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
14-02-2025
First CTIS Authorization Date
11-07-2025

Trial design

Randomised, ven+aza (venetoclax + azacitidine) as the comparator arm; venetoclax tablets (marketed formulations 50 mg and 100 mg) + azacitidine (azacitidine betapharm 25 mg/ml powder for suspension for injection) — placebo matching bleximenib (matching the 100 mg, 50 mg, 30 mg) used for blinding.-controlled Phase III trial across 107 sites in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
VEN+AZA (venetoclax + azacitidine) as the comparator arm; venetoclax tablets (marketed formulations 50 mg and 100 mg) + azacitidine (Azacitidine betapharm 25 mg/mL powder for suspension for injection) — placebo matching bleximenib (matching the 100 mg, 50 mg, 30 mg) used for blinding.
Biomarker Stratified
True, biomarker: KMT2A rearrangements or NPM1 mutations (strata defined by presence of KMT2A rearrangement or NPM1 mutation)
Target Sample Size
338

Eligibility

Recruits 338 Vulnerable population selected according to CTIS. Only adults (≥18 years of age or legal age of majority in jurisdiction) may be enrolled; informed consent must be provided by the participant (legal adult). Country-specific subject information and informed consent forms are provided (multiple language versions and specific forms for pregnant partners/withdrawal described in submission documents)..

Vulnerable Population
Vulnerable population selected according to CTIS. Only adults (≥18 years of age or legal age of majority in jurisdiction) may be enrolled; informed consent must be provided by the participant (legal adult). Country-specific subject information and informed consent forms are provided (multiple language versions and specific forms for pregnant partners/withdrawal described in submission documents).

Inclusion criteria

  • {"criterion_text":"- 1. Be ≥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. Previously untreated KMT2Ar or NPM1m AML with ≥10% blasts per 2022 ICC criteria. -Participants with KMT2A partial tandem duplications or amplifications are NOT eligible. - Emergency leukapheresis and/or cytoreductive therapy with hydroxyurea and/or to a total of 2 g/m2 cytarabine (cytarabine may be administered over a maximum of 5 days, not to exceed 3 doses) is permitted prior to first dose of study treatment. Note: cytoreductive therapy with cytarabine should not be given until after the screening bone marrow assessment. Leukapheresis and cytarabine must be discontinued 1 day prior to first dose of study treatment.\n- 3. Ineligible for intensive chemotherapy based on the following criteria: ≥75 years of age and ineligible per physician’s discretion, with ECOG performance status of 0-2 ≥18 to <75 years of age with ≥1 of the following comorbidities: ECOG performance status of 2 Severe cardiac disorder (eg, congestive heart failure requiring treatment or chronic stable angina) Severe pulmonary disorder (eg, DLCO ≤ 65% or FEV1 ≤65%) Renal impairment defined as eGFR (MDRD formula) Comorbidity that, in the investigator’s opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care\n- 4. Adequate renal and hepatic functions prior to randomization: -AST and ALT <3 × ULN; for participants with leukemic organ involvement (documented by biopsy or imaging) AST and ALT <5 × ULN is permitted. -Total bilirubin ≤ 3× ULN, unless of non-hepatic origin. If bilirubin rise is due to congenital nonhemolytic hyperbilirubinemia such as Gilbert’s syndrome (in which case conjugated bilirubin needs to be within a clinically acceptable range and total bilirubin ≤3 × ULN). -eGFR (MDRD formula)\n- 5. WBC count < 25 X 10^9/ L"}

