Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07075016 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy

Study acronym: EVOLVE 1
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2025 to Aug 5, 2025 · Site details revised at 119 of 119 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2025 to Aug 5, 2025
    • Site details revised at 119 of 119 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 standard treatment for patients with acute myeloid leukemia (AML) with an abnormality in the IDH1 gene, who are not eligible for intensive chemotherapy, is a combination of ivosidenib and azacitidine. In this study it is investigated whether adding venetoclax to the standard treatment can improve the outcome of the treatment of this specific form of AML. The safety is investigated and how well it works. In order to properly assess the value of venetoclax, the effect of venetoclax is compared with the effect of a placebo. A placebo is a product without an active ingredient, a 'fake medicinal product'.
Trial Details
NCT Number NCT07075016
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: German-Austrian Acute Myeloid Leukemia Study Group, United Kingdom AML Research Network, Gruppo Italiano Malattie EMatologiche dell'Adulto, Swiss Group for Clinical Cancer Research (SAKK), Danish Acute Leukemia Group, Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias, Nordic AML Group
Conditions Acute Myeloid Leukemia
Enrollment 227 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov