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

NCT07075016 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2025-08-19

No results posted yet for this study

Summary

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'.

Conditions

Interventions

DRUG

Venetoclax 400

day 1-28 per cycle

DRUG

Placebo

day 1-28 per cycle

Sponsors & Collaborators

  • German-Austrian Acute Myeloid Leukemia Study Group

    collaborator UNKNOWN

  • United Kingdom AML Research Network

    collaborator UNKNOWN

  • Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA)

    collaborator UNKNOWN

  • Swiss Group for Clinical Cancer Research (SAKK)

    collaborator UNKNOWN

  • Danish Acute Leukemia Group

    collaborator UNKNOWN

  • Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

    collaborator OTHER

  • Nordic AML Group

    collaborator UNKNOWN

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07075016 on ClinicalTrials.gov