Clinical trial • Phase III • Oncology

BLEXIMENIB for Acute myeloid leukemia

Phase III trial of BLEXIMENIB for Acute myeloid leukemia.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Acute myeloid leukemia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
04-09-2025
First CTIS Authorization Date
15-01-2026

Trial design

Randomised, placebo to match bleximenib 50 mg and placebo to match bleximenib 100 mg (used as comparator arms versus bleximenib, in combination with standard induction and consolidation chemotherapy).-controlled Phase III trial in Austria, Denmark, Estonia and others.

Randomised
Yes
Comparator
Placebo to match bleximenib 50 mg and placebo to match bleximenib 100 mg (used as comparator arms versus bleximenib, in combination with standard induction and consolidation chemotherapy).
Target Sample Size
604

Eligibility

Recruits 604 No vulnerable population selected. Inclusion requires ≥18 years of age (or legal age of majority) at the time of informed consent. Informed consent is provided by the participant..

Vulnerable Population
No vulnerable population selected. Inclusion requires ≥18 years of age (or legal age of majority) at the time of informed consent. Informed consent is provided by the participant.

Inclusion criteria

  • {"criterion_text":"- 1. \t≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.\n- 2.\tNew diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.\n- 3.\tConsidered eligible for intensive chemotherapy.\n- 4.\tWHO/ECOG performance status ≤2.\n- 5.\tAdequate renal and hepatic functions prior to randomization:\n- 6. White blood cell (WBC) count <25 × 109/L."}

Exclusion criteria

  • {"criterion_text":"- 3.\tPrior (chemo-)therapy for AML, including prior treatment with hypomethylating agents\n- 4.\tKnown active leukemic involvement of the central nervous system (CNS).\n- 5.\tRecipient of solid organ transplant.\n- 6.\tCardiac disease: a.\tAny of the following within 6 months of randomization: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class III or IV), uncontrolled or symptomatic arrhythmias, stroke, or transient ischemic attack. b.\tQTc interval using Fridericia’s formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted. c.Left ventricular ejection fraction (LVEF) <40% by ECHO or MUGA scan (only if ECHO or MUGA was performed for clinical indication within 28 days prior to the start of study treatment) d.\tPreviously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg/m2.\n- 7\tChronic respiratory disease requiring supplemental oxygen.\n- 8.\tActive infection, including hepatitis B or C or HIV infection that is uncontrolled at randomization. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- EFS, defined as the time from randomization to failure to achieve CR after remission induction, hematologic relapse after achieving CR, or death, whichever occurs first.","definition_or_measurement_approach":"EFS, defined as the time from randomization to failure to achieve CR after remission induction, hematologic relapse after achieving CR, or death, whichever occurs first."}

Recruitment

Planned Sample Size
604
Recruitment Window Months
96
Consent Approach
Informed consent is obtained from the participant (inclusion requires ≥18 years or legal age of majority). Country-specific informed consent forms are provided; pregnancy-specific ICFs and country/language versions are available.

Geography

Total Number Of Sites
137
Total Number Of Participants
423

Austria

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
18-01-2026
Processing Time Days
32
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Interne E am LKH Rankweil
Principal Investigator Name
Bernd Hartmann
Principal Investigator Email
Bernd.hartmann@lkhf.at
Contact Person Name
Bernd Hartmann
Contact Person Email
Bernd.hartmann@lkhf.at
Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
3.Medizinische Abteilung
Principal Investigator Name
Elisabeth Koller
Principal Investigator Email
elisabeth.koller@oegk.at
Contact Person Name
Elisabeth Koller
Contact Person Email
elisabeth.koller@oegk.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Interne 1 - Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie
Principal Investigator Name
Sigrid Machherndl-Spandl
Principal Investigator Email
sigrid.machherndl-spandl@ordensklinikum.at
Contact Person Name
Sigrid Machherndl-Spandl

Denmark

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
12
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Region Midtjylland
Department Name
Hematology
Principal Investigator Name
Anne Stidsholt Roug
Principal Investigator Email
ANNROU@rm.dk
Contact Person Name
Anne Stidsholt Roug
Contact Person Email
ANNROU@rm.dk
Site Name
Aalborg University Hospital
Department Name
Hematology
Principal Investigator Name
Gitte Thomsen
Principal Investigator Email
gith@rn.dk
Contact Person Name
Gitte Thomsen
Contact Person Email
gith@rn.dk
Site Name
Odense University Hospital
Department Name
Hematology
Principal Investigator Name
Dennis Lund Hansen
Principal Investigator Email
dennis.lund.hansen2@rsyd.dk
Contact Person Name
Dennis Lund Hansen
Contact Person Email
dennis.lund.hansen2@rsyd.dk
Site Name
Rigshospitalet
Department Name
Hematology
Principal Investigator Name
Anne Louise Tølbøll Sørensen
Principal Investigator Email
anne.louise.toelboell.soerensen@regionh.dk
Contact Person Name
Anne Louise Tølbøll Sørensen

