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French study tracks Ivosidenib's Real-World impact on Hard-to-Treat leukemia

NCT ID NCT06377579

Disease control Sponsor: French Innovative Leukemia Organisation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes 250 adults with a specific genetic subtype of acute myeloid leukemia (AML) who received the targeted drug Ivosidenib through a compassionate use program in France. Researchers will track survival and treatment response in patients receiving the drug as a first treatment or after relapse. The goal is to gather real-world evidence on how well Ivosidenib works outside of clinical trials.

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.

Participants

About 250 people

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

Started

Jul 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients of 18 years old or more, with newly diagnosed or relapsed or refractory IDH1 mutated AML according to ELN 2022 and treated with IVO thanks to the CUP between the period 01/01/2017 to 01/08/2023, treated in French AML FILO or ALFA centers

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: * Patient with IDH1 R132 mutated with newly diagnosed or Relapsed or Refractory (R/R) acute myeloid leukemia * Patient treated within French compassionate access program that have started the treatment between 01/01/2017 to 01/08/2023 * patient treated by Ivosidenib received either as a monotherapy or in combination with other AML therapy (i.e. azacytidine, venetoclax) * Patient not included within IDH inhibitor clinical trial. Exclusion Criteria: * Patients who expressed their opposition to entered in the study * Patients who received IVO through a trial

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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.

AML, adult

How to take part

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

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Amiens CHU

    NOT_YET_RECRUITING

    Amiens, France

  • Angers CHU

    NOT_YET_RECRUITING

    Angers, France

  • Bayonne CH

    NOT_YET_RECRUITING

    Bayonne, France

  • Besançon CHU

    NOT_YET_RECRUITING

    Besançon, France

  • Bordeaux CHU

    NOT_YET_RECRUITING

    Pessac, France

  • CHU Estaing

    RECRUITING

    Clermont-Ferrand, France

  • Créteil CHU HENRI MONDOR

    RECRUITING

    Créteil, France

  • DUNKERQUE-Hôpital Alexandra Lepève

    RECRUITING

    Dunkirk, 59385, France

  • Grenoble CHU

    NOT_YET_RECRUITING

    Grenoble, France

  • ICANS - Institut de cancérologie de strasbourg europe

    NOT_YET_RECRUITING

    Strasbourg, France

  • Le Mans CH

    NOT_YET_RECRUITING

    Le Mans, France

  • Lyon sud CHU

    NOT_YET_RECRUITING

    Lyon, France

  • Marseille IPC

    NOT_YET_RECRUITING

    Marseille, France

  • Meaux CH de l'Est francilien

    RECRUITING

    Meaux, France

  • Montpellier - Chu Saint Eloi

    NOT_YET_RECRUITING

    Montpellier, France

  • Mulhouse Chu

    RECRUITING

    Mulhouse, 68100, France

  • Nantes CHU

    RECRUITING

    Nantes, France

  • Nice CHU

    NOT_YET_RECRUITING

    Nice, France

  • Orléans CHU

    NOT_YET_RECRUITING

    Orléans, 45000, France

  • Paris Saint Louis

    NOT_YET_RECRUITING

    Paris, France

  • Toulouse - IUCT Oncopole - Service d'Hématologie

    NOT_YET_RECRUITING

    Toulouse, France

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