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New combo pill and injection aims to control leukemia in frail patients

NCT ID NCT05907057

Recruiting now Disease control Sponsor: Servier Affaires Médicales Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a combination of two drugs—ivosidenib (a daily pill) and azacitidine (an injection or infusion)—in adults newly diagnosed with a type of acute myeloid leukemia (AML) that has an IDH1 gene mutation. The participants are not healthy enough for standard intensive chemotherapy. The main goal is to check the safety and side effects of the combination, but researchers will also see if it helps control the cancer. About 245 people will take part.

What this could mean

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

Active substance
ivosidenib and azacitidine
What this could lead to
If it works, this could offer a safer, effective treatment option for older or frail adults with a specific type of AML who cannot tolerate standard chemotherapy.
What could go wrong
This is an early-phase safety study, not a large confirmatory trial. The combination may still cause serious side effects, and it is not expected to cure the disease—ongoing treatment is likely needed.

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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 (AML)

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AKH - Medizinische Universität Wien

    COMPLETED

    Vienna, 1090, Austria

  • Amsterdam UMC

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

    RECRUITING

    Perugia, 06135, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    RECRUITING

    Brescia, 25123, Italy

  • CHU Angers - Hôpital Hôtel Dieu

    NOT_YET_RECRUITING

    Angers, Liore, 49100, France

  • CHU CAEN - Hôpital de la Côte de Nacre

    RECRUITING

    Caen, Calvados, 14033, France

  • CHU Rennes - Hopital Pontchaillou

    NOT_YET_RECRUITING

    Rennes, Ille Et Vilaine, 35033, France

  • CHU de Toulouse pt

    RECRUITING

    Toulouse, Haute Garonne, 31059, France

  • IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

    RECRUITING

    Meldola, Forli-Cesena, 47014, Italy

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, Bouches-du-Rhône, 13273, France

  • Klinikum Wels-Grieskirchen GmbH

    COMPLETED

    Wels, 4600, Austria

  • Meander Medisch Centrum

    RECRUITING

    Amersfoort, 3818 AZ, Netherlands

  • Rijnstate

    NOT_YET_RECRUITING

    Arnhem, 6815 AD, Netherlands

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

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