Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
390
Countries
4
Sites
24
Select B-Cell malignancies.
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 Jul 2024 → ongoing
- Decision date (initial)
- 2024-05-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503594-38-00
- ClinicalTrials.gov
- NCT05753501
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Select B-Cell malignancies.
| 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
4 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 102 | 6 |
| Germany | Ongoing, recruitment ended | 50 | 7 |
| Italy | Ongoing, recruitment ended | 25 | 5 |
| Spain | Ongoing, recruitment ended | 48 | 6 |
| Rest of world
Canada, United Kingdom, United States, Japan, Israel
|
— | 165 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
Clinical Hematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Lille
Hematology, Rue Michel Polonovski, 59037, Lille Cedex
Institut Gustave Roussy
Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
Hopital Saint Louis
Hemato-Oncology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Nantes
Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Bergonie
Hematology, 229 Cours De L Argonne, 33000, Bordeaux
Zentrum Fuer Innere Medizin
Klinik f. Innere Medizin III Onkologie, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik m. S. Haematologie, Onkologie und Tumorimmunoloige CVK, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Ulm AöR
Comprehensive Cancer Center Ulm (CCCU) – Early Clinical Trials Unit (ECTU), Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Wuerzburg AöR
Med. Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum des Saarlandes AöR
Klinik für Innere Medizin I, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Duesseldorf AöR
Department of Hematology, Oncology and Clinical Immunology, Moorenstrasse 5, Bilk, Duesseldorf
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik-Haematologie und Onkologie, Martinistrasse 52, Eppendorf, Hamburg
ASST Grande Ospedale Metropolitano Niguarda
Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
San Raffaele Hospital
Strategic Research Program on Chronic Lymphocytic Leukemia, Division of Experimental Oncology, Via Olgettina 58, 20132, Milan
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Ematologia, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Ematologia, Piazza Oms 1, 24127, Bergamo
Hospital Universitario De Salamanca
Oncology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
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 | 2024-08-20 | 2024-10-23 | 2026-01-29 | ||
| Germany | 2024-07-15 | 2024-11-07 | 2026-01-29 | ||
| Italy | 2025-04-10 | 2025-07-30 | 2026-01-29 | ||
| Spain | 2024-07-15 | 2024-09-17 | 2026-01-29 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-26 | Italy | Acceptable 2024-05-20
|
2024-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-31 | Acceptable | 2024-06-10 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-01 | Italy | Acceptable | 2024-07-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-13 | Italy | Acceptable 2025-03-31
|
2025-04-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-21 | Italy | Acceptable 2026-03-06
|
2026-03-10 |