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New pill combo aims to improve AML treatment in Non-FLT3 patients

NCT ID NCT04107727

Completed Disease control Sponsor: PETHEMA Foundation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding the targeted drug quizartinib to standard chemotherapy helps adults with newly diagnosed acute myeloid leukemia (AML) that does not have a FLT3 mutation. 273 patients were randomly assigned to receive either quizartinib or a placebo alongside their chemo. The study looked at how long patients stayed free of leukemia-related events and how well they tolerated the treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Quizartinib (a targeted cancer drug taken as a pill)
What this could lead to
If successful, this could provide a new treatment option for people with a common type of AML that lacks the FLT3 mutation.
What could go wrong
This is a phase 2 trial, so results are still early. The drug may not improve outcomes or could cause side effects. It is also tested only in a specific genetic subgroup.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOID LEUKEMIA

Contacts and locations

Locations

  • Complejo Hospitalario Lucus Augusti

    Lugo, 27003, Spain

  • Complejo Hospitalario Regional Reina Sofía

    Córdoba, 14004, Spain

  • Complejo Hospitalario Regional Virgen del Rocío

    Seville, 41013, Spain

  • Complejo Hospitalario Universitario de A Coruña

    Santiago de Compostela, A Coruña, 15706, Spain

  • Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706, Spain

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36312, Spain

  • Complejo Hospitalario de Albacete

    Albacete, 02006, Spain

  • Complejo Hospitalario de Jaén

    Jaén, 23007, Spain

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36071, Spain

  • Complejo Hospitalario de Toledo

    Toledo, 45004, Spain

  • Complejo Universitario de Navarra

    Pamplona, 31008, Spain

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Clínico Universitario Valencia

    Valencia, 46010, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital General Universitario Santa Lucía

    Cartagena, Murcia, 30200, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital General Univesitario de Castellón

    Castellon, Castellón, 12004, Spain

  • Hospital Juan Ramón Jiménez

    Huelva, 21005, Spain

  • Hospital La Paz

    Madrid, Spain

  • Hospital Nuestra Señora del Prado

    Talavera de la Reina, Spain

  • Hospital Puerta del Mar

    Cadiz, Spain

  • Hospital Ramón y Cajal

    Madrid, Spain

  • Hospital Regional Universitario Málaga

    Málaga, 29010, Spain

  • Hospital San Pedro de Alcántara

    Cáceres, 10003, Spain

  • Hospital Txagorritxu

    Vitoria-Gasteiz, Álava, 01009, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Vall Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, 33006, Spain

  • Hospital Universitario Dr. Peset Aleixandre

    Valencia, 46017, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Quirón Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital Universitario de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • Hospital Universitario de Burgos

    Burgos, 09006, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

  • Hospital Universitario de Galdakao

    Galdakao, Vizcaya, 48960, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Virgen de la Arrixaca

    Murcia, Spain

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