person Name
- Marek Trněný
- Contact Person Email
- marek.trneny@vfn.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Hemato-oncology clinic
- Principal Investigator Name
- Vit Procházka
- Principal Investigator Email
- Vit.Prochazka@fnol.cz
- Contact Person Name
- Vit Procházka
- Contact Person Email
- Vit.Prochazka@fnol.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Department of Clinical Hemato-Oncology
- Principal Investigator Name
- Roman Hájek
- Principal Investigator Email
- roman.hajek@fno.cz
- Contact Person Name
- Roman Hájek
- Contact Person Email
- roman.hajek@fno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Department of Internal Medicine - Haematology
- Principal Investigator Name
- David Belada
- Principal Investigator Email
- david.belada@fnhk.cz
- Contact Person Name
- David Belada
- Contact Person Email
- david.belada@fnhk.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 518
- Number Of Sites
- 8
- Number Of Participants
- 7
Sites
- Site Name
- Institut Fuer Versorgungsforschung In Der Onkologie GbR
- Department Name
- Praxisklinik für Hämatologie und Onkologie Koblenz
- Principal Investigator Name
- Rudolf Weide
- Principal Investigator Email
- weide@invo-koblenz.de
- Contact Person Name
- Rudolf Weide
- Contact Person Email
- weide@invo-koblenz.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Hämatologie und Onkologie
- Principal Investigator Name
- Christian Scholz
- Principal Investigator Email
- christianw.scholz@vivantes.de
- Contact Person Name
- Christian Scholz
- Contact Person Email
- christianw.scholz@vivantes.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Hämatologie
- Principal Investigator Name
- Andreas Huettmann
- Principal Investigator Email
- Andreas.Huettmann@uk-essen.de
- Contact Person Name
- Andreas Huettmann
- Contact Person Email
- Andreas.Huettmann@uk-essen.de
- Site Name
- Staedtisches Klinikum Dessau
- Department Name
- Klinik für Innere Medizin-Hämatologie/Onkologie
- Principal Investigator Name
- Inessa Paulenz
- Principal Investigator Email
- inessa.nelk@klinikum-dessau.de
- Contact Person Name
- Inessa Paulenz
- Contact Person Email
- inessa.nelk@klinikum-dessau.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Medizinische Klinik A
- Principal Investigator Name
- Georg Lenz
- Principal Investigator Email
- georg.lenz@ukmuenster.de
- Contact Person Name
- Georg Lenz
- Contact Person Email
- georg.lenz@ukmuenster.de
- Site Name
- Universitaetsklinikum Halle (Saale) AöR
- Department Name
- Universitätsklinik und Poliklinik für Innere Medizin IV
- Principal Investigator Name
- Thomas Weber
- Principal Investigator Email
- thomas.weber@uk-halle.de
- Contact Person Name
- Thomas Weber
- Contact Person Email
- thomas.weber@uk-halle.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Medizin V,Hämatologie,Onkologie,Rheumatologie
- Principal Investigator Name
- Isabelle Krämer
- Principal Investigator Email
- isabelle.kraemer@med.uni-heidelberg.de
- Contact Person Name
- Isabelle Krämer
- Contact Person Email
- isabelle.kraemer@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Muenster AöR (duplicate entry in list?)
- Department Name
- Medizinische Klinik A
- Principal Investigator Name
- Georg Lenz
- Principal Investigator Email
- georg.lenz@ukmuenster.de
- Contact Person Name
- Georg Lenz
- Contact Person Email
- georg.lenz@ukmuenster.de
Poland
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 518
- Number Of Sites
- 4
- Number Of Participants
- 26
Sites
- Site Name
- Uniwersytet Medyczny w Lodzi - Klinika Hematologii
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Magdalena Witkowska
- Principal Investigator Email
- magdamalicka@gmail.com
- Contact Person Name
- Magdalena Witkowska
- Contact Person Email
- magdamalicka@gmail.com
- Site Name
- SP ZOZ Ministerstwa Spraw Wewnętrznych w Poznaniu im. Prof. Ludwika Bierkowskiego
- Department Name
- Oddział Hematologii
- Principal Investigator Name
- Tomasz Woźny
- Principal Investigator Email
- twozny@szpitalmswia.poznan.pl
- Contact Person Name
- Tomasz Woźny
- Contact Person Email
- twozny@szpitalmswia.poznan.pl
- Site Name
- Pratia S.A.
