Clinical trial • Phase III • Oncology

REVUMENIB for Acute myeloid leukemia (NPM1-mutated)

Phase III trial of REVUMENIB for Acute myeloid leukemia (NPM1-mutated).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Acute myeloid leukemia (NPM1-mutated)
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
14-10-2025
First CTIS Authorization Date
13-02-2026

Trial design

Randomised, placebo for revumenib tablets plus intensive chemotherapy (placebo + ic). intensive chemotherapy agents listed in trial materials include cytarabine and an anthracycline (idarubicin or daunorubicin) as per protocol; specific doses/schedules are per protocol and not fully specified in the ctis summary.-controlled Phase III trial in Austria, France, Italy and others.

Randomised
Yes
Comparator
Placebo for Revumenib tablets plus intensive chemotherapy (placebo + IC). Intensive chemotherapy agents listed in trial materials include cytarabine and an anthracycline (idarubicin or daunorubicin) as per protocol; specific doses/schedules are per protocol and not fully specified in the CTIS summary.
Target Sample Size
139

Eligibility

Recruits 139 paediatric patients.

Pregnancy Exclusion
Pregnant or nursing females.
Vulnerable Population
Participants include minors (from age ≥12). The protocol requires that the participant or the participant’s health care proxy be able and willing to provide written informed consent or assent and be able to follow study instructions. Country-specific consent/assent and parental consent forms are provided (examples in the document list: Country ICF Assent Child 12-13, Country ICF Assent Child 14-17, Country ICF Main Adult Parent), and subject information/ICF documents are available in multiple country languages.

Inclusion criteria

  • {"criterion_text":"- Participants must be ≥12 years of age and weigh ≥40 kg at the time of signing the informed consent form (ICF)."}
  • {"criterion_text":"- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test within 72 hours before the initiation of protocol therapy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be obtained. Participants are considered to be not of childbearing potential if they are considered to be post-menopausal or surgically sterilized. Females who have been amenorrheic for at least 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible reason."}
  • {"criterion_text":"- a. Females of childbearing potential must be willing to use a highly effective method of contraception from the time of first study intervention dose through the required contraceptive period and must be willing to refrain from in vitro fertilization and egg donation during the required contraceptive period. b. Males must be surgically sterile (eg. bilateral orchiectomy or vasectomy) or agree to use barrier contraception (male condoms) from the time of first study intervention dose through the required contraceptive period. Males must be willing to refrain from sperm donation during the required contraceptive period."}
  • {"criterion_text":"- Participant or participant’s health care proxy is able and willing to provide written informed consent or assent and able to follow study instructions."}
  • {"criterion_text":"- Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy. The International Consensus Classification AML classification system will be used for this study"}
  • {"criterion_text":"- Presence of an NPM1 mutation consistent with an NPM1c variant. Local mutation testing will be used to determine participant eligibility. Mutation status will subsequently be confirmed centrally."}
  • {"criterion_text":"- White blood cell (WBC) ≤25 × 109 /L by the time of the start of revumenib/placebo at Cycle 1 Day 8 (C1D8). Cytoreduction with hydroxyurea, leukapheresis or a single dose of cytarabine is allowed up to and including Induction C1D1."}
  • {"criterion_text":"- Have a life expectancy of ≥3 months as judged by the Investigator."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2 if 18 to 65 years or 0 to 1 if aged ≥65 years; Karnofsky Performance Scale of ≥40 (if aged ≥16 years and <18 years); Lansky Performance Score of ≥40 (if aged <16 years)"}
  • {"criterion_text":"- Creatinine Clearance (CLCr) ≥30 mL/min. CLCr calculation should be based on local institutional practice for age-appropriate determination (Cockcroft Gault formula for adults). A 24-hour urine collection may also be used to CLCr."}
  • {"criterion_text":"- Adequate liver function defined as: • Total bilirubin <1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin (unless attributed to leukemic involvement or Gilbert’s syndrome). • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3 × ULN (unless attributed to leukemic involvement)."}
  • {"criterion_text":"- Adequate cardiac function defined as ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan."}

