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
- Principal Investigator Email
- mariapilar.martinez.sanchez@salud.madrid.org
- Contact Person Name
- Pilar Martínez Sánchez
- Contact Person Email
- mariapilar.martinez.sanchez@salud.madrid.org
- 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
- Contact Person Email
- pedroa.gonzalez.sspa@juntadeandalucia.es
- 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
- Contact Person Email
- juanmiguel.bergua@salud-juntaex.es
- 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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