Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
33
Countries
3
Sites
9
Patients with relapsed/refractory acute myeloid leukemia or myelodysplastic neoplasms
Key facts
- Sponsor
- Byondis B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 24 May 2024 → 30 Sep 2025
- Decision date (initial)
- 2024-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with relapsed/refractory acute myeloid leukemia or myelodysplastic neoplasms
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
| 21.1 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Byondis B.V.
- Sponsor organisation
- Byondis B.V.
- Address
- Microweg 22
- City
- Nijmegen
- Postcode
- 6545 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- Byondis B.V.
- Contact name
- Clinical Development
Public contact point
- Organisation
- Byondis B.V.
- Contact name
- Clinical Development
Locations
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 8 | 2 |
| Netherlands | Ended | 4 | 1 |
| Spain | Ended | 21 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Het Ziekenhuisnetwerk Antwerpen
Hematology, Kempenstraat 100, 2030, Antwerp
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Institut Catala D'oncologia
Servicio de Hematología, Carretera Canyet S/n, 08916, Badalona
Hospital De La Santa Creu I Sant Pau
Servicio de Hematología, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario De Salamanca
Servicio de Hematología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Y Politecnico La Fe
Servicio de Hematología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Servicio de Hematología, Calle Villarroel 170, 08036, Barcelona
Hospital San Pedro De Alcantara
Servicio de Hematología, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
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 |
|---|---|---|---|---|---|
| Belgium | 2024-06-13 | 2024-07-29 | 2024-12-17 | ||
| Netherlands | 2024-06-10 | 2024-09-20 | 2025-08-20 | ||
| Spain | 2024-05-24 | 2024-06-17 | 2025-09-22 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-22 | Spain | Acceptable 2024-04-29
|
2024-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-23 | Spain | Acceptable 2025-09-16
|
2025-09-17 |