Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
1,027
Countries
14
Sites
137
Acute Myeloid Leukemia
To assess if treatment with bleximenib, as compared with placebo, in combination with remission induction and consolidation chemotherapy, followed by maintenance therapy, prolongs EFS in adult participants with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy.
Key facts
- Sponsor
- Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Janssen Research & Development, LLC
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy, Others, Pharmacokinetic
To assess if treatment with bleximenib, as compared with placebo, in combination with remission induction and consolidation chemotherapy, followed by maintenance therapy, prolongs EFS in adult participants with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy.
Conditions and MedDRA coding
Acute Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1. ≥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.
- 2. New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.
- 3. Considered eligible for intensive chemotherapy.
- 4. WHO/ECOG performance status ≤2.
- 5. Adequate renal and hepatic functions prior to randomization:
- 6. White blood cell (WBC) count <25 × 109/L.
Exclusion criteria 6
- 3. Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents
- 4. Known active leukemic involvement of the central nervous system (CNS).
- 5. Recipient of solid organ transplant.
- 6. 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. QTc 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. Previously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg/m2.
- 7 Chronic respiratory disease requiring supplemental oxygen.
- 8. Active 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 and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11370369 · Product
- Active substance
- Bleximenib
- Substance synonyms
- N-ethyl-5-fluoro-N-isopropyl-2-[[5-(2-[(3R)-6-[(2-methoxyethyl)(methyl)amino]-2-methylhexan-3-yl]-2,6-diazaspiro[3.4]octan-6-yl)-1,2,4-triazin-6-yl]oxy]benzamide, JNJ-75276617
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11370368 · Product
- Active substance
- Bleximenib
- Substance synonyms
- N-ethyl-5-fluoro-N-isopropyl-2-[[5-(2-[(3R)-6-[(2-methoxyethyl)(methyl)amino]-2-methylhexan-3-yl]-2,6-diazaspiro[3.4]octan-6-yl)-1,2,4-triazin-6-yl]oxy]benzamide, JNJ-75276617
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
Placebo to match bleximenib 50 mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
placebo to match bleximenib 100 mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
- Sponsor organisation
- Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
- Contact name
- Prof. Dr. H.G.P. Raaijmakers
Public contact point
- Organisation
- Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
- Contact name
- HOVON
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Clinigen Clinical Supplies Management ORG-100034422
|
Mont-Saint-Guibert, Belgium | Code 14 |
| Medizinische Hochschule Hannover ORG-100024473
|
Hanover, Germany | Other |
| Universitaetsklinikum Ulm AöR ORG-100006370
|
Ulm, Germany | Other |
| PPD (UK) Limited ORG-100022673
|
Cambridge, United Kingdom | On site monitoring, Code 12, Code 5 |
| Amsterdam UMC Stichting ORG-100008355
|
Amsterdam, Netherlands | Other |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) ORG-100008976
|
Rotterdam, Netherlands | Other |
Locations
14 EU/EEA countries · 137 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 6 | 3 |
| Belgium | Authorised, recruiting | 45 | 14 |
| Denmark | Authorised, recruitment pending | 6 | 4 |
| Estonia | Authorised, recruitment pending | 6 | 2 |
| Finland | Authorised, recruitment pending | 15 | 5 |
| Germany | Ongoing, recruiting | 151 | 42 |
| Ireland | Authorised, recruitment pending | 12 | 6 |
| Italy | Authorised, recruitment pending | 45 | 13 |
| Lithuania | Authorised, recruitment pending | 3 | 1 |
| Netherlands | Ongoing, recruiting | 69 | 18 |
| Norway | Authorised, recruitment pending | 12 | 5 |
| Poland | Authorised, recruitment pending | 15 | 7 |
| Spain | Authorised, recruitment pending | 26 | 13 |
| Sweden | Authorised, recruitment pending | 12 | 4 |
| Rest of world
China, Japan, Switzerland, Australia, New Zealand, Korea, Republic of, United States
|
— | 604 | — |
Investigational sites
Ordensklinikum Linz GmbH
Interne 1 - Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie, Fadingerstrasse 1, 4020, Linz
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
