Clinical trial • Phase I • Haematology

ELVN-001 for Chronic myeloid leukemia

Phase I trial of ELVN-001 for Chronic myeloid leukemia. 95 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Chronic myeloid leukemia
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
15-04-2024
First CTIS Authorization Date
17-05-2024

Trial design

Phase I trial across 26 sites in Spain, Italy, Belgium and others.

Target Sample Size
95

Recruitment

Planned Sample Size
95
Recruitment Window Months
67

Geography

Total Number Of Sites
26
Total Number Of Participants
145

Spain

Earliest CTIS Part Ii Submission Date
23-03-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
781
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Hospital Universitario La Paz
Department Name
Hematología
Contact Person Name
María Raquel Paz Arias
Contact Person Email
mraquelde.paz@salud.madrid.org
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematología
Contact Person Name
Elvira Mora Castera
Contact Person Email
mora_elv@gva.es
Site Name
Hospital Del Mar
Department Name
Hematología
Contact Person Name
Patricia Vélez Tenza
Contact Person Email
Patricia.velez.tenza@psmar.cat

Italy

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
404
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD dermatology
Contact Person Name
Erika Morsia
Contact Person Email
e.morsia@univpm.it

Belgium

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
404
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
UZ Leuven
Department Name
Hematology
Contact Person Name
Peter Vandenberghe
Contact Person Email
peter.vandenberghe@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Contact Person Name
Dominiek Mazure
Contact Person Email
dominiek.mazure@uzgent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematology
Contact Person Name
Marie Lejeune
Contact Person Email
marie.lejeune@chuliege.be

Poland

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
406
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologii
Contact Person Name
Ewa Lech-Marańda
Contact Person Email
onkocwbk@ihit.waw.pl
Site Name
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
Department Name
Oddział hematologiczny
Contact Person Name
Szymon Fornagiel
Contact Person Email
ho@szpitalnowysacz.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Toruń
Contact Person Name
Dominik Chraniuk

France

Earliest CTIS Part Ii Submission Date
23-03-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
779
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service d’Hématologie Clinique et Thérapie Cellulaire
Contact Person Name
Amandine Charbonnier
Contact Person Email
quint.marine@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des Maladies du Sang
Contact Person Name
Valerie Coiteux
Contact Person Email
valerie.coiteux@chru-lille.fr
Site Name
Centre Leon Berard
Department Name
Service d’Oncologie Médicale
Contact Person Name
Franck Nicolini
Site Name
Institut Bergonie
Department Name
Service Hématologie
Contact Person Name
Gabriel Etienne
Contact Person Email
m.fort@bordeaux.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Service Hématologie
Contact Person Name
Marie Balsat
Contact Person Email
ls.rc-hemato-ly@chu-lyon.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service d’Hématologie Clinique et Thérapie Cellulaire
Contact Person Name
Pascal Turlure

Netherlands

Earliest CTIS Part Ii Submission Date
22-04-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
386
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Department of Hematology
Contact Person Name
N.M.A. Blijlevens
Contact Person Email
laura.willemse@radboudumc.nl

Germany

Earliest CTIS Part Ii Submission Date
23-03-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
781
Number Of Sites
7
Number Of Participants
60

Sites

Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie
Contact Person Name
Andreas Hochhaus
Site Name
Universitat Heidelberg
Department Name
III. Medizinische Klinik
Contact Person Name
Susanne Saussele
Site Name
Rostock University Medical Center
Department Name
Innere Medizin, Klinik III – Hämatologie, Onkologie, Palliativmedizin
Contact Person Name
Christian Junghanß
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus VirchowKlinikum Medizinische Klinik mit Schwerpunkt Hämatologie,Onkologie und Tumorimmunogie
Contact Person Name
Philipp le Coutre
Contact Person Email
philipp.lecoutre@charite.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV)
Contact Person Name
Martina Crysandt
Contact Person Email
mcrysandt@ukaachen.de
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II Hämatologie/Onkologie
Contact Person Name
Fabian Lang
Contact Person Email
fabian.lang@kgu.de
Site Name
Universitaet Des Saarlandes
Department Name
Department of Oncology, Haematology, Rheumatology and clinical Immunology
Contact Person Name
Sarah Altmeyer
Contact Person Email
sarah.altmeyer@uks.eu

Hungary

Earliest CTIS Part Ii Submission Date
24-03-2025
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
417
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Semmelweis University
Contact Person Name
Istvan Takacs
Contact Person Email
takacs.istvan@semmelweis.hu
Site Name
University Of Pecs
Contact Person Name
Hussain Alizadeh
Contact Person Email
alizadeh.hussain@pte.hu

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
ELVN-001

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