- Department Name
- Pratia Małopolskie Centrum Medyczne (MCM) Kraków
- Principal Investigator Name
- Wojciech Jurczak
- Principal Investigator Email
- wjurczak.mcm@mp.pl
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- wjurczak.mcm@mp.pl
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Klinika Chorób Wewnętrznych i Hematologii
- Principal Investigator Name
- Kinga Glogowska
- Principal Investigator Email
- kglogowska@wim.mil.pl
- Contact Person Name
- Kinga Glogowska
- Contact Person Email
- kglogowska@wim.mil.pl
Austria
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 518
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Univ. Klinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
- Principal Investigator Name
- Philipp Staber
- Principal Investigator Email
- philipp.staber@meduniwien.ac.at
- Contact Person Name
- Philipp Staber
- Contact Person Email
- philipp.staber@meduniwien.ac.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Medizinische Abteilung, Zentrum für Onkologie und Hämatologie
- Principal Investigator Name
- Dora Niedersüß-Beke
- Principal Investigator Email
- dora.niedersuess-beke@wienkav.at
- Contact Person Name
- Dora Niedersüß-Beke
- Contact Person Email
- dora.niedersuess-beke@wienkav.at
- Site Name
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
- Department Name
- Universitätsklinik für Innere Medizin III
- Principal Investigator Name
- Thomas Melchardt
- Principal Investigator Email
- t.melchardt@salk.at
- Contact Person Name
- Thomas Melchardt
- Contact Person Email
- t.melchardt@salk.at
Italy
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 519
- Number Of Sites
- 9
- Number Of Participants
- 31
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Hematology
- Principal Investigator Name
- Anna Maria Barbui
- Principal Investigator Email
- abarbui@asst-pg23.it
- Contact Person Name
- Anna Maria Barbui
- Contact Person Email
- abarbui@asst-pg23.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- Hematology
- 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
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Oncologic Hematology
- Principal Investigator Name
- Antonio Pinto
- Principal Investigator Email
- a.pinto@istitutotumori.na.it
- Contact Person Name
- Antonio Pinto
- Contact Person Email
- a.pinto@istitutotumori.na.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Hematology
- Principal Investigator Name
- Chiara Ghiggi
- Principal Investigator Email
- chiara.ghiggi@hsanmartino.it
- Contact Person Name
- Chiara Ghiggi
- Contact Person Email
- chiara.ghiggi@hsanmartino.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Hematology
- 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
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Hematology
- Principal Investigator Name
- Francesco Merli
- Principal Investigator Email
- merli.francesco@ausl.re.it
- Contact Person Name
- Francesco Merli
- Contact Person Email
- merli.francesco@ausl.re.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Hematology
- Principal Investigator Name
- Barbara Botto
- Principal Investigator Email
- bbotto@cittadellasalute.to.it
- Contact Person Name
- Barbara Botto
- Contact Person Email
- bbotto@cittadellasalute.to.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Hematology
- Principal Investigator Name
- Alessandra Tucci
- Principal Investigator Email
- alessandra.tucci@asst-spedalicivili.it
- Contact Person Name
- Alessandra Tucci
- Contact Person Email
- alessandra.tucci@asst-spedalicivili.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino (duplicate entry?)