Estonia

Earliest CTIS Part Ii Submission Date
09-04-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
13
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
North Estonia Medical Centre Foundation
Department Name
Haematology and Oncology Centre
Principal Investigator Name
Katrin Palk
Principal Investigator Email
katrin.palk@regionaalhaigla.ee
Contact Person Name
Katrin Palk
Contact Person Email
katrin.palk@regionaalhaigla.ee
Site Name
Tartu University Hospital
Department Name
Oncology Clinic
Principal Investigator Name
Ain Kaare
Principal Investigator Email
ain.kaare@kliinikum.ee
Contact Person Name
Ain Kaare
Contact Person Email
ain.kaare@kliinikum.ee

Finland

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
14
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
Department of Oncology/ Hematology
Principal Investigator Name
Kirsi Launonen
Principal Investigator Email
Kirsi.launonen@pohde.fi
Contact Person Name
Kirsi Launonen
Contact Person Email
Kirsi.launonen@pohde.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Department of Hematology
Principal Investigator Name
Antti Turunen
Principal Investigator Email
antti.s.turunen@pshyvinvointialue.fi
Contact Person Name
Antti Turunen
Site Name
Tampere University Hospital
Department Name
Department of Hematology
Principal Investigator Name
Johanna Rimpiläinen
Principal Investigator Email
Johanna.rimpilainen@pirha.fi
Contact Person Name
Johanna Rimpiläinen
Contact Person Email
Johanna.rimpilainen@pirha.fi
Site Name
HUS-yhtymae
Department Name
Department of Hematology
Principal Investigator Name
Mika Kontro
Principal Investigator Email
Mika.Kontro@helsinki.fi
Contact Person Name
Mika Kontro
Contact Person Email
Mika.Kontro@helsinki.fi
Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Department of Clinical Haematology and Stem Cell Transplant Unit
Principal Investigator Name
Pia Ettala
Principal Investigator Email
Pia.ettala@varha.fi
Contact Person Name
Pia Ettala
Contact Person Email
Pia.ettala@varha.fi

Ireland

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
30
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Beaumont Hospital
Department Name
Haematology
Principal Investigator Name
John Quinn
Principal Investigator Email
johnquinn@beaumont.ie
Contact Person Name
John Quinn
Contact Person Email
johnquinn@beaumont.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Haematology
Principal Investigator Name
Michael Fay
Principal Investigator Email
michaelFay@mater.ie
Contact Person Name
Michael Fay
Contact Person Email
michaelFay@mater.ie
Site Name
St James's Hospital
Department Name
Haematology
Principal Investigator Name
Nina Orfali
Principal Investigator Email
norfali@stjames.ie
Contact Person Name
Nina Orfali
Contact Person Email
norfali@stjames.ie
Site Name
Cork University Hospital
Department Name
Haematology
Principal Investigator Name
Vitaliy Mykytiv
Principal Investigator Email
Vitaliy.mykytiv@hse.ie
Contact Person Name
Vitaliy Mykytiv
Contact Person Email
Vitaliy.mykytiv@hse.ie
Site Name
University Hospital Galway
Department Name
Haematology
Principal Investigator Name
Janusz Krawczyk
Principal Investigator Email
Janusz.krawczyk@hse.ie
Contact Person Name
Janusz Krawczyk
Contact Person Email
Janusz.krawczyk@hse.ie
Site Name
St Vincent's University Hospital
Department Name
Haematology
Principal Investigator Name
Claire Andrews
Principal Investigator Email
claireandrews@st-vincents.ie
Contact Person Name
Claire Andrews
Contact Person Email
claireandrews@st-vincents.ie

Italy

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
69
Number Of Sites
13
Number Of Participants
45