Exclusion criteria

  • {"criterion_text":"- Not a candidate for anthracycline-based therapy for Induction."}
  • {"criterion_text":"- Pregnant or nursing females."}
  • {"criterion_text":"- Participants may not have received AML-directed therapy before randomization, with the following exceptions: hydroxyurea, leukapheresis for the acute management of hyperleukocytosis and Days 1 to 7 of protocol-defined Induction chemotherapy"}
  • {"criterion_text":"- Not a candidate for continuous infusion cytarabine during Induction or intermediate dose cytarabine for Consolidation."}
  • {"criterion_text":"- The following exclusions apply related to concomitant use of CYP3A4 inhibitors: • Participants who will not receive revumenib with coadministration of a strong CYP3A4i (eg, itraconazole, ketoconazole, posaconazole, or voriconazole) must discontinue all strong CYP3A4 inhibitors at least 7 days before the first dose of revumenib or placebo. They will receive the revumenib or placebo and they may continue to receive moderate or weak CYP3A4 inhibitors, including fluconazole and isavuconazole. • Participants who will receive revumenib or placebo with coadministration of a strong CYP3A4i (eg, itraconazole, ketoconazole, posaconazole, or voriconazole) must have started the treatment at least 24 hours before the first dose of revumenib or placebo."}
  • {"criterion_text":"- Participants requiring the concurrent use of medications known or suspected to prolong the QT/QTc interval, with the exception of drugs with low risk of QT/QTc prolongation that are used as standard supportive therapies (eg, diphenhydramine, famotidine, ondansetron, sulfamethoxazole and trimethoprim) and the azoles permitted."}
  • {"criterion_text":"- Current or future participation in another investigational drug study, scheduled to occur during this study, or has received an investigational agent within 14 days or 5 half-lives of the study intervention, whichever is longer) before dosing on C1D1 (Cycle 1 Day 1)."}
  • {"criterion_text":"- Presence of FLT3 (FMS-like tyrosine kinase 3) mutation (either internal tandem duplication or tyrosine kinase domain) with a VAF ≥5%."}
  • {"criterion_text":"- Clinical signs/symptoms of hyperleukocytosis/leukostasis that have failed therapy including hydroxyurea or leukapheresis (of at least 3 days duration)."}
  • {"criterion_text":"- History of prior allogeneic stem cell transplant for another malignancy or solid organ transplant."}
  • {"criterion_text":"- Diagnosis of active acute promyelocytic leukemia."}
  • {"criterion_text":"- Cardiac Disease: • Any of the following within the 6 months before study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack. Participants with controlled atrial fibrillation are allowed to enroll. • QTcF (Fridericia’s corrected QT interval) >450 msec at Screening. • Diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome."}
  • {"criterion_text":"- Isolated extramedullary disease."}
  • {"criterion_text":"- Presence of life-threatening bleeding or thrombosis."}
  • {"criterion_text":"- Active central nervous system (CNS) disease (cytologic, eg, any blasts on cytospin or radiographic). Participants who have cleared CNS disease by at least one negative tap before dosing may be randomized, and prophylactic intrathecal chemotherapy may be continued while on study."}
  • {"criterion_text":"- [EU only] Otherwise considered to be inappropriate for the study by the investigator including where other treatment options, such as gemtuzumab ozogamicin, are preferred according to local institutional practice and prescribing guidelines."}
  • {"criterion_text":"- Gastrointestinal Disease (GI): • Any GI issue of the upper GI tract likely to affect oral drug absorption or ingestion (eg, gastric bypass, gastroparesis). • Cirrhosis with a Child-Pugh score of B or C, or National Cancer Institute (NCI) Organ Dysfunction Working Group category of Severe Dysfunction. • Inability to swallow oral medications"}
  • {"criterion_text":"- Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy). For participants with therapy-related leukemia, primary disease must be in remission."}
  • {"criterion_text":"- Participants known to have 1 of the following genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known genetic bone marrow failure syndrome."}
  • {"criterion_text":"- History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that in the Investigator’s opinion might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate."}
  • {"criterion_text":"- If the participant is known to be human immunodeficiency virus (HIV)-positive, the participant must have an undetectable HIV viral load within the previous 6 months. If viral load testing has not been performed within the previous 6 months, it must be performed during Screening."}
  • {"criterion_text":"- Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection. Participants with a history of HCV infection who have completed curative therapy for HCVat least 12 weeks before the Screening Visit and have a documented undetectable viral load at the Screening Visit are eligible for randomization."}
  • {"criterion_text":"- Uncontrolled active infection of any type. Infections under control with antibiotic treatment are acceptable for study entry."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- EFS: Defined as the time from the date of randomization to the date of Induction treatment failure, relapse or death due to any cause, whichever occurs first.\n- MRDBM (-) CR rate: Defined as the percentage of participants with CR","definition_or_measurement_approach":"EFS: Defined as the time from the date of randomization to the date of Induction treatment failure, relapse or death due to any cause, whichever occurs first. MRDBM (-) CR rate: Defined as the percentage of participants with CR."}