Exclusion criteria

  • {"criterion_text":"- 1. Known active leukemic involvement of the CNS\n- 2. History of myelofibrosis\n- 3. Cardiac disease: a. Any 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. QTcF ≥470 msec. Participants with a family history of Long QT syndrome are excluded. For participants with documented wide QRS interval (eg, due to a bundle branch block), alternate methods of calculating a corrected QT interval may be appropriate for eligibility determination if recommended by a consulting cardiologist and approved by the sponsor, provided there is no evidence or history of a repolarization abnormality.\n- 4. Chronic respiratory disease requiring supplemental oxygen\n- 5. Active infection that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or expose the patient to undue risk by participating in the trial; an infection controlled with systemic therapy is allowed."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Dual primary endpoints: CR and OS","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
338
Recruitment Window Months
51
Consent Approach
Informed consent obtained from each participant (participants must be ≥18 years or legal age of majority). Country-specific subject information and informed consent forms (SIS and ICF) are available in multiple languages and include pregnancy/pregnant-partner and withdrawal information; detailed ICF versions provided per Member State in submission documents.

Geography

Total Number Of Sites
107
Total Number Of Participants
246

Austria

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
22-07-2025
Processing Time Days
67
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Medizinische Onkologie und Haematologie
Principal Investigator Name
Sigrid Machherndl-Spandl
Principal Investigator Email
Sigrid.Machherndl-Spandl@ordensklinikum.at
Contact Person Name
Sigrid Machherndl-Spandl
Site Name
Klinik Hietzing
Department Name
5 Medizinische Abteilung Innere Medizin mit Haematologie Onkologie und Palliativstation
Principal Investigator Name
Claudia Rintelen-Denk
Contact Person Name
Claudia Rintelen-Denk
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Innere Med IV Schwerpunkte Haematologie Intern Onkologie, Palliativmedizin, Nephrologie, Dialyse
Principal Investigator Name
Sonja Heibl
Principal Investigator Email
sonja.heibl@klinikum-wegr.at
Contact Person Name
Sonja Heibl
Contact Person Email
sonja.heibl@klinikum-wegr.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitaetsklinik fuer Innere Medizin III, Haematologie Onkologie Rheumtologie Infektiologie
Principal Investigator Name
Michael Leisch
Principal Investigator Email
m.leisch@salk.at
Contact Person Name
Michael Leisch
Contact Person Email
m.leisch@salk.at
Site Name
Medical University Of Vienna
Department Name
Klinische Abteilung fur Hamatologie und Hamostaseologie
Principal Investigator Name
Karoline Gleixner
Principal Investigator Email
karoline.gleixner@meduniwien.ac.at
Contact Person Name
Karoline Gleixner
Site Name
Johannes Kepler University Linz
Department Name
Innere Medizin 3 Haematologie und Internistische Onkologie
Principal Investigator Name
Clemens Schmitt
Principal Investigator Email
Clemens.Schmitt@kepleruniklinikum.at
Contact Person Name
Clemens Schmitt
Site Name
Klinikum (other listed Austrian sites)

Belgium

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
62
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Clinique Saint-Pierre
Department Name
Hematology
Principal Investigator Name
Thierry Connerotte
Principal Investigator Email
thierry.connerotte@cspo.be
Contact Person Name
Thierry Connerotte
Contact Person Email
thierry.connerotte@cspo.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Hematologie
Principal Investigator Name
Eva De Backer
Principal Investigator Email
research.oncologie@uza.be
Contact Person Name
Eva De Backer
Contact Person Email
research.oncologie@uza.be
Site Name
Universiteit Gent
Department Name
Hematology
Principal Investigator Name
Anke Delie
Principal Investigator Email
hematologie@uzgent.be
Contact Person Name
Anke Delie
Contact Person Email
hematologie@uzgent.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Principal Investigator Name
Dries Deeren
Principal Investigator Email
secr.hematologie@azdelta.be
Contact Person Name
Dries Deeren
Contact Person Email
secr.hematologie@azdelta.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
CHU Helora
Department Name
Hematology
Principal Investigator Name
Rahpaël Lattenist
Principal Investigator Email
raphael.lattenist@jolimont.be
Contact Person Name
Rahpaël Lattenist
Contact Person Email
raphael.lattenist@jolimont.be
Site Name
AZ St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Principal Investigator Name
Alexander Schauwvlieghe
Principal Investigator Email
hematologie@azsintjan.be
Contact Person Name
Alexander Schauwvlieghe
Contact Person Email
hematologie@azsintjan.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Hematology
Principal Investigator Name
Griet Swennen
Principal Investigator Email
griet.swennen@zol.be
Contact Person Name
Griet Swennen
Contact Person Email
griet.swennen@zol.be

