Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
80
Countries
2
Sites
15
Small Lymphocytic Lymphoma
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
- 15 Oct 2024 → ongoing
- Decision date (initial)
- 2024-08-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507637-19-00
- ClinicalTrials.gov
- NCT06291220
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Lymphocytic Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 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
2 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 12 | 8 |
| Italy | Ongoing, recruitment ended | 14 | 7 |
| Rest of world
Switzerland, Israel, United States, Australia, Taiwan
|
— | 54 | — |
Investigational sites
Katholisches Klinikum Bochum gGmbH
Clinic of Hematology, Oncology and Palliative Medicine, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Innere Medizin II - Hämatologie, Onkologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Wuerzburg AöR
Medizinische Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Klinikum Chemnitz gGmbH
Internal Medicine III, Flemmingstrasse 2, Altendorf, Chemnitz
Charite Universitaetsmedizin Berlin KöR
Dept. of Hematology, Onocology and Tumorimmunology, Hindenburgdamm 30, Lichterfelde, Berlin
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Martin-Luther-Universitaet Halle-Wittenberg
Innere Medizin IV (Hämatologie und Onkologie), Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Ulm AöR
Comprehensive Cancer Center Ulm (CCCU), Albert-Einstein-Allee 23, Eselsberg, Ulm
Ospedale San Raffaele S.r.l.
Strategic Research Program on CLL, Via Olgettina 60, 20132, Milan
Hospital Santa Maria Della Misericordia
Medicine and Surgery, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliero Universitaria Pisana
UO Ematologia, Via Roma 67, 56126, Pisa
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department of Molecular Biotechology and Health Sciences, Division of Hematology, Corso Bramante 88, 10126, Turin
ASST Grande Ospedale Metropolitano Niguarda
S.C. Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Ematologia e Trapianto di cellule staminali emopoietiche, Largo Francesco Vito 1, 00168, Rome
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 |
|---|---|---|---|---|---|
| Germany | 2024-10-15 | ||||
| Italy | 2024-12-11 | 2025-01-27 | 2025-05-09 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-01 | Germany | Acceptable 2024-08-22
|
2024-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-02 | Acceptable | 2024-09-26 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-11 | Germany | Acceptable 2025-05-02
|
2025-05-06 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-30 | Germany | Acceptable 2025-05-02
|
2025-05-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-21 | Acceptable 2025-12-15
|
2026-01-26 |