Secondary endpoints

  • {"endpoint_text":"- OS: Defined as the time from the date of randomization to the date of death from any cause.","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
  • {"endpoint_text":"- EFS (Investigator-assessed): Defined as the time from the date of randomization to the date of Induction treatment failure, relapse or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"Investigator-assessed event-free survival by same definition as primary EFS."}
  • {"endpoint_text":"- MRDBM (-) CR rate: Defined as the percentage of participants with CR (Investigator-assessed) who achieve MRDBM (-) status by molecular assay","definition_or_measurement_approach":"Percentage of investigator-assessed CR participants who are MRDBM (-) by molecular assay."}
  • {"endpoint_text":"- MRDPB (-) CR rate: Defined as the percent of participants with CR (Investigator assessed) who achieve MRDPB (-) status by molecular assay","definition_or_measurement_approach":"Percentage of investigator-assessed CR participants who are MRDPB (-) by molecular assay."}
  • {"endpoint_text":"- MRDBM (-) CR rate: Defined as the percent of participants with CR who achieve MRDBM (-) status.","definition_or_measurement_approach":"Percentage of CR participants achieving MRDBM (-)."}
  • {"endpoint_text":"- CR rate (Investigator-assessed): Defined as the percentage of participants who achieve CR","definition_or_measurement_approach":"Investigator-assessed complete remission rate."}
  • {"endpoint_text":"- CRc rate (Investigator-assessed): Defined as the rate of CR + CRh (complete remission with partial hematologic recovery) + Cri (complete remission with incomplete hematologic recovery).","definition_or_measurement_approach":"Composite remission rate combining CR, CRh and CRi as assessed by investigator."}
  • {"endpoint_text":"- ORR (Investigator-assessed): Defined as the rate of CR + CRh + CRi + MLFS (morphologic leukemia-free state) + PR (partial response).","definition_or_measurement_approach":"Overall response rate combining CR, CRh, CRi, MLFS and PR by investigator assessment."}
  • {"endpoint_text":"- Duration of CR: Defined as time from first date of first CR to relapse or death.","definition_or_measurement_approach":"Measured from date of first documented CR to relapse or death."}
  • {"endpoint_text":"- Duration of CRc: Defined as time from first date of first CRc to relapse or death.","definition_or_measurement_approach":"Measured from date of first documented CRc to relapse or death."}
  • {"endpoint_text":"- DOR: Defined as time from date of first documented response (CR, CRh, CRi, PR, or MLFS) to the first documented relapse or death.","definition_or_measurement_approach":"Duration of response measured from first documented response to relapse or death."}
  • {"endpoint_text":"- •\tFrequency, duration, and severity of TEAEs (treatment-emergent adverse events), TRAEs (treatment-related adverse event), and SAEs. •\tIncidence and shifts from baseline of clinically significant clinical laboratory abnormalities. •\tChange from baseline in other observations related to safety, including ECGs, vital signs, and performance status.","definition_or_measurement_approach":"Safety endpoints: incidence, severity and duration of TEAEs/TRAEs/SAEs; clinically significant lab abnormalities; changes from baseline in ECGs, vitals and performance status."}

Recruitment

Planned Sample Size
139
Recruitment Window Months
49
Consent Approach
Informed consent must be provided in writing by the participant or the participant’s health care proxy; assent procedures are used for minors. Country-specific informed consent and assent documents are provided (examples: Country ICF Assent Child 12-13, Assent Child 14-17, Country ICF Main Adult Parent). Multiple language versions of ICFs/assent forms are available for participating countries (documents in German, French, English, Italian, Spanish, Polish, Greek, Lithuanian, Portuguese, Hungarian, Czech, Dutch among others).

