Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
220
Countries
4
Sites
12
CALR-mutated Myeloproliferative Neoplasms
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
- 30 Jul 2024 → ongoing
- Decision date (initial)
- 2024-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
CALR-mutated Myeloproliferative Neoplasms
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
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 9 | 2 |
| Germany | Ongoing, recruiting | 27 | 6 |
| Italy | Ongoing, recruiting | 7 | 2 |
| Spain | Ongoing, recruiting | 7 | 2 |
| Rest of world
Canada, United Kingdom, Israel, Japan, United States
|
— | 170 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Centre d'investigation Clinique, 1 Avenue Claude Vellefaux, 75010, Paris
Hospices Civils De Lyon
Service Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV), Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Innere Medizin III, Hämatologie und Internistische Onkologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Medizinische Hochschule Hannover
Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Heidelberg AöR
Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Rheumatologie, Innere Medizin V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Charite Universitaetsmedizin Berlin KöR
Am Campus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Hindenburgdamm 30, Lichterfelde, Berlin
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 |
|---|---|---|---|---|---|
| France | 2024-07-30 | 2024-07-30 | |||
| Germany | 2024-09-04 | 2024-09-04 | |||
| Italy | 2026-02-19 | 2026-02-19 | |||
| Spain | 2024-10-21 | 2024-10-21 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-17 | Spain | Acceptable 2024-02-16
|
2024-02-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-01 | Spain | Acceptable 2024-02-16
|
2024-03-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-11 | Acceptable 2024-02-16
|
2024-03-11 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-03-25 | Acceptable 2024-02-16
|
2024-06-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-02 | Spain | Acceptable 2024-08-26
|
2024-08-26 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-08 | Spain | Acceptable 2024-08-26
|
2024-11-08 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-17 | Spain | Acceptable 2025-04-11
|
2025-04-11 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-15 | Acceptable | 2025-06-13 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-04-17 | Acceptable 2025-04-11
|
2025-07-07 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-03 | Spain | Acceptable 2026-04-20
|
2026-04-22 |