Sites

Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Department of Hematology and Oncology
Principal Investigator Name
Federico Lussana
Principal Investigator Email
flussana@asst-pg23.it
Contact Person Name
Federico Lussana
Contact Person Email
flussana@asst-pg23.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medicina Interna
Principal Investigator Name
Lorenzo Brunetti
Principal Investigator Email
lorenzo.brunetti@staff.univpm.it
Contact Person Name
Lorenzo Brunetti
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncoematologia
Principal Investigator Name
Michele Gottardi
Principal Investigator Email
michele.gottardi@iov.veneto.it
Contact Person Name
Michele Gottardi
Contact Person Email
michele.gottardi@iov.veneto.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dipartimento Area Medica -S.C. EMATOLOGIA
Principal Investigator Name
Nicola Stefano Fracchiolla
Principal Investigator Email
nicola.fracchiolla@pliclinico.mi.it
Contact Person Name
Nicola Stefano Fracchiolla
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Hematology and Cell Therapy
Principal Investigator Name
Germana Beltrami
Principal Investigator Email
germana.beltrami@hsanmartino.it
Contact Person Name
Germana Beltrami
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Department of Experimental and Clinical Medicine
Principal Investigator Name
Francesco Mannelli
Principal Investigator Email
francesco.mannelli@unifi.it
Contact Person Name
Francesco Mannelli
Contact Person Email
francesco.mannelli@unifi.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S. C. Hematology
Principal Investigator Name
Roberto Cairoli
Principal Investigator Email
roberto.cairoli@ospedaleniguarda.it
Contact Person Name
Roberto Cairoli
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Department of Medicine and Surgery, Hematology Unit
Principal Investigator Name
Maria Paola Martelli
Principal Investigator Email
maria.martelli@unipg.it
Contact Person Name
Maria Paola Martelli
Contact Person Email
maria.martelli@unipg.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
U.O.C. Oncoematologia
Principal Investigator Name
Antonino Mulè
Principal Investigator Email
a.mule@villasofia.it
Contact Person Name
Antonino Mulè
Contact Person Email
a.mule@villasofia.it
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
Dipartimento oncologico-ematologico
Principal Investigator Name
Giulia De Luca
Principal Investigator Email
giulia.deluca@asl.pe.it
Contact Person Name
Giulia De Luca
Contact Person Email
giulia.deluca@asl.pe.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncology and Hematology Department
Principal Investigator Name
Francesco Lanza
Principal Investigator Email
francesco.lanza@auslromagna.it
Contact Person Name
Francesco Lanza
Contact Person Email
francesco.lanza@auslromagna.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
Hematology Dept and Bone Marrow Transplantation
Principal Investigator Name
Angelo Michele Carella
Principal Investigator Email
am.carella@operapadrepio.it
Contact Person Name
Angelo Michele Carella
Contact Person Email
am.carella@operapadrepio.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Department of Translational and Precision Medicine
Principal Investigator Name
Silvia Maria Trisolini
Principal Investigator Email
trisolini@bce.uniroma1.it
Contact Person Name
Silvia Maria Trisolini
Contact Person Email
trisolini@bce.uniroma1.it

Lithuania

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
25
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Principal Investigator Name
Andrius Žučenka
Principal Investigator Email
andrius.zucenka@santa.lt
Contact Person Name
Andrius Žučenka
Contact Person Email
andrius.zucenka@santa.lt

Spain

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
11
Number Of Sites
13
Number Of Participants
26

Sites

Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Haematology
Principal Investigator Name
Montserrat Arnan Sangermen
Principal Investigator Email
marnan@iconcologia.net
Contact Person Name
Montserrat Arnan Sangermen
Contact Person Email
marnan@iconcologia.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Haematology
Principal Investigator Name
Gabriela Rodríguez Macías
Principal Investigator Email
gabriela.rodriguez@salud.madrid.org
Contact Person Name
Gabriela Rodríguez Macías
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Haematology
Principal Investigator Name
Ana Garrido Diaz
Principal Investigator Email
agarridod@santpau.cat
Contact Person Name
Ana Garrido Diaz
Contact Person Email
agarridod@santpau.cat
Site Name
Hospital Del Mar
Department Name
Haematology
Principal Investigator Name
Sara García Ávila
Principal Investigator Email
sgarciaavila@parcdesalutmar.cat
Contact Person Name
Sara García Ávila
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Haematology
Principal Investigator Name
Susana Vives Polo
Principal Investigator Email
svives@iconcologia.net
Contact Person Name
Susana Vives Polo
Contact Person Email
svives@iconcologia.net
Site Name
University Hospital Son Espases
Department Name
Haematology
Principal Investigator Name
Antonia Sampol Mayol
Principal Investigator Email
antonia.sampolm@ssib.es
Contact Person Name
Antonia Sampol Mayol
Contact Person Email
antonia.sampolm@ssib.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Haematology
Principal Investigator Name
Mª del Mar Tormo Diaz
Principal Investigator Email
tormo_mar@gva.es
Contact Person Name
Mª del Mar Tormo Diaz
Contact Person Email
tormo_mar@gva.es
Site Name
Hospital Universitari Joan XXIII De Tarragona
Department Name
Haematology
Principal Investigator Name
Luiz Andre Aguilar Balta
Principal Investigator Email
luizaaguilarb@iconcologia.net
Contact Person Name
Luiz Andre Aguilar Balta
Contact Person Email
luizaaguilarb@iconcologia.net
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Haematology
Principal Investigator Name
Ferrán Vall-Llovera Calmet
Principal Investigator Email
fvall_llovera@mutuaterrassa.es
Contact Person Name
Ferrán Vall-Llovera Calmet
Contact Person Email
fvall_llovera@mutuaterrassa.es
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Haematology
Principal Investigator Name
Antonio García Guiñón
Principal Investigator Email
agarciag.lleida.ics@gencat.cat
Contact Person Name
Antonio García Guiñón
Contact Person Email
agarciag.lleida.ics@gencat.cat
Site Name
Hospital Son Llatzer
Department Name
Haematology
Principal Investigator Name
Antonia Cladera Serra
Principal Investigator Email
acladera@hsll.es
Contact Person Name
Antonia Cladera Serra
Contact Person Email
acladera@hsll.es
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Haematology
Principal Investigator Name
Rosa Coll Jorda
Principal Investigator Email
rcoll@iconcologia.net
Contact Person Name
Rosa Coll Jorda
Contact Person Email
rcoll@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Haematology
Principal Investigator Name
Jordi Esteve Reyner
Principal Investigator Email
jesteve@clinic.cat
Contact Person Name
Jordi Esteve Reyner
Contact Person Email
jesteve@clinic.cat

