Clinical trial • Phase III • Oncology

Revumenib for Acute myeloid leukemia

Phase III trial of Revumenib for Acute myeloid leukemia. 54 participants.

Overview

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

Key dates

Initial CTIS Submission Date
22-10-2024
First CTIS Authorization Date
03-02-2025

Trial design

Phase III trial across 10 sites in Netherlands, Spain.

Target Sample Size
54

Recruitment

Planned Sample Size
54
Recruitment Window Months
51

Geography

Total Number Of Sites
10
Total Number Of Participants
22

Netherlands

Earliest CTIS Part Ii Submission Date
10-01-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
474
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hematology
Principal Investigator Name
Anna van Rhenen
Principal Investigator Email
a.vanrhenen@umcutrecht.nl
Contact Person Name
Anna van Rhenen
Contact Person Email
a.vanrhenen@umcutrecht.nl

Spain

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
509
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Mi Kwon
Principal Investigator Email
mi.kwon@salud.madrid.org
Contact Person Name
Mi Kwon
Contact Person Email
mi.kwon@salud.madrid.org
Site Name
Hospital Clinic De Barcelona
Department Name
Hematolgy
Principal Investigator Name
Jordi Esteve Reyner
Principal Investigator Email
jesteve@clinic.cat
Contact Person Name
Jordi Esteve Reyner
Contact Person Email
jesteve@clinic.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Eduardo Rodríguez Arbolí
Principal Investigator Email
edurodarb@gmail.com
Contact Person Name
Eduardo Rodríguez Arbolí
Contact Person Email
edurodarb@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Guillermo Martín Sánchez
Principal Investigator Email
guimartin@humv.es
Contact Person Name
Guillermo Martín Sánchez
Contact Person Email
guimartin@humv.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Pilar Martínez Sánchez
Contact Person Name
Pilar Martínez Sánchez
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Maria Belén Vidriales Vicente
Principal Investigator Email
mbvidri@usal.es
Contact Person Name
Maria Belén Vidriales Vicente
Contact Person Email
mbvidri@usal.es
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Hematology
Principal Investigator Name
Pedro Antonio Gonzalez Sierra
Principal Investigator Email
pedroa.gonzalez.sspa@juntadeandalucia.es
Contact Person Name
Pedro Antonio Gonzalez Sierra
Site Name
Hospital San Pedro De Alcantara
Department Name
Hematology
Principal Investigator Name
Juan Miguel Bergua Burgés
Principal Investigator Email
juanmiguel.bergua@salud-juntaex.es
Contact Person Name
Juan Miguel Bergua Burgés
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Pau Montesinos Fernández
Principal Investigator Email
montesinos_pau@gva.es
Contact Person Name
Pau Montesinos Fernández
Contact Person Email
montesinos_pau@gva.es

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
Revumenib
Active Substance
Revumenib
Modality
Small molecule
Combination Treatment
Yes

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