Czechia

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
62
Number Of Sites
7
Number Of Participants
17

Sites

Site Name
Institute Of Hematology And Blood Transfusion
Department Name
Ambulance
Principal Investigator Name
Jacqueline Soukupova Maaloufova
Principal Investigator Email
Jacqueline.Maaloufova@uhkt.cz
Contact Person Name
Jacqueline Soukupova Maaloufova
Contact Person Email
Jacqueline.Maaloufova@uhkt.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Principal Investigator Name
Barbora Dluhosova
Principal Investigator Email
barbora.dluhosova@osu.cz
Contact Person Name
Barbora Dluhosova
Contact Person Email
barbora.dluhosova@osu.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Interni hematologicka klinika
Principal Investigator Name
Jan Novak
Principal Investigator Email
jan.novak@fnkv.cz
Contact Person Name
Jan Novak
Contact Person Email
jan.novak@fnkv.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interni klinika - klinika hematologie 1.LF a VFN
Principal Investigator Name
Anna Jonasova
Principal Investigator Email
anna.jonasova@vfn.cz
Contact Person Name
Anna Jonasova
Contact Person Email
anna.jonasova@vfn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika
Principal Investigator Name
Jiri Mayer
Principal Investigator Email
mayer.jiri@fnbrno.cz
Contact Person Name
Jiri Mayer
Contact Person Email
mayer.jiri@fnbrno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Interni hematologicka klinika
Principal Investigator Name
Benjamin Visek
Principal Investigator Email
benjamin.visek@fnhk.cz
Contact Person Name
Benjamin Visek
Contact Person Email
benjamin.visek@fnhk.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
Hematologicko-onkologicke oddeleni
Principal Investigator Name
Pavel Jindra
Principal Investigator Email
jindra@fnplzen.cz
Contact Person Name
Pavel Jindra
Contact Person Email
jindra@fnplzen.cz

Denmark

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
59
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Rigshospitalet
Department Name
Dept. of Hematology
Principal Investigator Name
Anne Louise Toelboell Soerensen
Principal Investigator Email
anne.louise.toelboell.soerensen@regionh.dk
Contact Person Name
Anne Louise Toelboell Soerensen
Site Name
Region Sjaelland
Department Name
Dept. of Hematology
Principal Investigator Name
Jack Maibom
Principal Investigator Email
jmai@regionsjaelland.dk
Contact Person Name
Jack Maibom
Contact Person Email
jmai@regionsjaelland.dk
Site Name
Aalborg University Hospital
Department Name
Dept. of Hematology
Principal Investigator Name
Tove-Christina Choe Kristensen
Principal Investigator Email
tcck@rn.dk
Contact Person Name
Tove-Christina Choe Kristensen
Contact Person Email
tcck@rn.dk
Site Name
Odense University Hospital
Department Name
Dept of hematology
Principal Investigator Name
Claus Werenberg Marcher
Principal Investigator Email
claus.marcher@rsyd.dk
Contact Person Name
Claus Werenberg Marcher
Contact Person Email
claus.marcher@rsyd.dk

France

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
11-07-2025
Processing Time Days
46
Number Of Sites
13
Number Of Participants
27

