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

Study acronym: DECISIVO
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 4 more changesShow less
    • Trial sites expanded: 15 → 20 locations
    • Interventions: Allogeneic stem cell transplantation (Procedure), Cytarabine (Drug), Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET (Drug), Hydroxyurea… to Allogeneic stem cell transplantation (Procedure), Cytarabine (Drug), Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET (Drug), Hydroxyurea…
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Site details revised at 2 of 15 sitesv3
  3. Recruitment opened
    • Start date changed from estimate of Apr 2026 to Jun 12, 2026
    • Site details revised at 15 of 15 sites
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07507760
Lead Sponsor PETHEMA Foundation
Conditions
(from sponsor)		 Acute Myeloid Leukemia With Gene Mutations
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov