Clinical trial • Phase III • Oncology

Clinical trial in Non-Hodgkin lymphoma|Chronic lymphocytic leukemia

Phase III trial for Non-Hodgkin lymphoma|Chronic lymphocytic leukemia. open-label. 65 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-Hodgkin lymphoma|Chronic lymphocytic leukemia
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
27-08-2024
First CTIS Authorization Date
16-12-2024

Trial design

open-label Phase III trial across 20 sites in France, Poland, Greece and others.

Open Label
Yes
Target Sample Size
65
Trial Duration For Participant
730

Recruitment

Planned Sample Size
65
Recruitment Window Months
24

Geography

Total Number Of Sites
20
Total Number Of Participants
52

France

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
515
Number Of Sites
6
Number Of Participants
5

Sites

Site Name
Institut Curie
Department Name
Unité d’Investigation Clinique Adulte
Contact Person Name
Clémentine SARKOZY
Contact Person Email
clementine.sarkozy@curie.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hopital Claude Huriez - Service des Maladies du sang
Contact Person Name
Franck MORSCHHAUSER
Site Name
Oncopole Claudius Regaud
Department Name
Institut Universitaire du Cancer I.U.C.Toulouse – Oncopôle Département Hématologie
Contact Person Name
Loïc Ysebaert
Contact Person Email
ysebaert.loic@iuct-oncopole.fr
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
Institut Paoli Calmettes
Department Name
Hematology Department
Contact Person Name
Robin NOEL
Contact Person Email
noelr@ipc.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Département d’Innovations Thérapeutiques et d’essais Précoces (DITEP)
Contact Person Name
Vincent RIBRAG

Poland

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
516
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Osrodek Badan Klinicznych Wczesnych Faz
Contact Person Name
Jan Maciej Zaucha
Contact Person Email
jan.zaucha@gumed.edu.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM
Contact Person Name
Wojciech Jurczak
Contact Person Email
rejestracja.mcm@pratia.com
Site Name
Aidport Sp. z o.o.
Department Name
Aidport Sp z o o
Contact Person Name
Michal Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Contact Person Name
Sebastian Grosicki

Greece

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
579
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
General Hospital Of Athens Alexandra
Department Name
Department of Clinical Therapeutics
Contact Person Name
Maria Gavriatopoulou
Contact Person Email
mgavria@med.uoa.gr

Belgium

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
514
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Contact Person Name
Ciel De Vriendt
Contact Person Email
studies.hematologie@uzgent.be

Spain

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
315
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology department
Contact Person Name
Bernard Doger de Speville
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology Department
Contact Person Name
Pau Abrisqueta Costa
Contact Person Email
pabrisqueta@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Hematology Department
Contact Person Name
Ana Alonso Piérola
Contact Person Email
aalfonso@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology Department
Contact Person Name
Tycho Baumann
Contact Person Email
tycho.baumann@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology department
Contact Person Name
Irene Braña García
Contact Person Email
ibrana@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Hematology Department
Contact Person Name
Miguel Angel Canales
Contact Person Email
macanales@unav.es
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology Department
Contact Person Name
Andrea Rivero Arango
Contact Person Email
anrivero@clinic.cat
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology Department
Contact Person Name
Norma Gutierrez Gutierrez
Contact Person Email
normagu@usal.es

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

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