- Department Name
- Hematology
- Principal Investigator Name
- Barbara Botto
- Principal Investigator Email
- bbotto@cittadellasalute.to.it
- Contact Person Name
- Barbara Botto
- Contact Person Email
- bbotto@cittadellasalute.to.it
Spain
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 519
- Number Of Sites
- 13
- Number Of Participants
- 46
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Hematology Service
- Principal Investigator Name
- Victor Jiménez
- Principal Investigator Email
- vjyuste@gmail.com
- Contact Person Name
- Victor Jiménez
- Contact Person Email
- vjyuste@gmail.com
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- Hematology and Hemotherapy Service
- Principal Investigator Name
- Juan Miguel Bergua
- Principal Investigator Email
- jmberguaburg@gmail.com
- Contact Person Name
- Juan Miguel Bergua
- Contact Person Email
- jmberguaburg@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology Unit
- Principal Investigator Name
- Armando López-Guillermo
- Principal Investigator Email
- alopezg@clinic.cat
- Contact Person Name
- Armando López-Guillermo
- Contact Person Email
- alopezg@clinic.cat
- Site Name
- Institut Catala D'oncologia (Girona)
- Department Name
- Hematology Service
- Principal Investigator Name
- Nicholas Kelleher
- Principal Investigator Email
- nkelleher@iconcologia.net
- Contact Person Name
- Nicholas Kelleher
- Contact Person Email
- nkelleher@iconcologia.net
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Hematology Service
- Principal Investigator Name
- José María Arguiñano
- Principal Investigator Email
- jm.arguinano.perez@navarra.es
- Contact Person Name
- José María Arguiñano
- Contact Person Email
- jm.arguinano.perez@navarra.es
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematology and Hemotherapy Service
- Principal Investigator Name
- Carmen Martínez
- Principal Investigator Email
- carmenmartinezchamorro@hotmail.com
- Contact Person Name
- Carmen Martínez
- Contact Person Email
- carmenmartinezchamorro@hotmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology and Hemotherapy Service
- Principal Investigator Name
- Sergio Ramos
- Principal Investigator Email
- sergio.ramosc@quironsalud.com
- Contact Person Name
- Sergio Ramos
- Contact Person Email
- sergio.ramosc@quironsalud.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Hematology Service
- Principal Investigator Name
- Javier Briones
- Principal Investigator Email
- jbriones@santpau.cat
- Contact Person Name
- Javier Briones
- Contact Person Email
- jbriones@santpau.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology Unit
- Principal Investigator Name
- Fátima De La Cruz
- Principal Investigator Email
- fatimadelacruzv@gmail.com
- Contact Person Name
- Fátima De La Cruz
- Contact Person Email
- fatimadelacruzv@gmail.com
- Site Name
- Institut Catala D'oncologia (L'hospitalet De Llobregat)
- Department Name
- Hematology and Hemotherapy Service
- Principal Investigator Name
- Eva González
- Principal Investigator Email
- e.gonzalez@iconcologia.net
- Contact Person Name
- Eva González
- Contact Person Email
- e.gonzalez@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology and Hemotherapy Service
- Principal Investigator Name
- Pau Abrisqueta
- Principal Investigator Email
- pau.abrisqueta9@gmail.com
- Contact Person Name
- Pau Abrisqueta
- Contact Person Email
- pau.abrisqueta9@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology Service
- Principal Investigator Name
- Laura Gálvez
- Principal Investigator Email
- lauragalvezcarvajal@hotmail.com
- Contact Person Name
- Laura Gálvez
- Contact Person Email
- lauragalvezcarvajal@hotmail.com
- Site Name
- Hospital Clinic De Barcelona (duplicate entry?)
- Department Name
- Hematology and Hemotherapy Service
- Principal Investigator Name
- Pau Abrisqueta
- Principal Investigator Email
- pau.abrisqueta9@gmail.com
- Contact Person Name
- Pau Abrisqueta
- Contact Person Email
- pau.abrisqueta9@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 550
- Number Of Sites
- 32
- Number Of Participants
- 186
Sites
- Site Name
- Centre Hospitalier Bretagne Atlantique
- Department Name
- Hematology
- Principal Investigator Name
- Anne PARCELIER
- Principal Investigator Email
- anneparcelier@yahoo.fr
- Contact Person Name
- Anne PARCELIER
- Contact Person Email
