Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
180
Countries
1
Sites
5
Acute myeloid leukemia or myelodysplastic syndrome of high risk group, that has come back after treatment or cannot be cured or treated by any other known therapies.
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Mar 2022 → 30 Jul 2025
- Decision date (initial)
- 2023-03-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503869-34-00
- EudraCT number
- 2020-005329-95
- WHO UTN
- U1111-1260-8965
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute myeloid leukemia or myelodysplastic syndrome of high risk group, that has come back after treatment or cannot be cured or treated by any other known therapies.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
| 21.1 | LLT | 10081514 | Acute myeloid leukemia refractory | 10029104 |
| 21.0 | LLT | 10060558 | Acute myeloid leukemia recurrent | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 48 | 5 |
| Rest of world
United States
|
— | 132 | — |
Investigational sites
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
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 |
|---|---|---|---|---|---|
| Spain | 2022-03-15 | 2022-05-19 | 2025-04-11 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-09 | Spain | Acceptable 2023-03-13
|
2023-03-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-13 | Spain | Acceptable 2023-11-20
|
2023-11-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-08 | Spain | Acceptable 2024-02-26
|
2024-02-26 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-03 | Spain | Acceptable 2024-02-26
|
2024-04-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-10 | Spain | Acceptable 2024-02-26
|
2024-05-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-05 | Spain | Acceptable 2024-07-18
|
2024-07-18 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-12 | Spain | Acceptable | 2025-01-20 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-25 | Spain | Acceptable | 2025-04-25 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-06-17 | Spain | Acceptable | 2025-06-17 |