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hematology
Principal Investigator Name
Thomas CLUZEAU
Principal Investigator Email
cluzeau.t@chu-nice.fr
Contact Person Name
Thomas CLUZEAU
Contact Person Email
cluzeau.t@chu-nice.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Hematology
Principal Investigator Name
Mathilde HUNAULT
Principal Investigator Email
mahunault@chu-angers.fr
Contact Person Name
Mathilde HUNAULT
Contact Person Email
mahunault@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hematology
Principal Investigator Name
Jean-Baptiste MEAR
Principal Investigator Email
jean-baptiste.mear@chu-rennes.fr
Contact Person Name
Jean-Baptiste MEAR
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hematology
Principal Investigator Name
Julie BARDOL
Principal Investigator Email
j-bardol@chu-montpellier.fr
Contact Person Name
Julie BARDOL
Contact Person Email
j-bardol@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Senior Hematology
Principal Investigator Name
Lionel ADES
Principal Investigator Email
lionel.ades@aphp.fr
Contact Person Name
Lionel ADES
Contact Person Email
lionel.ades@aphp.fr
Site Name
Institut Gustave Roussy
Department Name
Hematology
Principal Investigator Name
Stéphane DE BOTTON
Principal Investigator Email
stephane.debotton@gustaveroussy.fr
Contact Person Name
Stéphane DE BOTTON
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hematology and cellular therapy department and oncology department
Principal Investigator Name
Aurélie RAVINET
Principal Investigator Email
aravinet@chu-clermontferrand.fr
Contact Person Name
Aurélie RAVINET
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Onco-Hematology
Principal Investigator Name
Laurent PASCAL
Principal Investigator Email
pascal.laurent@ghicl.net
Contact Person Name
Laurent PASCAL
Contact Person Email
pascal.laurent@ghicl.net
Site Name
CHRU De Nancy
Department Name
Hematology
Principal Investigator Name
Gabrielle Roth Guepin
Principal Investigator Email
g.roth-guepin@chru-nancy.fr
Contact Person Name
Gabrielle Roth Guepin
Contact Person Email
g.roth-guepin@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology
Principal Investigator Name
Christian RECHER
Principal Investigator Email
recher.christian@iuct-oncopole.fr
Contact Person Name
Christian RECHER
Site Name
Hospices Civils De Lyon
Department Name
Hematology
Principal Investigator Name
Maël HEIBLIG
Principal Investigator Email
mael.heiblig@chu-lyon.fr
Contact Person Name
Maël HEIBLIG
Contact Person Email
mael.heiblig@chu-lyon.fr
Site Name
Institut Paoli Calmettes
Department Name
Hematology
Principal Investigator Name
Sylvain GARCIAZ
Principal Investigator Email
GARCIAZS@ipc.unicancer.fr
Contact Person Name
Sylvain GARCIAZ
Contact Person Email
GARCIAZS@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Hematology
Principal Investigator Name
Anne QUINQUENEL
Principal Investigator Email
aquinquenel@chu-reims.fr
Contact Person Name
Anne QUINQUENEL
Contact Person Email
aquinquenel@chu-reims.fr

Germany

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
59
Number Of Sites
13
Number Of Participants
26

Sites

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
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
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
Principal Investigator Name
Klaus Metzeler
Principal Investigator Email
klaus.metzeler@medizin.uni-leipzig.de
Contact Person Name
Klaus Metzeler
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Hämatologie & medizinische Onkologie
Principal Investigator Name
Raphael Koch
Principal Investigator Email
raphael.koch@med.uni-goettingen.de
Contact Person Name
Raphael Koch
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II
Principal Investigator Name
Hermann Einsele
Principal Investigator Email
einsele_h@ukw.de
Contact Person Name
Hermann Einsele
Contact Person Email
einsele_h@ukw.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Medizinische Klinik III
Principal Investigator Name
Christoph Schmid
Principal Investigator Email
christoph.schmid@uk-augsburg.de
Contact Person Name
Christoph Schmid
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Principal Investigator Name
Joe Sebastian
Principal Investigator Email
joe.sebastian@uk-essen.de
Contact Person Name
Joe Sebastian
Contact Person Email
joe.sebastian@uk-essen.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik V
Principal Investigator Name
Tim Sauer
Principal Investigator Email
tim.sauer@med.uni-heidelberg.de
Contact Person Name
Tim Sauer
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik I
Principal Investigator Name
Christoph Roellig
Principal Investigator Email
christoph.roellig@uniklinikum-dresden.de
Contact Person Name
Christoph Roellig
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II
Principal Investigator Name
Anjali Cremer
Principal Investigator Email
anjali.cremer@kgu.de
Contact Person Name
Anjali Cremer
Contact Person Email
anjali.cremer@kgu.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik fuer Innere Medizin I
Principal Investigator Name
Michael Luebbert
Principal Investigator Email
michael.luebbert@uniklinik-freiburg.de
Contact Person Name
Michael Luebbert
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Lars Fransecky
Principal Investigator Email
Lars.Fransecky@uksh.de
Contact Person Name
Lars Fransecky
Contact Person Email
Lars.Fransecky@uksh.de
Site Name
University Hospital Cologne AöR
Department Name
Innere Medizin I
Principal Investigator Name
Lukas Frenzel
Principal Investigator Email
lukas.frenzel@uk-koeln.de
Contact Person Name
Lukas Frenzel
Contact Person Email
lukas.frenzel@uk-koeln.de

