Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who are older than 18 years old with defined comorbidities that make them not suitable for standard induction therapy. The main objectives of this clinical trial are: * Asses the Complete Remission (CR) and Complete Remission with incomplete marrow recovery (CRi) rates of this treatment. * Determine the incidence and severity of all adverse events (AEs). All participants will receive oral ivosidenib and oral decitabine in treatment cycles of 28 days until disease progression, lack of clinical benefit or the end of the study. Patients who achieve CR/CRi will be elegible to receive allogeneic stem cell transplantation.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Nowo zdiagnozowana ostra białaczka szpikowa (AML).
- •Obecność mutacji IDH1 R132 w komórkach białaczki.
- •Pacjenci w wieku 60 lat lub starsi.
- •Pacjenci w wieku 18-60 lat z dodatkowymi schorzeniami, które sprawiają, że nie mogą przyjmować intensywnego leczenia chemioterapią.
✗ Disqualifies
- •Pacjenci poniżej 18 roku życia.
- •Pacjenci, którzy przeszli już intensywne leczenie chemioterapią z powodu białaczki.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 29, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (15)
Complejo Hospitalario de Albacete
Albacete, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital San Pedro Alcántara
Cáceres, Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, Spain
Hospital Universitario de Canarias
Las Palmas de Gran Canaria, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Fundación Jiménez Díaz
Madrid, Spain
H. 12 de Octubre
Madrid, Spain
Hospital Univeristario Ramón y Cajal
Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen Del Rocío
Seville, Spain
H. Dr. Peset
Valencia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Trial contact
Pau Montesinos
Juan José Lahuerta
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.
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