Can a targeted pill keep leukemia from returning after transplant?

NCT ID NCT06717958

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This phase II trial is testing whether the drug ivosidenib, taken as a pill, can help prevent relapse in people with acute myeloid leukemia (AML) or myelodysplastic neoplasia (MDS) who have an IDH1 mutation and have recently undergone a stem cell transplant. Participants will start ivosidenib within 100 days after transplant and continue as maintenance therapy. The main goal is to see if the drug improves event-free survival, meaning how long patients live without the disease coming back or other serious events.

What this could mean

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

Active substance
ivosidenib
What this could lead to
If successful, this could offer a way to keep AML or MDS from returning after a stem cell transplant, potentially improving long-term survival.
What could go wrong
This is an early-phase, single-arm trial, so results may not be definitive. Ivosidenib can cause side effects, and its benefit over standard care is not yet proven.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 76 people

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

Started

Jun 2025

Expected to finish

Feb 2030

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.

Ages

18 to 75 years

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 criterion: * AML or MDS with IDH1 mutation Exclusion criteria: * active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids \>1mg/ kg prednisolone equivalent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    17 sites. 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

Locations

  • Goethe Universität Frankfurt / Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt am Main, Germany

  • Klinikum Chemnitz gGmbH

    RECRUITING

    Chemnitz, Germany

  • Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

    RECRUITING

    München, Germany

  • Martin-Luther-Universitaet Halle-Wittenberg

    RECRUITING

    Halle, Germany

  • Rostock University Medical Center

    RECRUITING

    Rostock, Germany

  • Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I

    RECRUITING

    Dresden, Germany

  • Universitaetsklinikum Erlangen AöR

    NOT_YET_RECRUITING

    Erlangen, Germany

  • Universitaetsklinikum Ulm

    NOT_YET_RECRUITING

    Ulm, Germany

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

    Contact Email: •••••@•••••

  • Universität Leipzig

    RECRUITING

    Leipzig, Germany

  • Universität Münster

    RECRUITING

    Münster, Germany

  • Universitätsklinikum Aachen

    RECRUITING

    Aachen, Germany

    Contact Email: •••••@•••••

  • Universitätsklinikum Essen

    RECRUITING

    Essen, Germany

  • Universitätsklinikum Jena

    RECRUITING

    Jena, Germany

  • Universitätsklinikum Schleswig-Holstein

    RECRUITING

    Kiel, Germany

  • Universitätsmedizin Greifswald KöR

    RECRUITING

    Greifswald, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    NOT_YET_RECRUITING

    Mainz, Germany

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