Greece

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
65
Number Of Sites
7
Number Of Participants
17

Sites

Site Name
University General Hospital Of Alexandroupoli
Department Name
Hematology Clinic
Principal Investigator Name
Ioannis Kotsianidis
Principal Investigator Email
jankots@yahoo.gr
Contact Person Name
Ioannis Kotsianidis
Contact Person Email
jankots@yahoo.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
Hematology Department
Principal Investigator Name
Maria Papaioannou
Principal Investigator Email
marygpap@gmail.com
Contact Person Name
Maria Papaioannou
Contact Person Email
marygpap@gmail.com
Site Name
University General Hospital Of Ioannina
Department Name
Haematology Department
Principal Investigator Name
Eleftheria Hatzimichael
Principal Investigator Email
ehatzim@uoi.gr
Contact Person Name
Eleftheria Hatzimichael
Contact Person Email
ehatzim@uoi.gr
Site Name
Evaggelismos Hospital
Department Name
Hematology and Lymphoma Clinic, Bone Marrow Transplant Unit
Principal Investigator Name
Maria Pagoni
Principal Investigator Email
marianpagoni@yahoo.com
Contact Person Name
Maria Pagoni
Contact Person Email
marianpagoni@yahoo.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department
Principal Investigator Name
Elissavet-Chrisavgi Lalagianni
Principal Investigator Email
luizana6@gmail.com
Contact Person Name
Elissavet-Chrisavgi Lalagianni
Contact Person Email
luizana6@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Hematology Clinic, Department of Internal Medicine
Principal Investigator Name
Alexandros Spyridonidis
Principal Investigator Email
spyridonidis@upatras.gr
Contact Person Name
Alexandros Spyridonidis
Contact Person Email
spyridonidis@upatras.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Department of Internal Medicine - Propaedeutic
Principal Investigator Name
Panagiotis Tsirigotis
Principal Investigator Email
pantsir@med.uoa.gr
Contact Person Name
Panagiotis Tsirigotis
Contact Person Email
pantsir@med.uoa.gr

Poland

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
70
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Hematologii
Principal Investigator Name
Marta Sobas
Principal Investigator Email
marta.sobas@gmail.com
Contact Person Name
Marta Sobas
Contact Person Email
marta.sobas@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Hematologii,Chorob Wewnetrznych i Angiologii
Principal Investigator Name
Jaroslaw Piszcz
Principal Investigator Email
hem@umb.edu.pl
Contact Person Name
Jaroslaw Piszcz
Contact Person Email
hem@umb.edu.pl
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Hematologii i Transplantacji Szpiku
Principal Investigator Name
Pawel Steckiewicz
Principal Investigator Email
p.steckiewicz@gmail.com
Contact Person Name
Pawel Steckiewicz
Contact Person Email
p.steckiewicz@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii, Transplantologii i Terapii Komórkowych
Principal Investigator Name
Aleksandra Wadolowska
Principal Investigator Email
hematologia@uck.gda.pl
Contact Person Name
Aleksandra Wadolowska
Contact Person Email
hematologia@uck.gda.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddzial Hematologii i Transplantologii i Chorob Wewnetrznych – 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 Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz_wrobel@wp.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz_wrobel@wp.pl

