Clinical trial • Phase III • Oncology

ABBV-453 for Small lymphocytic lymphoma | Chronic lymphocytic leukemia

Phase III trial of ABBV-453 for Small lymphocytic lymphoma | Chronic lymphocytic leukemia. 54 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small lymphocytic lymphoma | Chronic lymphocytic leukemia
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
01-05-2024
First CTIS Authorization Date
23-08-2024

Trial design

Phase III trial in Germany, Italy.

Target Sample Size
54

Recruitment

Planned Sample Size
54
Recruitment Window Months
61

Geography

Total Number Of Sites
15
Total Number Of Participants
26

Germany

Earliest CTIS Part Ii Submission Date
15-08-2024
Latest Decision Or Authorization Date
26-08-2024
Processing Time Days
11
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Poliklinik II
Contact Person Name
Johannes Düll
Contact Person Email
duell_j@ukw.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Clinic of Hematology, Oncology and Palliative Medicine
Contact Person Name
Julia von Tresckow
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Contact Person Name
Walter Fiedler
Contact Person Email
p.kuehne@uke.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Dept. of Hematology, Onocology and Tumorimmunology
Contact Person Name
Marie Luise Hütter-Krönke
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Innere Medizin IV (Hämatologie und Onkologie)
Contact Person Name
Christine Dierks
Site Name
Klinikum Chemnitz gGmbH
Department Name
Internal Medicine III
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Innere Medizin II - Hämatologie, Onkologie
Contact Person Name
Matthias Ritgen
Contact Person Email
Matthias.Ritgen@uksh.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Comprehensive Cancer Center Ulm (CCCU)
Contact Person Name
Christof Schneider

Italy

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
38
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Strategic Research Program on CLL
Contact Person Name
Paolo Prospero 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
Dipartimento Malattie Oncologiche ed Ematologiche
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Ematologia
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@med.unipi.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Ematologia
Contact Person Name
Anna Maria Frustaci
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Ematologia e Trapianto di cellule staminali emopoietiche
Contact Person Name
Luca Laurenti
Contact Person Email
luca.laurenti@unicatt.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Department of Molecular Biotechology and Health Sciences, Division of Hematology
Contact Person Name
Candida Vitale
Contact Person Email
candida.vitale@unito.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Medicine and Surgery
Contact Person Name
Paolo Sportoletti
Contact Person Email
paolo.sportoletti@unipg.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-453
Routes Of Administration
Oral
Route
Oral

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