Geography

Total Number Of Sites
74
Total Number Of Participants
139

Austria

Earliest CTIS Part Ii Submission Date
15-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
32
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name
104003: Abteilung für Innere Medizin und Hämato-Onkologie
Contact Person Name
Thamer Sliwa
Contact Person Email
thamer.sliwa@kages.at
Site Name
Ordensklinikum Linz GmbH
Department Name
104005: Haematologie mit Stammzelltransplantation, Hämostaseologie & medizinische Onkologie
Contact Person Name
Sigrid Machherndl-Spandl
Site Name
Medical University Of Graz
Department Name
104001: Universitätsklinik für Innere Medizin, Klinische Abteilung für Hämatologie
Contact Person Name
Armin Zebisch
Contact Person Email
armin.zebisch@medunigraz.at
Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
104004: Abteilung für Innere Medizin und Hämatologie und internistische Onkologie
Contact Person Name
Sandra Eder
Contact Person Email
sandra.eder@kabeg.at

France

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
66
Number Of Sites
10
Number Of Participants
55

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
125010: Service des Maladies du Sang
Contact Person Name
Celine Berthon
Contact Person Email
celine.berthon@chru-lille.fr
Site Name
Hospices Civils De Lyon
Department Name
125003: Hematologie clinique
Contact Person Name
Mael Heiblig
Contact Person Email
mael.heiblig@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
125005: Hématologie Clinique - IHBN
Contact Person Name
Sylvain Chantepie
Contact Person Email
chantepie-s@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
125002: Service d'hématologie Clinique
Contact Person Name
Thomas Cluzeau
Contact Person Email
cluzeau.t@chu-nice.fr
Site Name
Centre Hospitalier De Versailles
Department Name
125012: Service d'Hematologie et d'Onc
Contact Person Name
Philippe Rousselot
Contact Person Email
phrousselot@ght78sud.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
125001: Hematology clinic and cellular therapy
Contact Person Name
Arnaud Pigneux
Contact Person Email
arnaud.pigneux@chu-bordeaux.fr
Site Name
Centre Henri Becquerel
Department Name
125011: Unité de Recherche Clinique
Contact Person Name
Emilie LEMASLE-HUE
Site Name
Clinique Victor Hugo
Department Name
125008
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
125009: Hématologie Clinique et Thérapie cellulaire
Contact Person Name
Pascal Turlure
Contact Person Email
pascal.turlure@chu-limoges.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
125004: Service Hématologie
Contact Person Name
Anne Banos
Contact Person Email
abanos@ch-cotebasque.fr

Italy

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
6
Number Of Sites
18
Number Of Participants
65

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
138016: Ematologia e Trapianto di Midollo
Contact Person Name
Luca Vago
Contact Person Email
vago.luca@hsr.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
138010: Clinica Ematologica
Contact Person Name
Mario Tiribelli
Contact Person Email
mario.tiribelli@uniud.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
138009: Ematologia
Contact Person Name
Sara Butera
Contact Person Email
sara.butera@ospedale.al.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
138007: Ematologia
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@med.unipi.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
138001: Oncoematologia
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
138015: Servizio e DH di Ematologia
Contact Person Name
Patrizia Chiusolo
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
138017: Oncologia Medica ed Ematologia
Contact Person Name
Elena Crisà
Contact Person Email
elena.crisa@ircc.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
138013: Ematologia e Trapianti CSE
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
138012: Ematologia
Contact Person Name
Federica Monaco
Contact Person Email
federica.monaco@auslromagna.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
138005: Ematologia
Contact Person Name
Mario Luppi
Contact Person Email
mluppi@unimore.it
Site Name
La Maddalena S.p.A.
Department Name
138011: Emato-Oncologia e TMO
Contact Person Name
Maurizio Musso
Contact Person Email
musso@lamaddalenanet.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
138018: Ematologia, Dipartimento di Ematologia, Oncologia e Medicina Molecolare
Contact Person Name
Roberto Cairoli
Site Name
Azienda Ospedaliera Di Perugia
Department Name
138006: Ematologia
Contact Person Name
Maria Paola Martelli
Contact Person Email
maria.martelli@unipg.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
138008: Ematologia
Contact Person Name
Federico Lussana
Contact Person Email
flussana@asst-pg23.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
138003
Contact Person Name
Monica Fumagalli
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
138002: Ematologia - Dipartimento Oncologico.
Contact Person Name
Alessandro Vannucchi
Contact Person Email
amvannucchi@unifi.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
138017: Oncologia Medica ed Ematologia
Contact Person Name
Elena Crisà
Contact Person Email
elena.crisa@ircc.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
138004: Unità Operativa Complessa di Ematologia - Pad. 8
Contact Person Name
Cristina Papayannidis
Contact Person Email
cristina.papayannidis@unibo.it

Lithuania

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
21
Number Of Sites
2
Number Of Participants
21