Sweden

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
44
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Hematologi, onkologi och strålningsfysik
Principal Investigator Name
Vladimir Lazarevic
Principal Investigator Email
vladimir.lazarevic@med.lu.se
Contact Person Name
Vladimir Lazarevic
Contact Person Email
vladimir.lazarevic@med.lu.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sektionen för Hematologi och koagulation
Principal Investigator Name
Lovisa Vennström
Principal Investigator Email
lovisa.vennstrom@vgregion.se
Contact Person Name
Lovisa Vennström
Contact Person Email
lovisa.vennstrom@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Hematologi
Principal Investigator Name
Martin Jädersten
Principal Investigator Email
martin.jadersten@regionstockholm.se
Contact Person Name
Martin Jädersten
Site Name
Uppsala University Hospital
Department Name
Hematologavdelning 101 A
Principal Investigator Name
Anna Robelius
Principal Investigator Email
anna.robelius@uu.se
Contact Person Name
Anna Robelius
Contact Person Email
anna.robelius@uu.se

Norway

Earliest CTIS Part Ii Submission Date
19-03-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
5
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Dept. of Hematology
Principal Investigator Name
Andrea Lenartova
Principal Investigator Email
anlena@ous-hf.no
Contact Person Name
Andrea Lenartova
Contact Person Email
anlena@ous-hf.no
Site Name
St. Olavs Hospital HF
Department Name
Dept. Of Hematology
Principal Investigator Name
Anne Sophie von Krogh
Principal Investigator Email
anne.sophie.von.krogh@stolav.no
Contact Person Name
Anne Sophie von Krogh
Site Name
Helse Stavanger HF
Department Name
Dept. Of Hematology
Principal Investigator Name
Waleed Majeed Mohammed
Principal Investigator Email
waleed.majeed.mohammed@sus.no
Contact Person Name
Waleed Majeed Mohammed
Contact Person Email
waleed.majeed.mohammed@sus.no
Site Name
Helse Bergen HF
Department Name
Dept. of Hematology
Principal Investigator Name
Bjørn Tore Gjertsen
Principal Investigator Email
bjorn.tore.gjertsen@helse-bergen.no
Contact Person Name
Bjørn Tore Gjertsen
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Blood and Endocrinology
Principal Investigator Name
Nils Morten Leknes
Principal Investigator Email
Nils.morten.leknes@unn.no
Contact Person Name
Nils Morten Leknes
Contact Person Email
Nils.morten.leknes@unn.no