3.Medizinische Abteilung, Heinrich-Collin-Strasse 30, Penzing, Vienna
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Interne E am LKH Rankweil, Carinagasse 47, 6800, Feldkirch
Jessa Ziekenhuis
Hematology, Stadsomvaart 11, 3500, Hasselt
Ziekenhuis Aan De Stroom
Hematology, Kempenstraat 100, 2030, Antwerp
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
CHC MontLegia
Hemato-oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Grand Hopital De Charleroi
Oncology & hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Centre hospitalier universitaire de Liege
Hematology, Avenue De L'Hopital 1, 4000, Liege
CHU Helora
Hematology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Cliniques Universitaires Saint-Luc
Hematology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Hematology, Mijlenmeersstraat 90, 1070, Anderlecht
Ziekenhuis Geel
Hematology, J-B Stessensstraat 2, 2440, Geel
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Antwerpen
Hematology, Drie Eikenstraat 655, 2650, Edegem
Aalborg University Hospital
Hematology, Hobrovej 18-22, 9000, Aalborg
Odense University Hospital
Hematology, J. B. Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
North Estonia Medical Centre Foundation
Haematology and Oncology Centre, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Tartu University Hospital
Oncology Clinic, L. Puusepa Tn 1a, 50406, Tartu Linn
Pohjois-Savon hyvinvointialue
Department of Hematology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
HUS-yhtymae
Department of Hematology, Haartmaninkatu 4, 00290, Helsinki
Pohjois-Pohjanmaan hyvinvointialue
Department of Oncology/ Hematology, Kajaanintie 50, 90220, Oulu
Varsinais-Suomen hyvinvointialue
Department of Clinical Haematology and Stem Cell Transplant Unit, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
Department of Hematology, Elamanaukio 2, 33520, Tampere
Kath. St. Paulus GmbH
N/A, Johannesstrasse 9-17, Mitte, Dortmund
Universitaetsklinikum Ulm AöR
Department of Internal Medicine Ill, Albert-Einstein-Allee 23, Eselsberg, Ulm
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinenhilfe gGmbH
Medizinische Klinik, Abteilung Hämato-Onkologie, Rosenbergstrasse 38, West, Stuttgart
Universitaetsklinikum Essen AöR
Klinik für Haematologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Klinik für Hämatologie, Onkologie, Stammzelltransplantation und Palliativmedizin, Kriegsbergstrasse 60, Mitte, Stuttgart
Medizinische Hochschule Hannover
Klinik für Haematologie, Haemostasiologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum Oldenburg AöR
Universitätsklinik für Innere Medizin - Onkologie und Hämatologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Rostock University Medical Center
Haematologie, Haemostasiologie, Onkologie, Stammzelltherapie und Palliativmedizin, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Otto Von Guericke Universitaet Magdeburg
Klinik für Hämatologie, Onkologie und Zelltherapie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Klinikum Nuernberg
N/A, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Staedtisches Klinikum Braunschweig gGmbH
Medizinische Klinik III, Celler Strasse 38, 38114, Brunswick
Universitaet Des Saarlandes
Klinik für Innere Medizin I, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Bonn AöR
Medizinische Klinik III, Venusberg-Campus 1, Venusberg, Bonn
Klinikum Passau Service GmbH
N/A, Innstrasse 76, Haidenhof-Sued, Passau
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Medizinische Klinik A, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Department of Hematologie, In Der Schornau 23-25, Langendreer, Bochum
Gesundheit Nord gGmbH Klinikverbund Bremen
Medizinische Klinik I, St.-Juergen-Strasse 1, Hulsberg, Bremen
Helios Universitaetsklinikum Wuppertal
Hematology, Oncology, Clinical Infectiology and Palliative Medicine, Heusnerstrasse 40, Barmen, Wuppertal
Philipps-Universitaet Marburg
Haematologie, Onkologie, Immunologie, Baldingerstrasse, 35043, Marburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Medizinische Klinik und Poliklinik Hämatologie und Medizinische Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz
Asklepios Klinik St George
Department Hematology Oncology and Stem cell research, Lohmuehlenstrasse 5, St. Georg, Hamburg
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik fur Innere Medizin III, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Erlangen AöR
N/A, Ulmenweg 18, Innenstadt, Erlangen
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologoie, Hindenburgdamm 30, Lichterfelde, Berlin