Italy

Earliest CTIS Part Ii Submission Date
20-05-2025
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
58
Number Of Sites
13
Number Of Participants
35

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dipartmento di Ematologia e Oncologia
Principal Investigator Name
Ernesta Audisio
Principal Investigator Email
eaudisio@cittadellasalute.to.it
Contact Person Name
Ernesta Audisio
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Ematologia, Dipartimento Scienze Mediche e Chirurgiche
Principal Investigator Name
Cristina Papayannidis
Principal Investigator Email
cristina.papayannidis@unibo.it
Contact Person Name
Cristina Papayannidis
Contact Person Email
cristina.papayannidis@unibo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Ematologia
Principal Investigator Name
Matteo Della Porta
Principal Investigator Email
matteo.della_porta@hunimed.eu
Contact Person Name
Matteo Della Porta
Contact Person Email
matteo.della_porta@hunimed.eu
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Ematologia
Principal Investigator Name
Marianna Norata
Principal Investigator Email
marianna.norata@irst.emr.it
Contact Person Name
Marianna Norata
Contact Person Email
marianna.norata@irst.emr.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Ematologia
Principal Investigator Name
Paola Martelli
Principal Investigator Email
maria.martelli@unipg.it
Contact Person Name
Paola Martelli
Contact Person Email
maria.martelli@unipg.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Dip Ematologia, Oncologia e Medicina Molecolare - SC Ematologia
Principal Investigator Name
Roberto Cairoli
Principal Investigator Email
roberto.cairoli@ospedaleniguarda.it
Contact Person Name
Roberto Cairoli
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dipartimento Area Medica, S.C. Ematologia
Principal Investigator Name
Nicola Fracchiolla
Principal Investigator Email
nicola.fracchiolla@policlinico.mi.it
Contact Person Name
Nicola Fracchiolla
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O.C Ematologia
Principal Investigator Name
Erika Borlenghi
Principal Investigator Email
erika.borlenghi@asst-spedalicivili.it
Contact Person Name
Erika Borlenghi
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
UOC Ematologia
Principal Investigator Name
Caterina Alati
Principal Investigator Email
caterina.alati@gmail.com
Contact Person Name
Caterina Alati
Contact Person Email
caterina.alati@gmail.com
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncoematologia, U.O. Ematologia
Principal Investigator Name
Giovanni Marconi
Principal Investigator Email
giovanni.marconi@studio.unibo.it
Contact Person Name
Giovanni Marconi
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
Onco-ematologia, UOC Ematologia e Centro Trapianti
Principal Investigator Name
Alessandro Isidori
Principal Investigator Email
alessandro.isidori@sanita.marche.it
Contact Person Name
Alessandro Isidori
Site Name
Casa Sollievo Della Sofferenza
Department Name
UOC di Ematologia e Trapianto di Cellule Staminali Emopoietiche
Principal Investigator Name
Michele Carella
Principal Investigator Email
am.carella@operapadrepio.it
Contact Person Name
Michele Carella
Contact Person Email
am.carella@operapadrepio.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Ematologia
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
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Ematologia I
Principal Investigator Name
Patrizia Zappasodi
Principal Investigator Email
p.zappasodi@smatteo.pv.it
Contact Person Name
Patrizia Zappasodi
Contact Person Email
p.zappasodi@smatteo.pv.it

