New combo aims to boost survival in older AML patients

NCT ID NCT04090736

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

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

Summary

This phase 3 trial compares a two-drug combination (pevonedistat plus azacitidine) against azacitidine alone in 302 older or unfit adults newly diagnosed with acute myeloid leukemia (AML) who cannot have standard intensive chemotherapy. The main goal is to see if the combination improves overall survival. Participants receive treatment in 28-day cycles, and the study is no longer recruiting new patients.

What this could mean

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

Active substance

Pevonedistat combined with azacitidine

What this could lead to

If successful, this combination could offer a new treatment option that improves survival for older or frail patients with acute myeloid leukemia who cannot tolerate standard chemotherapy.

What could go wrong

This is a phase 3 trial, but results are not yet reported. The combination may not improve survival over azacitidine alone and could cause additional side effects. It is not a cure, and patients still need ongoing treatment.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

acute myeloid leukemia leukemia

As listed by the trial registrant

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

LEUKEMIA, MYELOID, ACUTE

Contacts and locations

Show contact details

Locations

Complejo Asistencial de Ávila

Ávila, Spain
Complejo Hospitalario Lucus Augusti

Lugo, Spain
Complejo Hospitalario Regional Reina Sofía

Córdoba, 14004, Spain
Complejo Hospitalario Torrecárdenas

Almería, 04004, Spain
Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain
Complejo Hospitalario Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, 38010, Spain
Complejo Hospitalario Universitario de Albacete

Albacete, 02006, 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 de Cáceres

Cáceres, 10003, Spain
Complejo Hospitalario de Jaén

Jaén, Jaen, 23007, Spain
Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain
Complexo Hospitalario de Pontevedra

Pontevedra, 36071, Spain
Hospital Clínico San Carlos

Madrid, 28040, Spain
Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain
Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain
Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain
Hospital Dr. José Molina Orosa

Arrecife, Spain
Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain
Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain
Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30200, Spain
Hospital General Universitario de Alicante

Alicante, 03010, Spain
Hospital General Universitario de Castellón

Castelló, Spain
Hospital General Universitario de Elche

Elche, Spain
Hospital General de Segovia

Segovia, Spain
Hospital Quirón de Málaga

Málaga, Spain
Hospital Regional Universitario de Málaga

Málaga, Malaga, 29010, Spain
Hospital San Agustin

Avilés, Spain
Hospital San Jorge

Huesca, Spain
Hospital Son Llàtzer

Palma de Mallorca, Spain
Hospital Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain
Hospital Universitari Joan XXIII

Tarragona, 43005, Spain
Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain
Hospital Universitario Donostia

San Sebastián, Guipuzcoa, Spain
Hospital Universitario Dr. Peset Aleixandre

Valencia, 46017, Spain
Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain
Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Universitario Juan Ramón Jiménez

Huelva, 21005, Spain
Hospital Universitario Madrid Norte Sanchinarro

Madrid, 28050, Spain
Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain
Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain
Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain
Hospital Universitario Virgen del Rocío

Seville, Sevila, 41013, Spain
Hospital Universitario de Badajoz

Badajoz, 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, Spain
Hospital Universitario de Cruces

Barakaldo, Vizcaya, 48903, Spain
Hospital Universitario de Galdakao

Galdakao, Vizcaya, 48960, Spain
Hospital Universitario de Guadalajara

Guadalajara, Spain
Hospital Universitario de Salamanca

Salamanca, 37007, Spain
Hospital Virgen de la Salud

Toledo, Spain
Hospital Vithas Xanit Internacional

Benalmádena, Spain
Hospital de Valme

Seville, Spain
Hospital del Mar

Barcelona, Spain
ICO Badalona- Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain
ICO Girona- Hospital Universitari Dr Josep Trueta

Girona, 17007, Spain
ICO Hospitalet- Hospital Duran i Reynals

Hospitalet Del Llobregat, Barcelona, 08908, Spain