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Study identifier: NCT07478991 Synced from ClinicalTrials.gov · August 03, 2026
● Recruiting

Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)

Condition: Acute Myeloid Leukemia, Adult  ·  Sponsor: PETHEMA Foundation

PhasePhase 3
Planned participants376
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this clinical trial is to learn if Venetoclax+Azacytidine+Quizartinib works better than standard therapy (Venetoclax+Azacytdine) to treat naïve adult patients with acute myeloid leukemia (AML) who are not suitable for standard induction therapy due to age, co-morbidities or other risk factors. The main question it aims to answer is: \- Does the combination of Venetoclax+Azacytidine+Quizartinib show more probability of overall survival than Venetoclax+Azacytdine? Researchers will compare Venetoclax+Azacytidine+Quizartinib to Venetoclax+Azacytdine to see if Venetoclax+Azacytidine+Quizartinib works better than Venetoclax+Azacytdine to treat AML. Participants will be randomized to one of the two treatment arms in a 1:1 ratio, both of which will have treatment cycles of 28 days.

This description comes directly from the study's public registry record.

Talk to the study team

Pau Montesinos  ·  +3461244925  ·  montesinos_pau@gva.es

Juan José Lahuerta  ·  +34916266232  ·  jjlahuerta@telefonica.net

Always discuss trial participation with your own doctor first.

Locations (51)

Complejo Hospitalario Universitario de A CoruñaSantiago de Compostela, A Coruña, SpainNot Yet Recruiting
ICO Hospitalet- Hospital Duran i ReynalsHospitalet Del Llobregat, Barcelona, SpainRecruiting
Hospital Mútua de TerrassaTerrassa, Barcelona, SpainNot Yet Recruiting
Complejo Hospitalario de JaénJaén, Jaen, SpainNot Yet Recruiting
Hospital Principe de AsturiasAlcalá de Henares, Madrid, SpainNot Yet Recruiting
Hospital Universitario Infanta SofíaSan Sebastián de los Reyes, Madrid, SpainNot Yet Recruiting
Hospital Regional Universitario de MálagaMálaga, Malaga, SpainNot Yet Recruiting
Hospital Universitario de CrucesBarakaldo, Vizcaya, SpainNot Yet Recruiting
Complejo Hospitalario de AlbaceteAlbacete, SpainNot Yet Recruiting
Hospital General Universitario Dr. BalmisAlicante, SpainNot Yet Recruiting
Hospital Universitario TorrecárdenasAlmería, SpainNot Yet Recruiting
Institut Catalá d´Oncología (ICO Badalona)Badalona, SpainNot Yet Recruiting

+ 39 more locations — full list on the registry record.

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