Poland

Earliest CTIS Part Ii Submission Date
19-03-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
35
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii i Terapii komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Wróbel
Principal Investigator Email
tomasz.wrobel@umw.edu.pl
Contact Person Name
Tomasz Wróbel
Contact Person Email
tomasz.wrobel@umw.edu.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny im. A. Mielęckiego ŚUM w Katowicach
Department Name
Oddział Hematologii i Transplantacji Szpiku
Principal Investigator Name
Grzegorz Helbig
Principal Investigator Email
ghelbig@o2.pl
Contact Person Name
Grzegorz Helbig
Contact Person Email
ghelbig@o2.pl
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologi
Principal Investigator Name
Ewa Lech-Marańda
Principal Investigator Email
ewamaranda@wp.pl
Contact Person Name
Ewa Lech-Marańda
Contact Person Email
ewamaranda@wp.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii i Transplantologii i Chorób Wewnętrznych – Klinika Hematologii
Principal Investigator Name
Agnieszka Wierzbowska
Principal Investigator Email
agnieszka.wierzbowska@umed.lodz.pl
Contact Person Name
Agnieszka Wierzbowska
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Hematologii, Chorób Wewnętrznych i Angiologii z Pododdziałem Transplantacji Komórek K.
Principal Investigator Name
Łukasz Bołkun
Principal Investigator Email
lbolkun@gmail.com
Contact Person Name
Łukasz Bołkun
Contact Person Email
lbolkun@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne (Gdansk)
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Witold Prejzner
Principal Investigator Email
wpre@gumed.edu.pl
Contact Person Name
Witold Prejzner
Contact Person Email
wpre@gumed.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Centralny Szpital kliniczny, Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
Principal Investigator Name
Grzegorz Basak
Principal Investigator Email
grzegorz.basak@wum.edu.pl
Contact Person Name
Grzegorz Basak
Contact Person Email
grzegorz.basak@wum.edu.pl

Belgium

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
29
Number Of Sites
14
Number Of Participants
45

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Hematology
Principal Investigator Name
Eva De Backer
Principal Investigator Email
Eva.debacker2@uza.be
Contact Person Name
Eva De Backer
Contact Person Email
Eva.debacker2@uza.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematology
Principal Investigator Name
Adrien De Voeght
Principal Investigator Email
Adrien.devoeght@chuliege.be
Contact Person Name
Adrien De Voeght
Contact Person Email
Adrien.devoeght@chuliege.be
Site Name
Institut Jules Bordet
Department Name
Hematology
Principal Investigator Name
Sebastian Wittnebel
Principal Investigator Email
Sebastian.wittenebel@hubruxelles.be
Contact Person Name
Sebastian Wittnebel
Site Name
Ziekenhuis Geel
Department Name
Hematology
Principal Investigator Name
Ulrike Douven
Principal Investigator Email
Ulrike.douven@ziekenhuisgeel.be
Contact Person Name
Ulrike Douven
Site Name
CHU Helora
Department Name
Hematology
Principal Investigator Name
Raphaël Lattenist
Principal Investigator Email
Raphael.lattenist@helora.be
Contact Person Name
Raphaël Lattenist
Contact Person Email
Raphael.lattenist@helora.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Hematology
Principal Investigator Name
Dimitri Breems
Principal Investigator Email
dimitri.breems@zas.be
Contact Person Name
Dimitri Breems
Contact Person Email
dimitri.breems@zas.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology & hematology
Principal Investigator Name
Valérie Robin
Principal Investigator Email
Valerie.robin@ghdc.be
Contact Person Name
Valérie Robin
Contact Person Email
Valerie.robin@ghdc.be
Site Name
CHC MontLegia
Department Name
Hemato-oncology
Principal Investigator Name
Quentin Perlot
Principal Investigator Email
Quentin.perlot@chc.be
Contact Person Name
Quentin Perlot
Contact Person Email
Quentin.perlot@chc.be
Site Name
Jessa Ziekenhuis
Department Name
Hematology
Principal Investigator Name
Liesbet Lammertijn
Principal Investigator Email
Liesbet.lammertijn@jessazh.be
Contact Person Name
Liesbet Lammertijn
Contact Person Email
Liesbet.lammertijn@jessazh.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Principal Investigator Name
Tom Lodewyck
Principal Investigator Email
tom.lodewyck@azsintjan.be
Contact Person Name
Tom Lodewyck
Contact Person Email
tom.lodewyck@azsintjan.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology
Principal Investigator Name
Marie-Christiane Vekemans
Contact Person Name
Marie-Christiane Vekemans
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Principal Investigator Name
Thomas De Corte
Principal Investigator Email
Thomas.decorte@uzgent.be
Contact Person Name
Thomas De Corte
Contact Person Email
Thomas.decorte@uzgent.be
Site Name
UZ Leuven
Department Name
Hematology
Principal Investigator Name
Johan Maertens
Principal Investigator Email
Johan.maertens@uzleuven.be
Contact Person Name
Johan Maertens
Contact Person Email
Johan.maertens@uzleuven.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Principal Investigator Name
Elodie Collinge
Principal Investigator Email
Elodie.collinge@chuuclnamur.uclouvain.be
Contact Person Name
Elodie Collinge

Netherlands

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
29
Number Of Sites
18
Number Of Participants
69