Sites

Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
144001: Hematologie
Contact Person Name
Andrius Zucenka
Contact Person Email
andrius.zucenka@santa.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
144002: Hematology
Contact Person Name
Rolandas Gerbutavicius
Contact Person Email
gerbrola@yahoo.com

Romania

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
10
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
164203: Hematology
Contact Person Name
Mihnea Zdrenghea
Contact Person Email
mzdrenghea@umfcluj.ro
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
164202: Internal Medicine I
Contact Person Name
Ioan Macarie
Contact Person Email
imacarie@rdslink.ro
Site Name
Institutul Regional De Oncologie Iasi
Department Name
164204: Hematology
Contact Person Name
Catalin Danaila
Contact Person Email
c_danaila@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
164201: Hematology II
Contact Person Name
Georgeta Georgescu
Contact Person Email
dana1601@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
12
Number Of Sites
12
Number Of Participants
45

Sites

Site Name
Hospital San Pedro De Alcantara
Department Name
172401: Hematologia
Contact Person Name
Juan Miguel Bergua Burgues
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
172403: Hematologia
Contact Person Name
Eduardo Rodriguez Arboli
Contact Person Email
edurodarb@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
172411: Hematologia
Contact Person Name
Montserrat Arnan Sangerman
Contact Person Email
marnan@iconcologia.net
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
172407: Hematología
Contact Person Name
Guadalupe Oñate
Contact Person Email
gonate@santpau.cat
Site Name
MD Anderson Cancer Center
Department Name
172408: Hematología
Contact Person Name
Adolfo de la Fuente Burguera
Contact Person Email
afuente@mdanderson.es
Site Name
Hospital Clinic De Barcelona
Department Name
172412: Hematología
Contact Person Name
Jordi Esteve Reyner
Contact Person Email
jesteve@clinic.cat
Site Name
Hospital Universitario De Salamanca
Department Name
172410: Hematología
Contact Person Name
Maria Belen Vidriales Vicente
Contact Person Email
mbvidri@usal.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
172402: Hematologia
Contact Person Name
Pau Montesinos Fernández
Contact Person Email
montesinos_pau@gva.es
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
172406: Hematología
Contact Person Name
Susana Vives
Contact Person Email
svives@iconcologia.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
172404: Hematologia
Contact Person Name
Ignacio Gomez Centurion
Site Name
Hospital Universitari Joan XXIII De Tarragona
Department Name
172409: Hematología
Contact Person Name
Marta Cervera
Contact Person Email
mcervera@iconcologia.net
Site Name
University Hospital Son Espases
Department Name
172405: Hematologia
Contact Person Name
Lucía García Mañó
Contact Person Email
lucia.garcia@ssib.es

Poland

Earliest CTIS Part Ii Submission Date
12-02-2026
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
10
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
161601: Oddział Hematologii i Transplantacji Szpiku
Contact Person Name
Pawel Kicinski
Contact Person Email
pkicinski@cozl.pl

Belgium

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
78
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
105602: Hematologie
Contact Person Name
Thomas De Corte
Contact Person Email
thomas.decorte@uzgent.be

Czechia

Earliest CTIS Part Ii Submission Date
16-01-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
94
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
120303: Int. hemat. a onkol. klinika
Contact Person Name
Jiri Mayer
Contact Person Email
mayer.jiri@fnbrno.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
120302: Klinika hematoonkologie
Contact Person Name
Zdenek Koristek
Contact Person Email
zdenek.koristek@fno.cz

Germany

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
76
Number Of Sites
11
Number Of Participants
45

Sites

Site Name
Muehlenkreiskliniken AöR
Department Name
127607: Universitätsklinik für Hämatologie/ Onkologie/ Hämostaseologie und Palliativmedizin
Contact Person Name
Kai Wille
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
127605
Contact Person Name
Tim Sauer
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
127608: Medizinische Klinik II
Contact Person Name
Franziska Westendorf
Contact Person Email
f.westendorf@uke.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
127602
Contact Person Name
Amin Turki
Contact Person Email
amin.turki@elisabethgruppe.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
127606: Onkologie, Hämatologie, Klinische Immunologie, Rheumatologie
Contact Person Name
Claudia Lengerke
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
127603: Hematology/Oncology
Contact Person Name
Jürgen Krauter
Contact Person Email
j.krauter@skbs.de
Site Name
Marien Hospital Duesseldorf GmbH
Department Name
127601
Contact Person Name
Aristoteles Giagounidis
Site Name
Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
Department Name
127604: Klinik für Innere Medizin II
Contact Person Name
Ulf Schnetzke
Contact Person Email
Ulf.Schnetzke@med.uni-jena.de
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
127611: Robert-Bosch-Krankenhaus GmbH - Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Martin Kaufmann
Contact Person Email
martin.kaufmann@rbk.de
Site Name
Universitaet Leipzig
Department Name
127609: Haematologie, Zelltherapie
Contact Person Name
Madlen Jentzsch
Site Name
Klinikum Chemnitz gGmbH
Department Name
127610: Internal Medicine III
Contact Person Name
Mathias Haenel
Contact Person Email
m.haenel@skc.de

