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
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
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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