Portugal

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
62
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Hematologia
Principal Investigator Name
Ana Espirito Santo
Principal Investigator Email
ana.esanto@ipoporto.min-saude.pt
Contact Person Name
Ana Espirito Santo
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Hematologia
Principal Investigator Name
Claudia Casais
Principal Investigator Email
ccasais.hematologia@chporto.min-saude.pt
Contact Person Name
Claudia Casais
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Hematologia
Principal Investigator Name
Patricia Ribeiro
Principal Investigator Email
patricia.m.ribeiro@ulssjose.min-saude.pt
Contact Person Name
Patricia Ribeiro
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Hematologia
Principal Investigator Name
Joana Brioso Infante
Principal Investigator Email
joana.infante@ulssm.min-saude.pt
Contact Person Name
Joana Brioso Infante
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Hematologia
Principal Investigator Name
Eliana Aguiar
Principal Investigator Email
eliana.aguiar@ulssjoao.min-saude.pt
Contact Person Name
Eliana Aguiar

Spain

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
16-07-2025
Processing Time Days
42
Number Of Sites
16
Number Of Participants
34

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Principal Investigator Name
Guadalupe Onate
Principal Investigator Email
gonate@santpau.cat
Contact Person Name
Guadalupe Onate
Contact Person Email
gonate@santpau.cat
Site Name
Hospital San Pedro De Alcantara
Department Name
Hematology
Principal Investigator Name
Juan Miguel Bergua Burgues
Principal Investigator Email
jmberguaburg@gmail.com
Contact Person Name
Juan Miguel Bergua Burgues
Contact Person Email
jmberguaburg@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Olga Salamero Garcia
Principal Investigator Email
osalamero@vhio.net
Contact Person Name
Olga Salamero Garcia
Contact Person Email
osalamero@vhio.net
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Guillermo Martin Sanchez
Principal Investigator Email
guillermo.martin@scsalud.es
Contact Person Name
Guillermo Martin Sanchez
Contact Person Email
guillermo.martin@scsalud.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Hematology
Principal Investigator Name
Virginia Pradillo Fernandez
Principal Investigator Email
virginiapradillo@gmail.com
Contact Person Name
Virginia Pradillo Fernandez
Contact Person Email
virginiapradillo@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Hematology
Principal Investigator Name
Victor Noriega Concepcion
Principal Investigator Email
victor.noriega.concepcion@sergas.es
Contact Person Name
Victor Noriega Concepcion
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Principal Investigator Name
Jordi Esteve Reyner
Principal Investigator Email
jesteve@clinic.cat
Contact Person Name
Jordi Esteve Reyner
Contact Person Email
jesteve@clinic.cat
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Hematology
Principal Investigator Name
Ana Alfonso Pierola
Principal Investigator Email
aalfonso@unav.es
Contact Person Name
Ana Alfonso Pierola
Contact Person Email
aalfonso@unav.es
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Maria Belen Vidriales Vicente
Principal Investigator Email
mbvidri@usal.es
Contact Person Name
Maria Belen Vidriales Vicente
Contact Person Email
mbvidri@usal.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Pilar Herrera Puente
Principal Investigator Email
pherrera.hrc@gmail.com
Contact Person Name
Pilar Herrera Puente
Contact Person Email
pherrera.hrc@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Montserrat Arnan
Principal Investigator Email
marnan@iconcologia.net
Contact Person Name
Montserrat Arnan
Contact Person Email
marnan@iconcologia.net
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Hematology
Principal Investigator Name
Ana Alfonso Pierola
Principal Investigator Email
aalfonso@unav.es
Contact Person Name
Ana Alfonso Pierola
Contact Person Email
aalfonso@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Maria Belen Calbacho Robles
Principal Investigator Email
mcalbachorobles@gmail.com
Contact Person Name
Maria Belen Calbacho Robles
Contact Person Email
mcalbachorobles@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Laura Torres Miñana
Principal Investigator Email
laura_torres@iislafe.es
Contact Person Name
Laura Torres Miñana
Contact Person Email
laura_torres@iislafe.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Eduardo Rodriguez Arboli
Principal Investigator Email
edurodarb@gmail.com
Contact Person Name
Eduardo Rodriguez Arboli
Contact Person Email
edurodarb@gmail.com
Site Name
Hospital De Jerez De La Frontera
Department Name
Hematology
Principal Investigator Name
Patricia Jimenez Guerrero
Contact Person Name
Patricia Jimenez Guerrero