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Medical Center Hamburg-Eppendorf
Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Martin-Luther-Universitaet Halle-Wittenberg
Universitätsklinik und Poliklinik für Innere Medizin IV (Hämatologie und Onkologie), Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Medical Center - University Of Freiburg
Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation Interdisziplinäres Tumorzentrum(ITZ), Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik V, Hematology, Oncology and Rheumatology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Staedtisches Klinikum Karlsruhe gGmbH
Medizinische Klinik III, Moltkestrasse 90, Weststadt, Karlsruhe
Universitaetsmedizin Greifswald KöR
Klinik für Innere Medizin C Hämatologie und Onkologie, Transplantationszentrum, Palliativmedizin, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Klinikum Chemnitz gGmbH
Interne Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II, Am Klinikum 1, Lobeda, Jena
Goethe University Frankfurt
Medizinische Klinik II Hämatologie/Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik für Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Duesseldorf AöR
Klinik für Hämatologie, Onkologie und klinische Immunologie, Moorenstrasse 5, Bilk, Duesseldorf
SLK-Kliniken Heilbronn GmbH
N/A, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Pauwelsstrasse 30, 52074, Aachen
Vivantes Netzwerk fuer Gesundheit GmbH
Innere Medizin - Hämatologie und Onkologie, Rudower Strasse 48, Buckow, Berlin
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologoie, Augustenburger Platz 1, Wedding, Berlin
Muehlenkreiskliniken AöR
Universitätsklinik für Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin, Hans-Nolte-Strasse 1, Haeverstaedt, Minden
Beaumont Hospital
Haematology, Beaumont Road, Beaumont, Dublin 9
Cork University Hospital
Haematology, Wilton, T12 DC4A, Cork
St James's Hospital
Haematology, James's Street, D08 NHY1, Dublin 8
St Vincent's University Hospital
Haematology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Mater Misericordiae University Hospital
Haematology, Eccles Street, D07 R2WY, Dublin 7
University Hospital Galway
Haematology, Newcastle Road, H91 YR71, Galway
Azienda Ospedaliero Universitaria Delle Marche
Medicina Interna, Via Conca 71, 60126, Ancona
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department of Hematology and Oncology, Piazza Oms 1, 24127, Bergamo
Istituto Oncologico Veneto
UOC Oncoematologia, Via Dei Carpani 16/z, 31033, Castelfranco Veneto
Azienda Ospedaliero Universitaria Careggi
Department of Experimental and Clinical Medicine, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Ospedale Policlinico San Martino
Hematology and Cell Therapy, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dipartimento Area Medica -S.C. EMATOLOGIA, Via Francesco Sforza 35, 20122, Milan
ASST Grande Ospedale Metropolitano Niguarda
S. C. Hematology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
U.O.C. Oncoematologia, Via Trabucco 180, 90146, Palermo
Hospital Santa Maria Della Misericordia
Department of Medicine and Surgery, Hematology Unit, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Sanitaria Locale Di Pescara
Dipartimento oncologico-ematologico, Via Renato Paolini 47, 65124, Pescara
Azienda Unita Sanitaria Locale Della Romagna
Oncology and Hematology Department, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department of Translational and Precision Medicine, Viale Del Policlinico 155, 00161, Rome
Casa Sollievo Della Sofferenza
Hematology Dept and Bone Marrow Transplantation, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Vilniaus universiteto ligonine Santaros klinikos VšĮ
N/A, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Albert Schweitzer Ziekenhuis
Hematology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Isala Klinieken Stichting
Internal Medicine, Dokter Van Heesweg 2, 8025 AB, Zwolle
Radboud universitair medisch centrum Stichting
Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Sint Antonius Ziekenhuis Stichting
Internal Medicine, Koekoekslaan 1, 3435 CM, Nieuwegein
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Jeroen Bosch Ziekenhuis Stichting
Internal Medicine, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Maxima Medisch Centrum
Hematology, Ds Theodor Fliednerstraat 1, 5631 BM, Eindhoven
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amphia Hospital
Internal Medicine, Molengracht 21, 4818 CK, Breda
