Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
94
Countries
4
Sites
12
Myeloid disease
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Dec 2023 → ongoing
- Decision date (initial)
- 2023-03-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501406-36-00
- ClinicalTrials.gov
- NCT05552469
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myeloid disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028548 | Myeloid dysplasia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 8 | 4 |
| Germany | Ongoing, recruitment ended | 9 | 4 |
| Italy | Ended | 12 | 2 |
| Spain | Ongoing, recruitment ended | 10 | 2 |
| Rest of world
United States, Hong Kong, United Kingdom, Singapore
|
— | 55 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
6001: Hematology, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Centre Hospitalier Universitaire De Nantes
6000: Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Hopital Saint Louis
6002:Hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli Calmettes
6003:Hematology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Universitaetsklinikum Schleswig-Holstein AöR
9004:Klinik Haematologie und Onkologie Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck
Universitaetsklinikum Duesseldorf AöR
9003:Klinik für Hämatologie, Onkologie und klinische Immunologie, Moorenstrasse 5, Bilk, Duesseldorf
University of Leipzig
9000: Medical Department for Haematology, Cell Therapy and Hemostaseology, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Technische Universitat Dresden
9001: Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
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 | 2024-03-12 | 2024-03-12 | 2025-12-19 | ||
| Germany | 2024-01-18 | 2024-01-18 | 2025-12-02 | ||
| Italy | 2023-12-14 | 2023-12-14 | 2024-03-26 | ||
| Spain | 2023-12-29 | 2023-12-29 | 2025-11-04 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-23 | Germany | Acceptable 2023-03-27
|
2023-03-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-16 | Germany | Acceptable 2023-11-03
|
2023-11-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-12 | Germany | Acceptable 2024-02-26
|
2024-02-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-11 | Germany | Acceptable | 2024-11-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-13 | Germany | Acceptable | 2024-12-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-22 | Germany | Acceptable 2025-03-18
|
2025-03-18 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-14 | Germany | Acceptable 2025-07-23
|
2025-07-23 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-26 | Germany | Acceptable | 2025-10-21 |