Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
584
Countries
12
Sites
106
Acute Myeloid Luekemia
To compare the efficacy of bleximenib and VEN+AZA vs VEN+AZA alone
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To compare the efficacy of bleximenib and VEN+AZA vs VEN+AZA alone
Conditions and MedDRA coding
Acute Myeloid Luekemia
| 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
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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.
- 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.
- 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
- 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)
- 5. WBC count < 25 X 10^9/ L
Exclusion criteria 5
- 1. Known active leukemic involvement of the CNS
- 2. History of myelofibrosis
- 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.
- 4. Chronic respiratory disease requiring supplemental oxygen
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- Dual primary endpoints: CR and OS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD11825465 · 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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11370367 · 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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 3
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
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
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
Auxiliary 4
Azacitidine betapharm 25 mg/mL powder for suspension for injection
PRD7974972 · Product
- Active substance
- Azacitidine
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC07 — -
- Marketing authorisation
- EU/1/19/1416/001
- MA holder
- BETAPHARM ARZNEIMITTEL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaged and relabeled
Venclyxto 100 mg film-coated tablets
PRD6353842 · Product
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/007
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaged and relabeled
Venclyxto 50 mg film-coated tablets
PRD6353830 · Product
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/004
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaged and relabeled
Venclyxto 100 mg film-coated tablets
PRD6353834 · Product
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/005
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaged and relabeled
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Pharma Bio-Research Group ORG-100006268
|
Assen, Netherlands | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other, Interactive response technologies (IRT), Data management, E-data capture |
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Laboratory analysis |
| Ppd Inc. ORG-100018960
|
Middleton, United States | Laboratory analysis |
| Hematogenix ORG-100047219
|
Cyberjaya, Malaysia | Laboratory analysis |
| Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119
|
Shanghai, China | Laboratory analysis |
Locations
12 EU/EEA countries · 106 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 14 | 6 |
| Belgium | Ongoing, recruiting | 16 | 8 |
| Czechia | Ongoing, recruiting | 17 | 7 |
| Denmark | Ongoing, recruiting | 10 | 4 |
| France | Ongoing, recruiting | 27 | 13 |
| Germany | Ongoing, recruiting | 26 | 13 |
| Greece | Ongoing, recruiting | 17 | 7 |
| Hungary | Authorised, recruitment pending | 14 | 7 |
| Italy | Ongoing, recruiting | 35 | 14 |
| Poland | Ongoing, recruiting | 16 | 6 |
| Portugal | Ongoing, recruiting | 20 | 5 |
| Spain | Ongoing, recruiting | 34 | 16 |
| Rest of world
Israel, Brazil, Japan, United Kingdom, Taiwan, China, Canada, Mexico, Korea, Republic of, United States, Australia, Turkey
|
— | 338 | — |
Investigational sites
Klinikum Wels-Grieskirchen GmbH
Innere Med IV Schwerpunkte Haematologie Intern Onkologie, Palliativmedizin, Nephrologie, Dialyse, Grieskirchner Strasse 42, 4600, Wels
Johannes Kepler University Linz
Innere Medizin 3 Haematologie und Internistische Onkologie, Med Campus III, Krankenhausstrasse 9, Linz
Ordensklinikum Linz GmbH
Medizinische Onkologie und Haematologie, Fadingerstrasse 1, 4020, Linz
SCRI CCCIT Ges.m.b.H.