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Frisius MC
Oncology Center Leeuwarden, Henri Dunantweg 2, 8934 AD, Leeuwarden
Rijnstate Ziekenhuis Stichting
Hematology, Wagnerlaan 55, 6815 AD, Arnhem
Academisch Ziekenhuis Maastricht
Hematology, P Debyelaan 25, 6229 HX, Maastricht
Haga Hospital
Hematology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Leids Universitair Medisch Centrum (LUMC)
Department of Hematology, Albinusdreef 2, 2333 ZA, Leiden
Stichting OLVG
Internal Disease, Oosterpark 9, 1091 AC, Amsterdam
Meander Medisch Centrum
Internal Disease, Maatweg 3, 3813 TZ, Amersfoort
St. Olavs Hospital HF
Dept. Of Hematology, Prinsesse Kristinas Gate 3, 7030, Trondheim
Oslo Universitetssykehus HF
Dept. of Hematology, Sognsvannsveien 20, 0372, Oslo
Universitetssykehuset Nord-Norge HF
Department of Blood and Endocrinology, Hansine Hansens Veg 67, 9019, Tromsoe
Helse Stavanger HF
Dept. Of Hematology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Helse Bergen HF
Dept. of Hematology, Jonas Lies Vei 65, 5021, Bergen
Samodzielny Publiczny Szpital Kliniczny im. A. Mielęckiego ŚUM w Katowicach
Oddział Hematologii i Transplantacji Szpiku, ul. Dąbrowskiego 25, 40-032, Katowice
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii i Terapii komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Hematologii, Chorób Wewnętrznych i Angiologii z Pododdziałem Transplantacji Komórek K., Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Instytut Hematologii I Transfuzjologii
Klinika Hematologi, Ul. Indiry Gandhi 14, 02-776, Warsaw
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Centralny Szpital kliniczny, Klinika Hematologii, Transplantologii i Chorób Wewnętrznych, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematologii i Transplantologii i Chorób Wewnętrznych – Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Fundacio Assistencial De Mutua De Terrassa Fpc
Haematology, Calle De San Antonio No 32, 08221, Terrassa
Hospital Del Mar
Haematology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Institut Catala D'oncologia
Haematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
University Hospital Son Espases
Haematology, Carretera Valldemossa 79, 07120, Palma
Institut Catala D'oncologia
Haematology, Avinguda De Franca S/n, 17007, Girona
Hospital Clinico Universitario De Valencia
Haematology, Avenida Blasco Ibanez 17, 46010, Valencia
Institut Catala D'oncologia
Haematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Haematology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitari Joan XXIII De Tarragona
Haematology, Calle Del Doctor Mallafre Guasch 4, 43005, Tarragona
Hospital General Universitario Gregorio Maranon
Haematology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Clinic De Barcelona
Haematology, Calle Villarroel 170, 08036, Barcelona
Hospital De La Santa Creu I Sant Pau
Haematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Son Llatzer
Haematology, Carretera De Manacor Km 4, 07198, Palma
Karolinska University Hospital
Hematologi, Halsovagen, Flemingsberg, Huddinge
Uppsala University Hospital
Hematologavdelning 101 A, Akademiska Sjukhuset, 751 85, Uppsala
Region Skane Skanes Universitetssjukhus
VO Hematologi, onkologi och strålningsfysik, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Sektionen för Hematologi och koagulation, Bla Straket 5, Goteborgs Annedal, Goteborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-04-29 | ||||
| Germany | 2026-02-27 | 2026-03-01 | |||
| Netherlands | 2026-01-27 | 2026-03-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 99 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 HO181_AMLSG37-25_protocol 2025-522767-15 Public | 2 |
| Protocol (for publication) | D4_HO181 PF_QoL Questionnaire 1 statement_2025-522767-15 | 1 |
| Protocol (for publication) | D4_HO181 PF_QoL Questionnaire 1_ statement_2025-522767-15 | 1 |
| Protocol (for publication) | D4_HO181 PF_QoL Questionnaire 2 statement_2025-522767-15 | 1 |
| Protocol (for publication) | D4_HO181 PF_QoL Questionnaire 2_ statement_2025-522767-15 | 1 |
| Recruitment arrangements (for publication) | K1_HO181_Recruitment arrangements_Estonia | 1.0 |
| Recruitment arrangements (for publication) | K1_HO181_Recruitment-arrangements_DNK_Public | 1 |
| Recruitment arrangements (for publication) | K1_HO181_Recruitment-Arrangements_LT_LTU_Public | 1 |
| Recruitment arrangements (for publication) | K1_HO181_Recruitment-arrangements_NL_English | N/A |