Sites

Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Internal Medicine
Principal Investigator Name
Alexandra Herbers
Principal Investigator Email
a.herbers@jbz.nl
Contact Person Name
Alexandra Herbers
Contact Person Email
a.herbers@jbz.nl
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Internal Medicine
Principal Investigator Name
Maaike Söhne
Principal Investigator Email
sct@antoniusziekenhuis.nl
Contact Person Name
Maaike Söhne
Contact Person Email
sct@antoniusziekenhuis.nl
Site Name
Amphia Hospital
Department Name
Internal Medicine
Principal Investigator Name
Roel Fiets
Principal Investigator Email
rfiets@amphia.nl
Contact Person Name
Roel Fiets
Contact Person Email
rfiets@amphia.nl
Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Principal Investigator Name
David De Leeuw
Principal Investigator Email
hematology@amsterdamumc.nl
Contact Person Name
David De Leeuw
Contact Person Email
hematology@amsterdamumc.nl
Site Name
Frisius MC
Department Name
Oncology Center Leeuwarden
Principal Investigator Name
Bas Franken
Principal Investigator Email
Bas.Franken@frisiusmc.nl
Contact Person Name
Bas Franken
Contact Person Email
Bas.Franken@frisiusmc.nl
Site Name
Haga Hospital
Department Name
Hematology
Principal Investigator Name
Daniëlle van Lammeren-Venema
Principal Investigator Email
d.vanlammeren@hagaziekenhuis.nl
Contact Person Name
Daniëlle van Lammeren-Venema
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Hematology
Principal Investigator Name
Janine van Elssen
Principal Investigator Email
Research.hematologie@mumc.nl
Contact Person Name
Janine van Elssen
Contact Person Email
Research.hematologie@mumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hematology
Principal Investigator Name
Laura van Hussen-Daenen
Principal Investigator Email
hemat-research@umcutrecht.nl
Contact Person Name
Laura van Hussen-Daenen
Contact Person Email
hemat-research@umcutrecht.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematology
Principal Investigator Name
Marc Raaijmakers
Principal Investigator Email
m.h.g.raaijmakers@erasmusmc.nl
Contact Person Name
Marc Raaijmakers
Contact Person Email
m.h.g.raaijmakers@erasmusmc.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Hematology
Principal Investigator Name
Peter Westerweel
Principal Investigator Email
p.e.westerweel@asz.nl
Contact Person Name
Peter Westerweel
Contact Person Email
p.e.westerweel@asz.nl
Site Name
Isala Klinieken Stichting
Department Name
Internal Medicine
Principal Investigator Name
Tim de Waal
Principal Investigator Email
t.t.de.waal@isala.nl
Contact Person Name
Tim de Waal
Contact Person Email
t.t.de.waal@isala.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Hematology
Principal Investigator Name
Florentien In ‘t Hout
Principal Investigator Email
Studies.hemat@radboudumc.nl
Contact Person Name
Florentien In ‘t Hout
Contact Person Email
Studies.hemat@radboudumc.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Hematology
Principal Investigator Name
Marloes Cuijpers
Principal Investigator Email
mcuijpers@rijnstate.nl
Contact Person Name
Marloes Cuijpers
Contact Person Email
mcuijpers@rijnstate.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Principal Investigator Name
Gerwin Huls
Principal Investigator Email
g.huls@umcg.nl
Contact Person Name
Gerwin Huls
Contact Person Email
g.huls@umcg.nl
Site Name
Maxima Medisch Centrum
Department Name
Hematology
Principal Investigator Name
Lidwine Tick
Principal Investigator Email
l.tick@mmc.nl
Contact Person Name
Lidwine Tick
Contact Person Email
l.tick@mmc.nl
Site Name
Stichting OLVG
Department Name
Internal Disease
Principal Investigator Name
Hans Mooij
Principal Investigator Email
h.l.mooij@olvg.nl
Contact Person Name
Hans Mooij
Contact Person Email
h.l.mooij@olvg.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Department of Hematology
Principal Investigator Name
Hendrik Veelken
Principal Investigator Email
stafsecretariaathematologie@lumc.nl
Contact Person Name
Hendrik Veelken
Site Name
Meander Medisch Centrum
Department Name
Internal Disease
Principal Investigator Name
Maarten Corsten
Principal Investigator Email
mf.corsten@meandermc.nl
Contact Person Name
Maarten Corsten
Contact Person Email
mf.corsten@meandermc.nl

Germany

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
72
Number Of Sites
42
Number Of Participants
151

