Clinical trial • Phase I • Oncology
ABBV-319 for Follicular lymphoma|Chronic lymphocytic leukemia|Diffuse large B-cell lymphoma|B-cell malignancies
Phase I trial of ABBV-319 for Follicular lymphoma|Chronic lymphocytic leukemia|Diffuse large B-cell lymphoma|B-cell malignancies. 76 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Follicular lymphoma|Chronic lymphocytic leukemia|Diffuse large B-cell lymphoma|B-cell malignancies
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 24-03-2025
- First CTIS Authorization Date
- 14-07-2025
Trial design
Phase I trial across 12 sites in Italy, France, Spain.
- Target Sample Size
- 76
Recruitment
- Planned Sample Size
- 76
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 44
Italy
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 25-07-2025
- Processing Time Days
- 60
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Department of Hematology and Oncology
- Principal Investigator Name
- Giuseppe Gritti
- Principal Investigator Email
- g.gritti@asst-pg23.it
- Contact Person Name
- Giuseppe Gritti
- Contact Person Email
- g.gritti@asst-pg23.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Dipartimento Scienze Biomediche
- Principal Investigator Name
- Carmelo Carlo-Stella
- Principal Investigator Email
- carmelo.carlostella@hunimed.eu
- Contact Person Name
- Carmelo Carlo-Stella
- Contact Person Email
- carmelo.carlostella@hunimed.eu
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Strategic Research Program on CL
- Principal Investigator Name
- Paolo Ghia
- Principal Investigator Email
- ghia.paolo@hsr.it
- Contact Person Name
- Paolo Ghia
- Contact Person Email
- ghia.paolo@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- OUC Haematology
- Principal Investigator Name
- Pier Luigi Zinzan
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Pier Luigi Zinzan
- Contact Person Email
- pierluigi.zinzani@unibo.it
France
- Earliest CTIS Part Ii Submission Date
- 10-07-2025
- Latest Decision Or Authorization Date
- 22-09-2025
- Processing Time Days
- 74
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pavillion 1 F Marcel Berard 3e étage Service Hématologie Clinique
- Principal Investigator Name
- Emmanuel Bachy
- Principal Investigator Email
- emmanuel.bachy@chu-lyon.fr
- Contact Person Name
- Emmanuel Bachy
- Contact Person Email
- emmanuel.bachy@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Clinical Hematology Department
- Principal Investigator Name
- Benoit Tessoulin
- Principal Investigator Email
- benoit.tessoulin@chu-nantes.fr
- Contact Person Name
- Benoit Tessoulin
- Contact Person Email
- benoit.tessoulin@chu-nantes.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d’Innovations Thérapeutiques et d’essais Précoces (DITEP)
- Principal Investigator Name
- Vincent Ribrag
- Principal Investigator Email
- vincent.ribrag@gustaveroussy.fr
- Contact Person Name
- Vincent Ribrag
- Contact Person Email
- vincent.ribrag@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Contact Person Name
- n/a n/a
- Contact Person Email
- vincent.ribrag@gustaveroussy.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 01-07-2025
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 259
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Start Madrid-Hematology
- Principal Investigator Name
- Daniel Morillo Giles
- Principal Investigator Email
- dmorillo@startmadrid.com
- Contact Person Name
- Daniel Morillo Giles
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Pau Abrisqueta Costa
- Principal Investigator Email
- pabrisqueta@vhio.net
- Contact Person Name
- Pau Abrisqueta Costa
- Contact Person Email
- pabrisqueta@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Pablo Javier Mozas Fernández
- Principal Investigator Email
- mozas@clinic.cat
- Contact Person Name
- Pablo Javier Mozas Fernández
- Contact Person Email
- mozas@clinic.cat
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematology
- Principal Investigator Name
- Sonia González de Villambrosia
- Principal Investigator Email
- sonia.glezdevillambrosi@scsalud.es
- Contact Person Name
- Sonia González de Villambrosia
- Contact Person Email
- sonia.glezdevillambrosi@scsalud.es
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- ABBV-319
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
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