Greece

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
157
Number Of Sites
3
Number Of Participants
27

Sites

Site Name
General University Hospital Of Larissa
Department Name
130002: Hematology Clinic
Contact Person Name
Georgios Vassilopoulos
Contact Person Email
gvasilop@uth.gr
Site Name
General University Hospital Of Patras
Department Name
130003: Hematology Department, Bone Marrow Transplantation Unit
Contact Person Name
Alexandros Spyridonidis
Contact Person Email
aspyridonidis183@gmail.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
130001:2nd Department of Internal Medicine Propaedeutic,Hematology,Bone Marrow Transplantation Unit
Contact Person Name
Panagiotis Tsirigotis
Contact Person Email
panagtsirigotis@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
12-02-2026
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
83
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
134803: II. Belgyógyászat Haematológia Osztály
Contact Person Name
Lázár Zsolt
Contact Person Email
lazarzsolt1982@gmail.com
Site Name
University Of Debrecen
Department Name
134802: Belgyógyászati klinika, Hematológia
Contact Person Name
Illés Árpád
Contact Person Email
illes.arpad@med.unideb.hu
Site Name
Semmelweis University
Department Name
134804: Belgyógyászati és Hematológiai Klinika
Contact Person Name
Nagy Zsolt
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
134806: Hematológiai Osztály
Contact Person Name
Renáta Csalódi
Contact Person Email
csalodi.renata@tmkorhaz.hu

Portugal

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
51
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
162002: Hematologia e Transplantação de Medula
Contact Person Name
Joana Brioso Infante
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
162001: Hematologia
Contact Person Name
Marta Pereira

Sponsor

Primary sponsor

Full Name
Syndax Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
Sponsor duties codes: 1,10,12,2,5
Name
Optimapharm Greece Consulting Research Single Member S.A.
Responsibilities
CRO responsibilities, translations

Third parties

  • {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"Interim storage for non-safety samples and PBMC/BMMC/DNA processing, long-term storage for APAC Region","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Invivoscribe Inc.","duties_or_roles":"Central Lab Processing Vendor NPM1 Biomarker during treatment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Central Lab Processing Vendor NPM1 Biomarker for Screening Only","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Data Surveillance","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC, ePRO vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"DMC/IDMC Vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Interim storage for non-safety samples and PBMC/BMMC/DNA processing, Long-term storage for EU, EMEA, EU CTR regions","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Interim storage for non-safety samples and PBMC/BMMC/DNA processing, long-term storage for US/CAN/LATAM regions","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Optimapharm Greece Consulting Research Single Member S.A.","duties_or_roles":"CRO responsibilities, translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"Medical review","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"IRT vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ledger Run Inc.","duties_or_roles":"CTA/Budgets/Inv Grants Vendor & Site Payer","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Central Lab Processing Vendor, PK Sample","organisation_type":"Pharmaceutical company"}
  • {"country":"Bulgaria","full_name":"PPD Bulgaria EOOD","duties_or_roles":"PV-Pharmacovigilance (Argus)/SAE Processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Sponsor duties codes: 1,10,12,2,5","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"IP Vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"PPD Global Central Labs (duplicate entry for APAC)","duties_or_roles":"Interim storage for non-safety samples and PBMC/BMMC/DNA processing, long-term storage for APAC Region","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Invivoscribe Inc. (duplicate)","duties_or_roles":"Central Lab Processing Vendor NPM1 Biomarker during treatment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc. (duplicate)","duties_or_roles":"Central Lab Processing Vendor NPM1 Biomarker for Screening Only","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Revumenib
Active Substance
REVUMENIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 1)
Orphan Designation
Yes
Investigational Product Name
Placebo for Revumenib tablets
Modality
Other
Combination Treatment
Yes

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