Clinical trial • Phase I/II • Oncology
Loncastuximab tesirine for Relapsed or refractory B-cell non-Hodgkin lymphoma
Phase I/II trial of Loncastuximab tesirine for Relapsed or refractory B-cell non-Hodgkin lymphoma. open-label. 73 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory B-cell non-Hodgkin lymphoma
- Trial Stage
- Phase I/II
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 29-02-2024
- First CTIS Authorization Date
- 09-04-2024
Trial design
open-label Phase I/II trial across 16 sites in Czechia, Spain, Italy and others.
- Open Label
- Yes
- Target Sample Size
- 73
Recruitment
- Planned Sample Size
- 73
- Recruitment Window Months
- 64
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 121
Czechia
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 707
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Onkologická klinika 2. LF UK a FN Motol
- Contact Person Name
- Kateřina Kopečková
- Contact Person Email
- katerina.kopeckova@fnmotol.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Hematologická klinika
- Contact Person Name
- Heidi Móciková
- Contact Person Email
- heidi.mocikova@seznam.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Contact Person Name
- Juraj Ďuraš
- Contact Person Email
- juraj.duras@fno.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní hematologická a onkologická klinika
- Contact Person Name
- Jiří Mayer
- Contact Person Email
- mayer.jiri@fnbrno.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 712
- Number Of Sites
- 6
- Number Of Participants
- 41
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Lymphoma Unit
- Contact Person Name
- Eva Maria Gonzalez Barca
- Contact Person Email
- e.gonzalez@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology Department
- Contact Person Name
- Javier Lopez Jimenez
- Contact Person Email
- jljimenez@salud.madrid.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology Department
- Contact Person Name
- Juana Clavel Pia
- Contact Person Email
- clavel_jua@gva.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology Department
- Contact Person Name
- Alejandro Martín García Sancho
- Contact Person Email
- amartingar@usal.es
- Site Name
- Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
- Department Name
- Hematology Department
- Contact Person Name
- Mariana Bastos-Oreiro
- Contact Person Email
- bastosmariana@yahoo.com
Italy
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 707
- Number Of Sites
- 4
- Number Of Participants
- 35
Sites
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Unità di Oncoematologia
- Contact Person Name
- Enrico Derenzini
- Contact Person Email
- enrico.derenzini@ieo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O.C. Ematologia
- Contact Person Name
- Alessandra Tucci
- Contact Person Email
- alessandra.tucci@asst-spedalicivili.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Unità linfomi e sindromi linfoproliferative croniche -
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- SC Ematologia
- Contact Person Name
- Silvia Ferrari
- Contact Person Email
- s.ferrari@asst-pg23.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 707
- Number Of Sites
- 2
- Number Of Participants
- 22
Sites
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Contact Person Name
- Gilles Crochet
- Contact Person Email
- Gilles.crochet@chuuclnamur.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Contact Person Name
- Fritz Offner
- Contact Person Email
- fritz.offner@uzgent.be
Sponsor
Primary sponsor
- Full Name
- ADC Therapeutics SA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Loncastuximab tesirine
- Active Substance
- Loncastuximab tesirine
- Modality
- ADC
- Combination Treatment
- Yes
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