Clinical trial • Phase II • Oncology

selinexor for Diffuse large B-cell lymphoma (DLBCL) | Relapsed/refractory DLBCL

Phase II trial of selinexor for Diffuse large B-cell lymphoma (DLBCL) | Relapsed/refractory DLBCL. open-label, none/not specified-controlled.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Diffuse large B-cell lymphoma (DLBCL) | Relapsed/refractory DLBCL
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-05-2024
First CTIS Authorization Date
24-06-2024

Trial design

open-label, none/not specified-controlled Phase II trial across 13 sites in Poland, Greece, Italy.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
30

Recruitment

Planned Sample Size
30
Recruitment Window Months
56

Geography

Total Number Of Sites
13
Total Number Of Participants
30

Poland

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Wojewodzki Szpital Specjalistyczny W Legnicy
Department Name
Oddział Hematologii
Contact Person Name
Jadwiga Hołojda
Contact Person Email
sekretariat@szpital.legnica.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Contact Person Name
Tomasz Wróbel
Contact Person Email
tomasz.wrobel@umed.wroc.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Chłonnego
Contact Person Name
Joanna Romejko-Jarosińska

Greece

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
09-09-2024
Processing Time Days
40
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Department Of Haematology, Haematopoietic Cell Transplantation Centre
Contact Person Name
Niki Stavroyianni
Contact Person Email
niki.stavroyianni@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
Hematology Clinic
Contact Person Name
Theodoros Vassilakopoulos
Site Name
General Hospital Of Athens G Gennimatas
Department Name
Hematology Clinic
Contact Person Name
Efthimia Mpazani
Contact Person Email
mpazani@hotmail.com
Site Name
University General Hospital Attikon
Department Name
B’ Department of Internal Medicine Propaedeutic, Haematology Division
Contact Person Name
Panagiotis Tsirigotis
Contact Person Email
panagtsirigotis@gmail.com
Site Name
University General Hospital Of Ioannina
Department Name
Department of Clinical Hematology
Contact Person Name
Eleni Kapsali
Contact Person Email
elkapsali@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
25-06-2024
Processing Time Days
25
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Hematology
Contact Person Name
Stefan Hohaus
Contact Person Email
stefan.hohaus@unicatt.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Oncology
Contact Person Name
Riccardo Bruna
Contact Person Email
riccardo.bruna@med.uniupo.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
hematology
Contact Person Name
Alberto Fabbri
Contact Person Email
fabbri7@unisi.it
Site Name
Careggi University Hospital
Department Name
Hematology
Contact Person Name
Luca Nassi
Contact Person Email
nassil@aou-careggi.toscana.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
homatology
Contact Person Name
Antonio Pinto
Contact Person Email
a.pinto@istitutotumori.na.it

Sponsor

Primary sponsor

Full Name
Karyopharm Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
Selinexor (KPT-330)
Active Substance
selinexor
Modality
Small molecule

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