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Study identifier: NCT05907057 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.

Condition: Acute Myeloid Leukemia (AML)  ·  Sponsor: Servier Affaires Médicales

PhasePhase 3
Planned participants245
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive \[IDH1m\]) and cannot receive treatment with intensive chemotherapy (IC).

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

Talk to the study team

Servier Affaires Médicales  ·  +33 1 55 72 60 00  ·  scientificinformation@servier.com

Always discuss trial participation with your own doctor first.

Locations (15)

AKH - Medizinische Universität WienVienna, AustriaCompleted
Klinikum Wels-Grieskirchen GmbHWels, AustriaCompleted
Institut Paoli CalmettesMarseille, Bouches-du-Rhône, FranceRecruiting
CHU CAEN - Hôpital de la Côte de NacreCaen, Calvados, FranceRecruiting
CHU de Toulouse ptToulouse, Haute Garonne, FranceRecruiting
CHU Rennes - Hopital PontchaillouRennes, Ille Et Vilaine, FranceNot Yet Recruiting
CHU Angers - Hôpital Hôtel DieuAngers, Liore, FranceNot Yet Recruiting
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRSTMeldola, Forli-Cesena, ItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)Brescia, ItalyRecruiting
IRCCS Ospedale Policlinico San MartinoGenova, ItalyRecruiting
Azienda Ospedaliera di Perugia Ospedale S. Maria della MisericordiaPerugia, ItalyRecruiting
Meander Medisch CentrumAmersfoort, NetherlandsRecruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05907057