Hungary

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
22-07-2025
Processing Time Days
60
Number Of Sites
8
Number Of Participants
14

Sites

Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Principal Investigator Name
Arpad Batai
Principal Investigator Email
batai.arpad@dpckorhaz.hu
Contact Person Name
Arpad Batai
Contact Person Email
batai.arpad@dpckorhaz.hu
Site Name
University Of Szeged
Department Name
II. Belgyógyászati Klinika és Kardiológiai Központ
Principal Investigator Name
Zita Borbenyi
Principal Investigator Email
borbenyizita@gmail.com
Contact Person Name
Zita Borbenyi
Contact Person Email
borbenyizita@gmail.com
Site Name
Semmelweis University
Department Name
II. Belgyogyaszat Hematologia
Principal Investigator Name
Zsolt Nagy
Principal Investigator Email
nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name
Zsolt Nagy
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
Principal Investigator Name
Laszlo Rejto
Principal Investigator Email
lrejto@med.unideb.hu
Contact Person Name
Laszlo Rejto
Contact Person Email
lrejto@med.unideb.hu
Site Name
University Of Debrecen
Department Name
Debreceni Egyetem Klinikai Kozpont, Hematologia
Principal Investigator Name
Arpad Illes
Principal Investigator Email
illes.arpad@med.unideb.hu
Contact Person Name
Arpad Illes
Contact Person Email
illes.arpad@med.unideb.hu
Site Name
University Of Pecs
Department Name
Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
Principal Investigator Name
Hussain Alizadeh
Principal Investigator Email
alizadeh.hussain@pte.hu
Contact Person Name
Hussain Alizadeh
Contact Person Email
alizadeh.hussain@pte.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz, II Belgyogyaszat Haematologia
Principal Investigator Name
Zsolt Lazar
Principal Investigator Email
lazarzsolt1982@gmail.com
Contact Person Name
Zsolt Lazar
Contact Person Email
lazarzsolt1982@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Ppd Inc.
Responsibilities
code 4
Name
Pharma Bio-Research Group
Responsibilities
code 4

Third parties

  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Transportation reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA Vendor; code 3; code 6; code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Malaysia","full_name":"Hematogenix","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-75276617
Active Substance
BLEXIMENIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Investigational (prodAuthStatus: 1 in CTIS product record)
Dose Levels
30 mg | 50 mg | 100 mg (matching the 30 mg (G031), 50 mg (G029), 100 mg (G030))
Investigational Product Name
Venclyxto 100 mg film-coated tablets
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Marketed (marketingAuthNumber: EU/1/16/1138/007)
Dose Levels
100 mg (also available 50 mg formulation in trial)
Investigational Product Name
Venclyxto 50 mg film-coated tablets
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Marketed (marketingAuthNumber: EU/1/16/1138/004 or other EU MA entries)
Dose Levels
50 mg
Investigational Product Name
Azacitidine betapharm 25 mg/mL powder for suspension for injection
Active Substance
AZACITIDINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketed (marketingAuthNumber: EU/1/19/1416/001)
Investigational Product Name
matching the 100 mg (G030) (placebo)
Modality
Other
Authorisation Status
Placebo (not an active medicinal product)
Dose Levels
100 mg (matching placebo)
Investigational Product Name
matching the 50 mg (G029) (placebo)
Modality
Other
Authorisation Status
Placebo (not an active medicinal product)
Dose Levels
50 mg (matching placebo)
Investigational Product Name
matching the 30 mg (G031) (placebo)
Modality
Other
Authorisation Status
Placebo (not an active medicinal product)
Dose Levels
30 mg (matching placebo)
Combination Treatment
Yes

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