Universitaetsklinik fuer Innere Medizin III, Haematologie Onkologie Rheumtologie Infektiologie, Muellner Hauptstrasse 48, 5020, Salzburg
Klinik Hietzing
5 Medizinische Abteilung Innere Medizin mit Haematologie Onkologie und Palliativstation, Wolkersbergenstrasse 1, Hietzing, Vienna
Medical University Of Vienna
Klinische Abteilung fur Hamatologie und Hamostaseologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Algemeen Ziekenhuis Delta
Hematology, Deltalaan 1, 8800, Roeselare
Universiteit Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Ziekenhuis Oost Limburg
Hematology, Synaps Park 1, 3600, Genk
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
CHU Helora
Hematology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Clinique Saint-Pierre
Hematology, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Antwerpen
Hematologie, Drie Eikenstraat 655, 2650, Edegem
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Kralovske Vinohrady
Interni hematologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Plzen
Hematologicko-onkologicke oddeleni, Alej Svobody 923/80, 323 00, Plzen 23
Institute Of Hematology And Blood Transfusion
Ambulance, U Nemocnice 2094/1, Nove Mesto, Prague
Fakultni Nemocnice Hradec Kralove
Interni hematologicka klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika - klinika hematologie 1.LF a VFN, U Nemocnice 499/2, Nove Mesto, Prague
Region Sjaelland
Dept. of Hematology, Sygehusvej 10, 4000, Roskilde
Odense University Hospital
Dept of hematology, J B Winsloews Vej 4, 5000, Odense C
Aalborg University Hospital
Dept. of Hematology, Moelleparkvej 4, 9000, Aalborg
Rigshospitalet
Dept. of Hematology, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
University Hospital Of Clermont-Ferrand
Hematology and cellular therapy department and oncology department, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
CHRU De Nancy
Hematology, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Centre Hospitalier Universitaire D'Angers
Hematology, 4 Rue Larrey, 49100, Angers
Institut Paoli Calmettes
Hematology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Nice
Hematology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Rennes
Hematology, 2 Rue Henri Le Guilloux, 35000, Rennes
Assistance Publique Hopitaux De Paris
Senior Hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Toulouse
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire Reims
Hematology, Rue Du General Koenig, 51092, Reims Cedex
Groupement Des Hopitaux De L'Institut Catholique De Lille
Onco-Hematology, Boulevard De Belfort, P. O. Box 387, Lille Cedex
Centre Hospitalier Universitaire De Montpellier
Hematology, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
University Hospital Cologne AöR
Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Technische Universitaet Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Medical Center - University Of Freiburg
Klinik fuer Innere Medizin I, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
University Medical Center Hamburg-Eppendorf
Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Innere Medizin II, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsmedizin Goettingen
Klinik für Hämatologie & medizinische Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Augsburg
Medizinische Klinik III, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
General University Hospital Of Patras
Hematology Clinic, Department of Internal Medicine, Rio, 265 04, Patras
University General Hospital Of Ioannina
Haematology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Thessaloniki Ahepa
Hematology Department, 1st St Kiriakidis Str, 546 36, Thessaloniki
Evaggelismos Hospital
Hematology and Lymphoma Clinic, Bone Marrow Transplant Unit, Ipsiladou 45-47, 106 76, Athens
University General Hospital Of Alexandroupoli
Hematology Clinic, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department, Exochi, 570 10, Thessaloniki
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Department of Internal Medicine - Propaedeutic, Rimini 1, 124 61, Chaidari
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Szent Istvan Utca 68, 4400, Nyiregyhaza
University Of Szeged
II. Belgyógyászati Klinika és Kardiológiai Központ, Semmelweis Utca 8, 6725, Szeged
University Of Debrecen
Debreceni Egyetem Klinikai Kozpont, Hematologia, Nagyerdei Korut 98, 4032, Debrecen
Semmelweis University
II. Belgyogyaszat Hematologia, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
University Of Pecs
Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika, Ifjusag Utja 13, 7624, Pecs
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz, II Belgyogyaszat Haematologia, Vasvari Pal Utca 2-4, 9024, Gyor
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely, Albert Florian Ut 5-7, 1097, Budapest IX
Fondazione IRCCS Policlinico San Matteo
UOC Ematologia I, Viale Camillo Golgi 19, 27100, Pavia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Hospital Santa Maria Della Misericordia
Ematologia, Piazzale Giorgio Menghini 1, 06129, Perugia
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
UOC Ematologia, Via Giuseppe Melacrino 21, 89124, Reggio Calabria
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Ematologia, Dipartimento Scienze Mediche e Chirurgiche, Via Pietro Albertoni 15, 40138, Bologna
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Onco-ematologia, UOC Ematologia e Centro Trapianti, Via Lombroso S/N, 61122, Pesaro
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dipartimento Area Medica, S.C. Ematologia, Via Francesco Sforza 28, 20122, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O.C Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Unita Sanitaria Locale Della Romagna
Oncoematologia, U.O. Ematologia, Viale Vincenzo Randi 5, 48121, Ravenna
Humanitas Mirasole S.p.A.
Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Ematologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Dipartmento di Ematologia e Oncologia, Corso Bramante 88, 10126, Turin
ASST Grande Ospedale Metropolitano Niguarda
Dip Ematologia, Oncologia e Medicina Molecolare - SC Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Casa Sollievo Della Sofferenza
UOC di Ematologia e Trapianto di Cellule Staminali Emopoietiche, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii, Transplantologii i Terapii Komórkowych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddzial Hematologii i Transplantologii i Chorob Wewnetrznych – Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Hematologii,Chorob Wewnetrznych i Angiologii, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Hematologii, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Hematologia, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Hematologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Sao Jose E.P.E.
Hematologia, Rua Jose Antonio Serrano, 1150-199, Lisbon
Unidade Local de Saude de Sao Joao E.P.E.
Hematologia, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude De Santo Antonio E.P.E.