| Recruitment arrangements (for publication) | K1_HOVON 181 AML_Recruitment and IC procedure_FIN_Fin_Public | 1 |
| Recruitment arrangements (for publication) | K1_HOVON 181 AML_Recruitment Arrangements_BE_Engllish_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_HOVON_181_AML-AMLSG_37-25_Recruitment-Arrangements_ESP_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_HOVON-181_Recruitment-Arrangements_AT | 1 |
| Recruitment arrangements (for publication) | K1_HOVON-181_Recruitment-Arrangements_DE_Public | 1 |
| Recruitment arrangements (for publication) | K1_HOVON-181_Recruitment-Arrangements_IE | N/A |
| Recruitment arrangements (for publication) | K1_HOVON-181_Recruitment-arrangements_ITA_ENG_Public | 1 |
| Recruitment arrangements (for publication) | K1_HOVON-181_Recruitment-Arrangements_SWE_swe_Public | n/a |
| Recruitment arrangements (for publication) | K1_HOVON-181-AML_Recruitment-arrangements_NOR_Public | 1 |
| Recruitment arrangements (for publication) | K1_HOVON181_Recruitment-Arrangments_POL_POL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ HOVON-181_Main-ICF_SWE_swe_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ HOVON-181_Optional-storage-of-samples-ICF_SWE_swe_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ HOVON-181_Pregnancy-ICF_SWE_swe_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ HOVON-181_Screening-ICF_SWE_swe_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HO181_Biobank-ICF_LT_LTU_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_Future-research_ICF_DNK_Dan_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Biobank_EST_ENG_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Biobank_EST_EST_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Main_EST_ENG_Public | 2 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Main_EST_EST_Public | 2 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Pregnancy_EST_ENG_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Pregnancy_EST_EST_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Screening_EST_ENG_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HO181_ICF_Screening_EST_EST_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HO181_Main_ICF_DNK_Dan_Public | 2 |
| Subject information and informed consent form (for publication) | L1_HO181_Main-ICF_LTU_lit_Public | 2 |
| Subject information and informed consent form (for publication) | L1_HO181_Patient Card_EST_ENG_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_Patient Card_EST_EST_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_Patient Diary Bleximinib_Placebo_EST_ENG_Public | 02 |
| Subject information and informed consent form (for publication) | L1_HO181_Patient Diary Bleximinib_Placebo_EST_EST_Public | 02 |
| Subject information and informed consent form (for publication) | L1_HO181_Pregnancy_ICF_DNK_Dan_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_Pregnancy-ICF_LTU_lit_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_Right-Not-To-Know-Consent_DNK_Dan_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HO181_Screening_ICF_DNK_Dan_Public | 5 |
| Subject information and informed consent form (for publication) | L1_HO181_Screening-ICF_LTU_lit_Public | 5 |
| Subject information and informed consent form (for publication) | L1_HO181_SIS-and-ICF-Main_NL _Dutch_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_HO181_SIS-and-ICF-Pregnancy_NL _Dutch_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HO181_SIS-and-ICF-Screening_NL _Dutch_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Biobank ICF_FIN_Fin_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Main ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Main ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Main ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Main ICF_FIN_Fin_Public | 2 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Pregnancy ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Pregnancy ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Pregnancy ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Pregnant participant ICF_FIN-Fin_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Pregnant partner ICF_FIN-Fin_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Screening ICF_BE_Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Screening ICF_BE_English_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Screening ICF_BE_French_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Screening ICF_FIN_Fin_Public | 5 |