Sites

Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Innere Medizin - Hämatologie und Onkologie
Principal Investigator Name
Maike de Wit
Principal Investigator Email
maike.dewit@vivantes.de
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
SLK-Kliniken Heilbronn GmbH
Principal Investigator Name
Markus Lindauer
Principal Investigator Email
markus.lindauer@slk-kliniken.de
Contact Person Name
Markus Lindauer
Site Name
Klinikum Chemnitz gGmbH
Department Name
Interne Medizin III
Principal Investigator Name
Mathias Hänel
Principal Investigator Email
m.haenel@skc.de
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Muehlenkreiskliniken AöR
Department Name
Universitätsklinik für Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
Principal Investigator Name
Kai Wille
Principal Investigator Email
kai.wille@muehlenkreiskliniken.de
Contact Person Name
Kai Wille
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Hematology, Oncology, Clinical Infectiology and Palliative Medicine
Principal Investigator Name
Silke Schostok
Principal Investigator Email
Silke.Schostok@helios-gesundheit.de
Contact Person Name
Silke Schostok
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Principal Investigator Name
Mark Ringhoffer
Principal Investigator Email
mark.ringhoffer@klinikum-karlsruhe.de
Contact Person Name
Mark Ringhoffer
Site Name
Kath. St. Paulus GmbH
Principal Investigator Name
Eva Schulte
Principal Investigator Email
eva.schulte@joho-dortmund.de
Contact Person Name
Eva Schulte
Contact Person Email
eva.schulte@joho-dortmund.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Medizinische Klinik I
Principal Investigator Name
Maher Hanoun
Principal Investigator Email
Maher.Hanoun@gesundheitnord.de
Contact Person Name
Maher Hanoun
Contact Person Email
Maher.Hanoun@gesundheitnord.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Hämatologie, Onkologie und klinische Immunologie
Principal Investigator Name
Paul Sebastian Jäger
Contact Person Name
Paul Sebastian Jäger
Site Name
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Department Name
Department of Hematologie
Principal Investigator Name
Roland Schroers
Principal Investigator Email
Roland.Schroers@kk-Bochum.de
Contact Person Name
Roland Schroers
Contact Person Email
Roland.Schroers@kk-Bochum.de
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II Hämatologie/Onkologie
Principal Investigator Name
Björn Steffen
Principal Investigator Email
b.steffen@med.uni-frankfurt.de
Contact Person Name
Björn Steffen
Contact Person Email
b.steffen@med.uni-frankfurt.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Medizinische Klinik und Poliklinik
Principal Investigator Name
Franziska Westendorf
Principal Investigator Email
f.westendorf@uke.de
Contact Person Name
Franziska Westendorf
Contact Person Email
f.westendorf@uke.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Jörg Thomas Bittenbring
Principal Investigator Email
Joerg.thomas.bittenbring@uks.eu
Contact Person Name
Jörg Thomas Bittenbring
Site Name
Medical Center - University Of Freiburg
Department Name
Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation Interdisziplinäres Tumorzentrum(ITZ)
Principal Investigator Name
Michael Lübbert
Principal Investigator Email
michael.luebbert@uniklinik-freiburg.de
Contact Person Name
Michael Lübbert
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Universitätsklinik und Poliklinik für Innere Medizin IV (Hämatologie und Onkologie)
Principal Investigator Name
Michael Heuser
Principal Investigator Email
michael.heuser@uk-halle.de
Contact Person Name
Michael Heuser
Contact Person Email
michael.heuser@uk-halle.de
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Klinik für Hämatologie, Onkologie und Zelltherapie
Principal Investigator Name
Enrico Schalk
Principal Investigator Email
enrico.schalk@med.ovgu.de
Contact Person Name
Enrico Schalk
Contact Person Email
enrico.schalk@med.ovgu.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik für Innere Medizin C Hämatologie und Onkologie, Transplantationszentrum, Palliativmedizin
Principal Investigator Name
Jan Krönke
Principal Investigator Email
onkologie@med.uni-greifswald.de
Contact Person Name
Jan Krönke
Site Name
Klinikum Passau Service GmbH
Principal Investigator Name
Thomas Südhoff
Principal Investigator Email
thomas.suedhoff@klinikum-passau.de
Contact Person Name
Thomas Südhoff
Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
Medizinische Klinik A
Principal Investigator Name
Silke Kapp-Schwoerer
Principal Investigator Email
kappschs@klilu.de
Contact Person Name
Silke Kapp-Schwoerer
Contact Person Email
kappschs@klilu.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologoie
Principal Investigator Name
Jörg Westermann
Principal Investigator Email
joerg.westermann@charite.de
Contact Person Name
Jörg Westermann
Contact Person Email
joerg.westermann@charite.de
Site Name
Klinikum Oldenburg AöR
Department Name
