Can a targeted pill keep leukemia from returning after transplant?
NCT ID NCT06717958
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Locations
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Goethe Universität Frankfurt / Universitätsklinikum Frankfurt
RECRUITINGFrankfurt am Main, Germany
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Klinikum Chemnitz gGmbH
RECRUITINGChemnitz, Germany
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Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
RECRUITINGMünchen, Germany
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Martin-Luther-Universitaet Halle-Wittenberg
RECRUITINGHalle, Germany
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Rostock University Medical Center
RECRUITINGRostock, Germany
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Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I
RECRUITINGDresden, Germany
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Universitaetsklinikum Erlangen AöR
NOT_YET_RECRUITINGErlangen, Germany
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Universitaetsklinikum Ulm
NOT_YET_RECRUITINGUlm, Germany
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University Medical Center Hamburg-Eppendorf
RECRUITINGHamburg, Germany
Contact Email: •••••@•••••
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Universität Leipzig
RECRUITINGLeipzig, Germany
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Universität Münster
RECRUITINGMünster, Germany
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Universitätsklinikum Aachen
RECRUITINGAachen, Germany
Contact Email: •••••@•••••
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Universitätsklinikum Essen
RECRUITINGEssen, Germany
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Universitätsklinikum Jena
RECRUITINGJena, Germany
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Universitätsklinikum Schleswig-Holstein
RECRUITINGKiel, Germany
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Universitätsmedizin Greifswald KöR
RECRUITINGGreifswald, Germany
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Universitätsmedizin der Johannes Gutenberg-Universität Mainz
NOT_YET_RECRUITINGMainz, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Frailty check may steer safer cancer care for seniors
- Can a tailored chemo cocktail outsmart a common leukemia?
- Can new drug cocktails beat back Hard-to-Treat leukemia?
- Can a pill and injection combo beat AML without harsh chemo?
- Can a different immune drug cut viral infections after stem cell transplants?