- anneparcelier@yahoo.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hematology
- Principal Investigator Name
- Thomas GASTINNE
- Principal Investigator Email
- thomas.gastinne@chu-nantes.fr
- Contact Person Name
- Thomas GASTINNE
- Contact Person Email
- thomas.gastinne@chu-nantes.fr
- Site Name
- Centre Leon Berard
- Department Name
- Hematology
- Principal Investigator Name
- Emmanuelle NICOLAS VIRELIZIER
- Principal Investigator Email
- emmanuelle.nicolas-virelizier@lyon.unicancer.fr
- Contact Person Name
- Emmanuelle NICOLAS VIRELIZIER
- Contact Person Email
- emmanuelle.nicolas-virelizier@lyon.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hematology
- 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
- Institut Bergonie
- Department Name
- Hematology
- Principal Investigator Name
- Anna SCHMITT
- Principal Investigator Email
- a.schmitt@bordeaux.unicancer.fr
- Contact Person Name
- Anna SCHMITT
- Contact Person Email
- a.schmitt@bordeaux.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hematology
- Principal Investigator Name
- Guillaume CARTRON
- Principal Investigator Email
- g-cartron@chu-montpellier.fr
- Contact Person Name
- Guillaume CARTRON
- Contact Person Email
- g-cartron@chu-montpellier.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Hematology
- Principal Investigator Name
- Luc-Matthieu FORNECKER
- Principal Investigator Email
- lm.fornecker@icans.eu
- Contact Person Name
- Luc-Matthieu FORNECKER
- Contact Person Email
- lm.fornecker@icans.eu
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Hematology
- Principal Investigator Name
- Lucie OBERIC
- Principal Investigator Email
- oberic.lucie@iuct-oncopole.fr
- Contact Person Name
- Lucie OBERIC
- Contact Person Email
- oberic.lucie@iuct-oncopole.fr
- Site Name
- Centre Hospitalier De Saint-Brieuc
- Department Name
- Hematology
- Principal Investigator Name
- Maxime MARC
- Principal Investigator Email
- maxime.marc@armorsante.bzh
- Contact Person Name
- Maxime MARC
- Contact Person Email
- maxime.marc@armorsante.bzh
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hematology
- Principal Investigator Name
- Violaine SAFAR
- Principal Investigator Email
- violaine.safar@chu-lyon.fr
- Contact Person Name
- Violaine SAFAR
- Contact Person Email
- violaine.safar@chu-lyon.fr
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- Hematology
- Principal Investigator Name
- Ronan LE CALLOCH
- Principal Investigator Email
- r.lecalloch@ch-cornouaille.fr
- Contact Person Name
- Ronan LE CALLOCH
- Contact Person Email
- r.lecalloch@ch-cornouaille.fr
- Site Name
- Centre Hospitalier De Perpignan
- Department Name
- Hematology
- Principal Investigator Name
- Laurence SANHES
- Principal Investigator Email
- laurence.sanhes@ch-perpignan.fr
- Contact Person Name
- Laurence SANHES
- Contact Person Email
- laurence.sanhes@ch-perpignan.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hematology
- Principal Investigator Name
- Kamal Krimo BOUABDALLAH
- Principal Investigator Email
- krimo.bouabdallah@chu-bordeaux.fr
- Contact Person Name
- Kamal Krimo BOUABDALLAH
- Contact Person Email
- krimo.bouabdallah@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Hematology
- Principal Investigator Name
- Julie ABRAHAM
- Principal Investigator Email
- julie.abraham@chu-limoges.fr
- Contact Person Name
- Julie ABRAHAM
- Contact Person Email
- julie.abraham@chu-limoges.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hematology
- Principal Investigator Name
- Emmanuel GYAN
- Principal Investigator Email
- emmanuel.gyan@univ-tours.fr
- Contact Person Name
- Emmanuel GYAN
- Contact Person Email
- emmanuel.gyan@univ-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hematology
- Principal Investigator Name
- Thierry LAMY de la CHAPELLE
- Principal Investigator Email
- thierry.lamy.de.la.chapelle@chu-rennes.fr
- Contact Person Name
- Thierry LAMY de la CHAPELLE
- Contact Person Email
- thierry.lamy.de.la.chapelle@chu-rennes.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Hematology
- Principal Investigator Name
- Antoine LEVEQUE
- Principal Investigator Email
- antoine.leveque@ght85.fr
- Contact Person Name
- Antoine LEVEQUE
- Contact Person Email
- antoine.leveque@ght85.fr
- Site Name
- Centre Henri Becquerel
- Department Name
- Hematology
- Principal Investigator Name
- Hervé TILLY
