Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
120
Countries
3
Sites
12
Follicular lymphoma (FL)
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505479-56-00
- ClinicalTrials.gov
- NCT05512390
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Follicular lymphoma (FL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025320 | Lymphomas non-Hodgkin's B-cell | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 4 |
| Italy | Ended | 16 | 4 |
| Spain | Ongoing, recruitment ended | 16 | 4 |
| Rest of world
United States, Canada, Australia, Israel
|
— | 76 | — |
Investigational sites
Institut Gustave Roussy
Département d’Innovations Thérapeutiques et d’essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
Pavillion 1 F Marcel Berard 3e étage Service Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Nantes
Clinical Hematology Department, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
n/a, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Humanitas Mirasole S.p.A.
Dipartimento Scienze Biomediche, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department of Hematology and Oncology, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
OUC Haematology, Via Pietro Albertoni 15, 40138, Bologna
Ospedale San Raffaele S.r.l.
Strategic Research Program on CL, Via Olgettina 60, 20132, Milan
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Fundacion Jimenez Diaz
Start Madrid-Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
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 | 2025-07-30 | 2025-09-01 | 2026-04-13 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-24 | Italy | Acceptable 2025-07-14
|
2025-07-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-25 | Italy | Acceptable 2025-07-14
|
2025-07-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-06 | Acceptable | 2025-09-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-27 | Acceptable 2026-03-13
|
2026-03-17 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-17 | Italy | Acceptable 2026-03-13
|
2026-04-17 |