Hematologia, Largo Professor Abel Salazar, 4050-011, Porto
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
Hematology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital De Jerez De La Frontera
Hematology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Complexo Hospitalario Universitario A Coruna
Hematology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital De La Santa Creu I Sant Pau
Hematology, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 |
|---|---|---|---|---|---|
| Austria | 2025-10-24 | 2026-03-30 | |||
| Belgium | 2025-08-20 | 2025-08-20 | |||
| Czechia | 2025-09-05 | 2025-09-05 | |||
| Denmark | 2025-07-29 | 2026-01-06 | |||
| France | 2025-09-08 | 2025-09-08 | |||
| Germany | 2025-10-07 | 2025-10-07 | |||
| Greece | 2025-09-02 | 2025-09-02 | |||
| Italy | 2025-09-04 | 2025-09-04 | |||
| Poland | 2025-08-08 | 2025-08-08 | |||
| Portugal | 2025-10-15 | 2025-10-15 | |||
| Spain | 2025-08-07 | 2025-08-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 96 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol_2024-520154-38 | Am5-EEA2 |
| Protocol (for publication) | REDACTED_D4_PF_EQ-5D-5L_multicountry_multilingual_2024-520154-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_FACT-Leu_multicountry_multilingual_2024-520154-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Pro-AE_multicountry_multilingual_2024-520154-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_QLQ-C30_multicountry_multilingual_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _DE_ENG_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _ES_ENG_2024-520154-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _GR_eng_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | Redacted_K1_Recruitment Arrangements _HU_ENG_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_AT_ENG_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BE_Eng_2024-520154-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_CZ_cze_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DK_Eng_2024-520154-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_FR_FRE_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_IT_ENG_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PL_pol_2024-520154-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PT_ENG_2024-520154-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_ L1_SIS and ICF Pregnant Participant_GR_GRE_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Biobanking_IT_ITA_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Highlighted_CZ_cze_2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF_HU_HUN_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_CZ_cze_2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_DK_dan_2024-520154-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2024-520154-38 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_FR_FRE_2024-520154-38 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_IT_ITA_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_pol_2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PT_POR_2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genetic_HU_HUN_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main NSM_GR_GRE_2024-520154-38 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Fre_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_GR_GRE_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Clinical_AT_GER_2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Future Research_DK_dan_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_CZ_cze_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_FR_FRE_2024-520154-38 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Participant NSM_GR_GRE_2024-520154-38 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner _GR_GRE_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner NSM_GR_GRE_2024-520154-38 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_AT_GER_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Dut_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Fre_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_cze_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DE_GER_2024-520154-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_dan_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2024-520154-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_HU_HUN_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_IT_ITA_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_pol_2024-520154-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PT_POR_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Caregiver Greenphire_IT_ITA_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Clinical_IT_ITA_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Family_IT_ITA_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_CZ_cze_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Pregnant Partner_IT_ITA_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Right to Reject Knowledge_DK_dan_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _GR_GRE_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal ICF_HU_HUN_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal NSM_GR_GRE_2024-520154-38 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_AT_GER_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_cze_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_DE_GER_2024-520154-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_FR_FRE_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_IT_ITA_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PL_pol_2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical Informed Consent Form_DE_GER_ 2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF Contact Data Sheet_AT_ENG_2024-520154-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Patient Travel Reimbursement_IT_ITA_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Privacy Child Exposed to IP_IT_ITA_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_AT_GER_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_cze_2024-520154-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DK_dan_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FRE_2024-520154-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_GR_GRE_2024-520154-38 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_LOCAL_PT_POR_2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL _2024-520154-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PT_POR_2024-520154-38 | 3 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_AT_GER_2024-520154-38 | Am5_EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Dut_2024-520154-38 | Am5-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Fre_2024-520154-38 | Am5-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Ger_2024-520154-38 | Am5-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_cze_2024-520154-38 | Am5-EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2024-520154-38 | Am5 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2024-520154-38 | Am5-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_GR_GRE_2024-520154-38 | Am5-EEA2 |
| Synopsis of the protocol (for publication) | Redacted_D1_Protocol Synopsis_HU_HUN_2024-520154-38 | Am3-EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_IT_ITA_2024-520154-38 | Am5-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_POL_2024-520154-38 | Am5 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PT_POR_2024-520154-38 | Am5 EEA-2 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-14 | France | No conclusion 2025-07-07
|
2025-07-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-23 | France | No conclusion 2025-07-07
|
2025-07-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-11 | France | No conclusion | 2025-10-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-11 | No conclusion | 2025-10-17 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-22 | France | Acceptable 2026-02-09
|
2026-02-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-24 | Acceptable | 2026-03-31 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-02 | Acceptable | 2026-03-10 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2026-03-06 | Acceptable 2026-02-09
|
2026-05-21 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-06 | Acceptable | 2026-03-30 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-16 | Acceptable | 2026-04-20 |