Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
334
Countries
6
Sites
16
Non-Hodgkin Lymphoid Malignancies
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 May 2024 → ongoing
- Decision date (initial)
- 2024-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Hodgkin Lymphoid Malignancies
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 36 | 2 |
| France | Ended | 4 | 2 |
| Germany | Not authorised | 6 | 3 |
| Italy | Authorised, recruitment pending | 6 | 3 |
| Netherlands | Ongoing, recruitment ended | 25 | 2 |
| Spain | Ongoing, recruitment ended | 26 | 4 |
| Rest of world
Korea, Republic of, Australia, United Kingdom, United States, Canada
|
— | 231 | — |
Investigational sites
Odense University Hospital
Haematological Research unit HFE-X OUH, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of Haematology and Phase 1 Unit, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology Department, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Nantes
Hematology Department, 1 Place Alexis Ricordeau, 44000, Nantes
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Med. Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II des Universitaetsklinikums Zentrum Innere Medizin (ZIM), Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Humanitas Mirasole S.p.A.
UOC ONCOEMATOLOGIA, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Struttura Complessa a Direzione Universitaria di Ematologia, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Hematology, Via Pietro Albertoni 15, 40138, Bologna
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Utrecht
Department of Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
Hematology Department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-05-29 | 2024-06-03 | 2026-04-28 | ||
| Netherlands | 2024-06-21 | 2024-07-05 | 2026-04-28 | ||
| Spain | 2024-07-10 | 2024-10-02 | 2026-04-28 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-16 | Denmark | Acceptable 2024-04-29
|
2024-04-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-17 | Denmark | Acceptable 2024-04-29
|
2024-05-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Acceptable | 2024-08-06 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-01 | Acceptable | 2024-08-08 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-04 | Acceptable | 2024-09-19 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-12 | Acceptable | 2024-12-05 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-26 | Denmark | Acceptable 2025-05-26
|
2025-05-27 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-23 | Denmark | Acceptable 2025-10-07
|
2025-10-07 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-10-28 | Acceptable 2025-10-07
|
2026-01-20 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-29 | Acceptable | 2025-11-05 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-10 | Denmark | Acceptable 2026-05-04
|
2026-05-05 |