New combo pill and injection aims to control leukemia in frail patients
NCT ID NCT05907057
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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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.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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AKH - Medizinische Universität Wien
COMPLETEDVienna, 1090, Austria
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Amsterdam UMC
RECRUITINGAmsterdam, 1105 AZ, Netherlands
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Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
RECRUITINGPerugia, 06135, Italy
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
RECRUITINGBrescia, 25123, Italy
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CHU Angers - Hôpital Hôtel Dieu
NOT_YET_RECRUITINGAngers, Liore, 49100, France
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CHU CAEN - Hôpital de la Côte de Nacre
RECRUITINGCaen, Calvados, 14033, France
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CHU Rennes - Hopital Pontchaillou
NOT_YET_RECRUITINGRennes, Ille Et Vilaine, 35033, France
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CHU de Toulouse pt
RECRUITINGToulouse, Haute Garonne, 31059, France
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IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST
RECRUITINGMeldola, Forli-Cesena, 47014, Italy
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IRCCS Ospedale Policlinico San Martino
RECRUITINGGenova, 16132, Italy
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Institut Paoli Calmettes
RECRUITINGMarseille, Bouches-du-Rhône, 13273, France
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Klinikum Wels-Grieskirchen GmbH
COMPLETEDWels, 4600, Austria
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Meander Medisch Centrum
RECRUITINGAmersfoort, 3818 AZ, Netherlands
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Rijnstate
NOT_YET_RECRUITINGArnhem, 6815 AD, Netherlands
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Universitair Medisch Centrum Groningen
RECRUITINGGroningen, 9713 GZ, Netherlands