Clinical trial • Phase I • Oncology

ABBV-101 for B-cell malignancies | Non-Hodgkin B-cell lymphoma

Phase I trial of ABBV-101 for B-cell malignancies | Non-Hodgkin B-cell lymphoma. 165 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
B-cell malignancies | Non-Hodgkin B-cell lymphoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
26-01-2024
First CTIS Authorization Date
22-05-2024

Trial design

Phase I trial across 24 sites in France, Spain, Germany and others.

Target Sample Size
165

Eligibility

Recruits 165 Vulnerable populations selected; no details on consent or assent handling provided in the available documents..

Vulnerable Population
Vulnerable populations selected; no details on consent or assent handling provided in the available documents.

Recruitment

Planned Sample Size
165
Recruitment Window Months
57

Geography

Total Number Of Sites
24
Total Number Of Participants
225

France

Earliest CTIS Part Ii Submission Date
03-05-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
674
Number Of Sites
6
Number Of Participants
102

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology
Contact Person Name
Benoit Tessoulin
Contact Person Email
benoit.tessoulin@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Clinical Hematology
Contact Person Name
Guillaume Cartron
Contact Person Email
g-cartron@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hematology
Contact Person Name
Franck Morschhauser
Site Name
Institut Bergonie
Department Name
Hematology
Contact Person Name
Fontanet Bijou
Contact Person Email
f.bijou@bordeaux.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Hematology
Contact Person Name
Vincent Ribrag
Site Name
Hopital Saint Louis
Department Name
Hemato-Oncology
Contact Person Name
Catherine Thieblemont
Contact Person Email
catherine.thieblemont@aphp.fr

Spain

Earliest CTIS Part Ii Submission Date
10-05-2024
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
671
Number Of Sites
6
Number Of Participants
48

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Contact Person Name
Jose Antonio Garcia Vela
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Daniel Morillo Giles
Contact Person Email
dmorillo@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Pau Abrisqueta Costa
Contact Person Email
pabrisqueta@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Javier Lopez Jimenez
Contact Person Email
jljimenez@salud.madrid.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Damian Cubillas Garcia de la Torre
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology
Contact Person Name
Almudena Navarro Bailón

Germany

Earliest CTIS Part Ii Submission Date
30-04-2024
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
680
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik m. S. Haematologie, Onkologie und Tumorimmunoloige CVK
Contact Person Name
Marie Luise Hütter-Krönke
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik-Haematologie und Onkologie
Contact Person Name
Franziska Westendorf
Contact Person Email
f.modemann@uke.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Med. Klinik und Poliklinik II
Contact Person Name
Johannes Duell
Contact Person Email
duell_j@ukw.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Department of Hematology, Oncology and Clinical Immunology
Contact Person Name
Mareike Dietrich
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Innere Medizin I
Contact Person Name
Lorenz Thurner
Contact Person Email
lorenz.thurner@uks.eu
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Comprehensive Cancer Center Ulm (CCCU) – Early Clinical Trials Unit (ECTU)
Contact Person Name
Stephan Stilgenbauer
Site Name
Zentrum Fuer Innere Medizin
Department Name
Klinik f. Innere Medizin III Onkologie
Contact Person Name
Sebastian Boettcher

Italy

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
715
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
Ematologia
Contact Person Name
Candida Vitale
Contact Person Email
candida.vitale@unito.it
Site Name
San Raffaele Hospital
Department Name
Strategic Research Program on Chronic Lymphocytic Leukemia, Division of Experimental Oncology
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name
Ematologia
Contact Person Name
Giuseppe Gritti
Contact Person Email
g.gritti@asst-pg23.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Ematologia
Contact Person Name
Anna MAria Frustaci
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Ematologia
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it

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-101
Routes Of Administration
oral
Route
oral

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