Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
116
Countries
1
Sites
1
Newly Diagnosed Acute Myeloid Leukemia with an IDH1 and/or IDH2 Mutation
Key facts
- Sponsor
- Institut De Recherches Internationales Servier IRIS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 16 Dec 2015 → ongoing
- Decision date (initial)
- 2024-09-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511380-29-00
- EudraCT number
- 2015-004290-33
- ClinicalTrials.gov
- NCT02632708
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Newly Diagnosed Acute Myeloid Leukemia with an IDH1 and/or IDH2 Mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028557 | Myeloid leukemia acute | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recherches Internationales Servier IRIS
- Sponsor organisation
- Institut De Recherches Internationales Servier IRIS
- Address
- 22 Route 128
- City
- Gif Sur Yvette
- Postcode
- 91190
- Country
- France
Scientific contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Public contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 2 | 1 |
| Rest of world
United States
|
— | 114 | — |
Investigational sites
Stichting Amsterdam UMC
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2015-12-16 | 2016-01-06 | 2018-07-24 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Netherlands | Acceptable with conditions 2024-09-23
|
2024-09-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Netherlands | Acceptable 2025-03-03
|
2025-03-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-30 | Netherlands | Acceptable 2025-03-03
|
2025-04-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-16 | Netherlands | Acceptable 2025-03-03
|
2025-10-16 |