Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients

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

Trial Details

NCT ID
NCT07507760
Phase
PHASE2
Sponsor
PETHEMA Foundation
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET
  • Ivosidenib Oral Tablet
  • Hydroxyurea
  • Cytarabine
  • Allogeneic stem cell transplantation
Locations (sample)
  • Aveiro, Portugal|40.64575,-8.64643
  • Funchal, Portugal|32.66568,-16.92547
  • Lisbon, Portugal|38.72509,-9.1498
  • Lisbon, Portugal|38.72509,-9.1498
  • Porto, Portugal|41.1485,-8.61097

Key Eligibility Criteria

  • Morphological diagnosis of AML (WHO criteria 2022)
  • Newly diagnosed AML.
  • IDH1 R132 mutations (centrally assessed by PCR and NGS). A patient will be allowed to be included with local result after approval of the medical m…
  • Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2 if ≥ 60 years of age, or 0 to 3 if ≥ 18 to 60 years.

For full eligibility, visit ClinicalTrials.gov.

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