Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
237
Countries
5
Sites
18
Acute Myeloid Leukemia and Myelodysplastic Syndromes
Key facts
- Sponsor
- Celgene Corp., Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Jan 2022 → 30 Jul 2024
- Decision date (initial)
- 2024-02-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506117-22-00
- EudraCT number
- 2021-002799-38
- WHO UTN
- U1111-1269-1461
- ClinicalTrials.gov
- NCT05168202
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia and Myelodysplastic Syndromes
| 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
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
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Locations
5 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 45 | 5 |
| Italy | Ended | 12 | 3 |
| Norway | Ended | 14 | 2 |
| Spain | Ended | 64 | 5 |
| Sweden | Ended | 18 | 3 |
| Rest of world
United Kingdom, Canada, United States, Australia
|
— | 84 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Service d'hématologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Paoli-Calmettes
Département D’Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Bordeaux
Service d’Hématologie Clinique et Thérapie Cellulaire, Avenue De Magellan, 33600, Pessac
Institut Universitaire Du Cancer Toulouse-Oncopole
Service d’hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Gustave Roussy
Institut Gustave Roussy, 114 Rue Edouard Vaillant, 94800, Villejuif
Humanitas Research Hospital
Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
ASST Grande Ospedale Metropolitano Niguarda
Oncology and Hematology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncology and Hematology, Via Piero Maroncelli 40, 47014, Meldola
Helse Bergen HF
Department of Medicine, Hematology Section, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Klinisk Forskningspost, Rikshospitalet, Sognsvannsveien 20, 0372, Oslo
Hospital De La Santa Creu I Sant Pau
Hematologia, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario De Salamanca
Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
Institut Catala D'oncologia
Hematologia, Carretera Canyet S/n, 08916, Badalona
Hospital General Universitario Gregorio Maranon
Hematologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Marques De Valdecilla
Hematologia, Avenida Valdecilla Sn, 39008, Santander
Region Skane Skanes Universitetssjukhus
Kliniska Forskningsenheten Hematologi/Entrégatan 7, 221 85 Lund, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Hematologimottagningen/Bruna Stråket 5, 413 45 Göteborg, Bla Straket 5, 413 46, Goteborg
Karolinska University Hospital
Cancer Study Unit Huddinge M62/Medicingatan 62, 141 86 Huddinge, Halsovagen, Flemingsberg, Huddinge
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 | 2022-01-05 | 2024-04-30 | 2022-01-19 | 2024-02-29 | |
| Italy | 2022-11-03 | 2024-03-26 | 2023-01-11 | 2024-02-29 | |
| Norway | 2022-05-06 | 2022-05-16 | 2024-02-29 | ||
| Spain | 2022-01-25 | 2022-02-28 | 2024-02-29 | ||
| Sweden | 2022-05-06 | 2022-08-04 | 2024-02-29 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-12 | Sweden | Acceptable 2024-02-01
|
2024-02-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-14 | Sweden | Acceptable 2024-02-01
|
2024-05-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-22 | Sweden | Acceptable 2024-08-19
|
2024-08-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-28 | Sweden | Acceptable 2024-08-19
|
2024-08-28 |