Clinical trial • Phase I/II • Oncology

JNJ-90014496 for B-cell non-Hodgkin lymphoma | Non-Hodgkin lymphoma

Phase I/II trial of JNJ-90014496 for B-cell non-Hodgkin lymphoma | Non-Hodgkin lymphoma. 231 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
B-cell non-Hodgkin lymphoma | Non-Hodgkin lymphoma
Trial Stage
Phase I/II

Key dates

Initial CTIS Submission Date
16-01-2024
First CTIS Authorization Date
30-04-2024

Trial design

Phase I/II trial across 16 sites in Germany, France, Denmark and others.

Target Sample Size
231
Trial Duration For Participant
1645

Recruitment

Planned Sample Size
231
Recruitment Window Months
54

Geography

Total Number Of Sites
16
Total Number Of Participants
103

Germany

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
06-05-2024
Processing Time Days
17
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Med. Klinik und Poliklinik
Contact Person Name
Georg Hess
Contact Person Email
georg.hess@unimedizin-mainz.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Contact Person Name
Bastian von Tresckow
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II des Universitaetsklinikums Zentrum Innere Medizin (ZIM)
Contact Person Name
Max Topp
Contact Person Email
topp_m@ukw.de

France

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
27-05-2025
Processing Time Days
446
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Hematology Department
Contact Person Name
Loic YSEBAERT
Contact Person Email
ysebaert.loic@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology Department
Contact Person Name
Benoit TESSOULIN
Contact Person Email
benoit.tessoulin@chu-nantes.fr

Denmark

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
750
Number Of Sites
2
Number Of Participants
36

Sites

Site Name
Odense University Hospital
Department Name
Haematological Research unit HFE-X OUH
Contact Person Name
Jacob Haaber Christensen
Contact Person Email
jacob.h.christensen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Haematology and Phase 1 Unit
Contact Person Name
Martin Hutchings
Contact Person Email
martin.hutchings@regionh.dk

Italy

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
196
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
UOC ONCOEMATOLOGIA
Contact Person Name
Stefania Bramanti
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Hematology
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
Struttura Complessa a Direzione Universitaria di Ematologia
Contact Person Name
Marco Ladetto
Contact Person Email
marco.ladetto@ospedale.al.it

Spain

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
745
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Pere Barba
Contact Person Email
pbarba@vhio.net
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Contact Person Name
Pablo Mozas
Contact Person Email
mozas@clinic.cat
Site Name
Institut Catala D'oncologia
Department Name
Hematology Department
Contact Person Name
Anna Maria Sureda
Contact Person Email
asureda@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Daniel Morillo
Contact Person Email
dmorillo@startmadrid.com

Netherlands

Earliest CTIS Part Ii Submission Date
24-04-2024
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
742
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Department of Hematology
Contact Person Name
Yasmina Serroukh
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Department of Hematology
Contact Person Name
Margot Jak
Contact Person Email
hemat-research@umcutrecht.nl

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
JNJ-90014496

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