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Be Part of Research - Trial Details - Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy

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

Medical Conditions

Acute Myeloid Leukemia


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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'.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2025 Dec 2028

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : day 1-28 per cycle

Intervention Arm Group : Experimental: Venetoclax;

Intervention Type : DRUG
Intervention Description : day 1-28 per cycle

Intervention Arm Group : Placebo comparator: Venetoclax-placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • UK-Birmingham-QE
    Birmingham
  • UK-Blackpool-BLACKPOOLVICTORIA
    Blackpool
  • UK-Bristol-BRISTOLCENTRE
    Bristol
  • UK-Cardiff-UHW
    Cardiff
  • UK-Glasgow-BEATSON
    Glasgow
  • UK-Leeds-STJAMESUH
    Leeds
  • UK-Leicester-LEICESTERRI
    Leicester
  • UK-London-KCH
    London
  • UK-London-ROYALMARSDEN
    London
  • UK-London-UNICOLLEGEHOSP
    London
  • UK-Manchester-CHRISTIE
    Manchester
  • UK-Manchester-ROYALINFIRMARY
    Manchester
  • UK-Newcastle on Tyne-FREEMAN
    Newcastle upon Tyne
  • UK-Nottingham-NOTTINGHAMCH
    Nottingham
  • UK-Oxford-CHURCHILL
    Oxford
  • UK-Portsmouth-QUEENALEXANDRA
    Portsmouth
  • UK-Southampton-SOUTHAMPTONGH
    Southampton
  • UK-Wolverhampton-NEWCROSSH
    Wolverhampton


The study is sponsored by Stichting Hemato-Oncologie voor Volwassenen Nederland and is in collaboration with German-Austrian Acute Myeloid Leukemia Study Group; United Kingdom AML Research Network; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA); 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.




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Read full details for Trial ID: NCT07075016
Last updated 13 August 2025

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