Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
70
Countries
1
Sites
4
Relapsed or Refractory Acute Myeloid Leukemia
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
- 6 Jul 2021 → 14 Apr 2025
- Decision date (initial)
- 2022-11-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500573-13-00
- EudraCT number
- 2020-003782-20
- WHO UTN
- U1111-1258-3187
- ClinicalTrials.gov
- NCT04789655
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or Refractory Acute Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
| 20.0 | PT | 10059034 | Acute myeloid leukaemia recurrent | 100000004864 |
| 21.1 | PT | 10081513 | Acute myeloid leukaemia refractory | 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
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 22 | 4 |
| Rest of world
Canada, United States
|
— | 48 | — |
Investigational sites
Institut Paoli-Calmettes
Département d’Onco-Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Bordeaux
Service d'Hematologie Clinique et Thérapie Cellulaire, Avenue De Magellan, 33600, Pessac
Institut Gustave Roussy
Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Hopital Saint Louis
Service d’Hématologie Adultes, 1 Avenue Claude Vellefaux, 75010, Paris
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 | 2021-07-06 | 2025-02-24 | 2021-08-17 | 2024-10-28 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-21 | France | Acceptable 2022-11-10
|
2022-11-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-02-15 | France | Acceptable 2022-11-10
|
2023-02-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-17 | France | Acceptable 2023-10-09
|
2023-10-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-11 | France | Acceptable 2024-02-26
|
2024-03-04 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-05-30 | France | Acceptable 2024-02-26
|
2024-05-30 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-11-07 | France | Acceptable 2024-02-26
|
2024-11-07 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-01-16 | France | Acceptable 2024-02-26
|
2025-01-16 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-02-07 | France | Acceptable 2024-02-26
|
2025-02-07 |