| Subject information and informed consent form (for publication) | L1_HOVON 181 AML_Sponsor Statement_Main ICF_BE_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON_181_AML-AMLSG_37-25_Main_ICF_ESP_SPA_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HOVON_181_AML-AMLSG_37-25_Pregnant-Partner_ICF_ESP_SPA_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON_181_AML-AMLSG_37-25_Screening_ICF_ESP_SPA_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Biobank-ICF_AUT_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Biobank-ICF_DE_German_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Main-ICF_AUT_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Main-ICF_DE_German_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_MAIN-ICF_ITA_ITA_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Pregnancy-FU-ICF_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Pregnancy-ICF_AUT_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Pregnant-Participant-ICF_ITA_ITA_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Pregnant-Partner-ICF_ITA_ITA_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON-181_Screening-ICF_ITA_ITA_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Broad-Consent-Future-Research-ICF_NOR_Norwegian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Main-ICF_IE_English_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Main-ICF_NOR_Norwegian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Optional Biobank-ICF_IE_English_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Pregnancy-ICF_IE_English_Public | 1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Pregnancy-ICF_NOR_Norwegian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Screening-ICF_IE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON-181-AML_Screening-ICF_NOR_Norwegian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HOVON181_Main_ICF_POL_POL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HOVON181_Pregnancy_ICF_POL_POL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HOVON181_Screening_ICF_POL_POL_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2_HOVON-181-AML_Patient-Card_IE_English_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_HOVON-181-AML_Patient-Diary-Bleximenib_IE_English_Public | 02 |
| Subject information and informed consent form (for publication) | M2_HOVON-181_ICF-contact-list_AT_Public | n/a |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis DE 2025-522767-15 Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis ENG 2025-522767-15 _Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis ES 2025-522767-15_Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis FR 2025-522767-15 Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis NO 2025-522767-15_Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis PL 2025-522767-15_Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis SE 2025-522767-15_Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181 Protocol synopsis_IT 2025-522767-15_Public | 1 |
| Synopsis of the protocol (for publication) | D1 HO181_Protocol synopsis NL 2025-522767-15 Public | 1 |
| Synopsis of the protocol (for publication) | D1_HO181 Protocol_synopsis LT_2025-522767-15 Public | 1 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-04 | Netherlands | Acceptable 2026-01-14
|
2026-01-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-20 | Netherlands | Acceptable 2026-01-14
|
2026-01-20 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-08 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-22 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-13 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-24 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2026-01-30 | 2026-04-02 | ||
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-20 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-24 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-22 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2026-01-30 | Acceptable 2026-01-14
|
2026-03-24 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2026-01-30 | Acceptable 2026-01-14
|
2026-04-23 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-30 | Acceptable | 2026-04-08 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-05 | Netherlands | Acceptable | 2026-02-18 |
| 15 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-12 | Acceptable | 2026-02-27 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-20 | Acceptable | 2026-03-24 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-05-06 | Acceptable | 2026-05-11 |