- Principal Investigator Email
- herve.tilly@chb.unicancer.fr
- Contact Person Name
- Hervé TILLY
- Contact Person Email
- herve.tilly@chb.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Hematology
- Principal Investigator Name
- Vincent DELWAIL
- Principal Investigator Email
- v.delwail@chu-poitiers.fr
- Contact Person Name
- Vincent DELWAIL
- Contact Person Email
- v.delwail@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Hematology
- Principal Investigator Name
- Caroline SKRZYPCZAK
- Principal Investigator Email
- skrzypczak.caroline@chu-amiens.fr
- Contact Person Name
- Caroline SKRZYPCZAK
- Contact Person Email
- skrzypczak.caroline@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Hematology
- Principal Investigator Name
- Steeve CHEVREUX
- Principal Investigator Email
- steeve.chevreux@cheu-dijon.fr
- Contact Person Name
- Steeve CHEVREUX
- Contact Person Email
- steeve.chevreux@cheu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Hematology
- Principal Investigator Name
- Ludovic FOUILLET
- Principal Investigator Email
- ludovic.fouillet@chu-st-etienne.fr
- Contact Person Name
- Ludovic FOUILLET
- Contact Person Email
- ludovic.fouillet@chu-st-etienne.fr
- Site Name
- Clinique Victor Hugo
- Department Name
- Centre De Cancerologie De La Sarthe
- Principal Investigator Name
- Marielle LE GOFF
- Principal Investigator Email
- essaislegoff@i-l-c.fr
- Contact Person Name
- Marielle LE GOFF
- Contact Person Email
- essaislegoff@i-l-c.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Hematology
- Principal Investigator Name
- Agathe WAULTIER RASCALOU
- Principal Investigator Email
- agathe.waultier.rascalou@chu-nimes.fr
- Contact Person Name
- Agathe WAULTIER RASCALOU
- Contact Person Email
- agathe.waultier.rascalou@chu-nimes.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Hematology
- Principal Investigator Name
- Franck MORSCHHAUSER
- Principal Investigator Email
- franck.morschhauser@chu-lille.fr
- Contact Person Name
- Franck MORSCHHAUSER
- Contact Person Email
- franck.morschhauser@chu-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Creteil)
- Department Name
- Hematology
- Principal Investigator Name
- Corinne HAIOUN
- Principal Investigator Email
- corinne.haioun@hmn.aphp.fr
- Contact Person Name
- Corinne HAIOUN
- Contact Person Email
- corinne.haioun@hmn.aphp.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Hematology
- Principal Investigator Name
- Anne BANOS
- Principal Investigator Email
- abanos@ch-cotebasque.fr
- Contact Person Name
- Anne BANOS
- Contact Person Email
- abanos@ch-cotebasque.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Hematology
- Principal Investigator Name
- Lysiane MOLINA
- Principal Investigator Email
- lmolina@chu-grenoble.fr
- Contact Person Name
- Lysiane MOLINA
- Contact Person Email
- lmolina@chu-grenoble.fr
- Site Name
- CHU Besancon
- Department Name
- Hematology
- Principal Investigator Name
- Adrien CHAUCHET
- Principal Investigator Email
- achauchet@chu-besancon.fr
- Contact Person Name
- Adrien CHAUCHET
- Contact Person Email
- achauchet@chu-besancon.fr
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- Global CRO
- Name
- LYSARC
- Responsibilities
- Global CRO
Third parties
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"LYSARC","duties_or_roles":"Global CRO","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Nanostring Technologies Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Polivy 140 mg powder for concentrate for solution for infusion.
- Active Substance
- POLATUZUMAB VEDOTIN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/19/1388/001)
- Orphan Designation
- Yes
- Maximum Dose
- maxDailyDoseAmount 1.8 mg/kg; maxTotalDoseAmount 10.8 mg/kg
- Investigational Product Name
- MabThera 500 mg concentrate for solution for infusion
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Authorised (marketing authorisation EU/1/98/067/002)
- Maximum Dose
- maxDailyDoseAmount 375 mg/m2; maxTotalDoseAmount 3000 mg/m2
- Investigational Product Name
- VINCRISTINE
- Active Substance
- VINORELBINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Maximum Dose
- maxDailyDoseAmount 2.0 mg; maxTotalDoseAmount 12.0 mg
- Investigational Product Name
- Vincristine placebo
- Modality
- Other
- Combination Treatment
- Yes
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