Universitätsklinik für Innere Medizin - Onkologie und Hämatologie
Principal Investigator Name
Andreas Voß
Principal Investigator Email
voss.andreas@klinikum-oldenburg.de
Contact Person Name
Andreas Voß
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Christoph Röllig
Principal Investigator Email
Christoph.roellig@ukdd.de
Contact Person Name
Christoph Röllig
Contact Person Email
Christoph.roellig@ukdd.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Principal Investigator Name
Veit Bücklein
Principal Investigator Email
veit.buecklein@med.uni-muenchen.de
Contact Person Name
Veit Bücklein
Site Name
Klinikum Nuernberg
Principal Investigator Name
Kerstin Schäfer-Eckart
Contact Person Name
Kerstin Schäfer-Eckart
Site Name
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinenhilfe gGmbH
Department Name
Medizinische Klinik, Abteilung Hämato-Onkologie
Principal Investigator Name
Jochen Greiner
Principal Investigator Email
greiner@diak-stuttgart.de
Contact Person Name
Jochen Greiner
Contact Person Email
greiner@diak-stuttgart.de
Site Name
Rostock University Medical Center
Department Name
Haematologie, Haemostasiologie, Onkologie, Stammzelltherapie und Palliativmedizin
Principal Investigator Name
Frauke Theis
Principal Investigator Email
frauke.theis@med.uni-rostock.de
Contact Person Name
Frauke Theis
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Klinik für Hämatologie, Onkologie, Stammzelltransplantation und Palliativmedizin
Principal Investigator Name
Jan Schleicher
Principal Investigator Email
j.schleicher@klinikum-stuttgart.de
Contact Person Name
Jan Schleicher
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik V, Hematology, Oncology and Rheumatology
Principal Investigator Name
Tim Sauer
Principal Investigator Email
tim.sauer@med.uni-heidelberg.de
Contact Person Name
Tim Sauer
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik fur Innere Medizin III
Principal Investigator Name
Hendrik Poeck
Principal Investigator Email
hendrik.poeck@ukr.de
Contact Person Name
Hendrik Poeck
Contact Person Email
hendrik.poeck@ukr.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik III
Principal Investigator Name
Lino Teichmann
Principal Investigator Email
lino.teichmann@ukbonn.de
Contact Person Name
Lino Teichmann
Contact Person Email
lino.teichmann@ukbonn.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik für Innere Medizin III
Principal Investigator Name
Katharina Götze
Principal Investigator Email
katharina.goetze@tum.de
Contact Person Name
Katharina Götze
Contact Person Email
katharina.goetze@tum.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Haematologie und Stammzelltransplantation
Principal Investigator Name
Thomas Schroeder
Principal Investigator Email
studienzentrum-haemaSZT@uk-essen.de
Contact Person Name
Thomas Schroeder
Site Name
Asklepios Klinik St George
Department Name
Department Hematology Oncology and Stem cell research
Principal Investigator Name
Ahmet Elmaagacli
Principal Investigator Email
a.elmaagacli@asklepios.com
Contact Person Name
Ahmet Elmaagacli
Contact Person Email
a.elmaagacli@asklepios.com
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Medizinische Klinik und Poliklinik Hämatologie und Medizinische Onkologie
Principal Investigator Name
Michael Kühn
Principal Investigator Email
michael.kuehn@unimedizin-mainz.de
Contact Person Name
Michael Kühn
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Internal Medicine Ill
Principal Investigator Name
Hartmut Döhner
Principal Investigator Email
konstanze.doehner@uniklinik-ulm.de
Contact Person Name
Hartmut Döhner

Sponsor

Primary sponsor

Full Name
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Organisation Type
Patient organisation/association
Country Of Registered Address
Netherlands

Contract research organisations

Name
PPD (UK) Limited
Responsibilities
sponsorDuties codes: 1, 12, 5
Name
Clinigen Clinical Supplies Management
Responsibilities
sponsorDuties code: 14 (clinical supplies management)
Name
4g Clinical LLC
Responsibilities
sponsorDuties code: 3

Third parties

  • {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"laboratory anaylis, biobanking","organisation_type":"Educational Institution"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"laboratory anaylis, biobanking","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 5","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Amsterdam UMC Stichting","duties_or_roles":"laboratory anaylis, biobanking","organisation_type":"Patient organisation/association"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"laboratory anaylis, biobanking","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
JNJ-75276617
Active Substance
BLEXIMENIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Placebo to match bleximenib 50 mg
Modality
Other
Investigational Product Name
placebo to match bleximenib 100 mg
Modality
Other
Combination Treatment
Yes

Related trials

Other published trials that may interest you.