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

NCT ID NCT05907057

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 245 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has untreated Acute Myeloid Leukemia (AML) * Have a documented IDH1 R132 gene-mutated disease * Have at least one of the following making yourself ineligible for intensive chemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2, or any comorbidity that the investigator judges to be incompatible with IC including but not limited to severe cardiac or pulmonary disorder, creatinine clearance less than 45 mL/minute, or bilirubin greater than 1.5 times the upper limit of normal * Has adequate hepatic (liver) and renal (kidney) function * Female participants of reproductive potential must have a negative blood pregnancy test and must use effective contraception during treatment and for at least 6 months following treatment * Fertile male participants with female partners of reproductive potential must use effective contraception during treatment and for at least 3 months following treatment Exclusion Criteria: * Has received any prior treatment for AML, with the exception of hydroxyurea or leukapheresis for white blood cell count control * Has received prior treatment with an IDH1 inhibitor * Is a woman who is pregnant or breastfeeding * Has an active, uncontrolled, systemic fungal, bacterial, or viral infection (including human immunodeficiency virus \[HIV\], active hepatitis B (HBV), or hepatitis C virus \[HCV\]) without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment * Has had significant active cardiac disease within 6 months prior to the start of study treatment, including Class III or IV congestive heart failure, myocardial infarction (heart attack), unstable angina (chest pain), and/or stroke * Has dysphagia (difficulty swallowing), short-gut syndrome, gastroparesis (stomach paralysis), or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs * Has uncontrolled hypertension (high blood pressure)

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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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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