Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
45
Countries
1
Sites
20
IGHV unmutated patients with high-risk stage A CLL features.
Key facts
- Sponsor
- French Innovative Leukemia Organization
- 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
- 1 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513718-37-00
- EudraCT number
- 2018-001475-20
- ClinicalTrials.gov
- NCT03766763
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
IGHV unmutated patients with high-risk stage A CLL features.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10008993 | Chronic lymphoid leukaemia | 10029104 |
| 21.1 | LLT | 10025302 | Lymphoid leukaemia chronic | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
French Innovative Leukemia Organization
- Sponsor organisation
- French Innovative Leukemia Organization
- Address
- 2 Boulevard Tonnelle
- City
- Tours
- Postcode
- 37000
- Country
- France
Scientific contact point
- Organisation
- French Innovative Leukemia Organization
- Contact name
- Pr Vincent LEVY
Public contact point
- Organisation
- French Innovative Leukemia Organization
- Contact name
- Pr Vincent LEVY
Locations
1 EU/EEA country · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 45 | 20 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier De Versailles
hematologie, 177 Rue De Versailles, Le Chesnay, Le Chesnay Rocquencourt
Centre Hospitalier Departemental Vendee
hematologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire De Saint Etienne
hematologie, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Henri Becquerel
hematologie, 1 Rue D Amiens, 76000, Rouen
Centre Hospitalier Universitaire De Nantes
hematologie, 1 Place Alexis Ricordeau, 44000, Nantes
CHU Henri Mondor
hematologie, 51 avenue du marechal de Lattre de Tassigny, 94000, creteil
CHU Reunion site sur
hematologie, BP 350, France, Saint Pierre
Centre Hospitalier De Beziers
hematologie, Zone Dactivite Montimaran, 2 Rue Valentin Hauy, Beziers
Institut Paoli Calmettes
hematologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire Amiens Picardie
hematologie, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire D'Angers
maladie du sang, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Le Mans
hematologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Hospices Civils De Lyon
hematologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire Grenoble Alpes
hematologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
CHRU Tours Hopital Bretonneau
hematologie, 2 Tonnelle boulevard, 37000, Tours
Centre Leon Berard
hematologie, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire D Orleans
hematologie, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Hôpital Avicenne
hematologie, 125 rue de Stalingrad, 93000, Bobigny
Hopital Prive Sevigne
hematologie, 3 Rue Du Chene Germain, 35510, Cesson Sevigne
Centre Hospitalier De Perpignan
hematologie, 20 Avenue Du Languedoc, Cs 49954, Perpignan Cedex
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 | 2024-08-01 | 2024-08-01 | 2024-08-02 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | France | Acceptable 2024-07-29
|
2024-08-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-06 | France | Acceptable 2024-07-29
|
2025-03-06 |