RecruitingPhase 3NCT07075016

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

Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Enrollment

227 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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'.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — ivosidenib, azacitidine, and venetoclax — in patients with newly diagnosed acute myeloid leukemia (AML) or a related blood disorder (MDS/AML) who have a specific gene mutation called IDH1 and are not able to tolerate intensive chemotherapy. **You may be eligible if...** - You have a newly diagnosed IDH1-mutated AML or MDS/AML confirmed by genetic testing - You are 18 years or older (no upper age limit) - You are considered ineligible for intensive chemotherapy due to age (75+), health conditions, or other medical reasons - Your heart, liver, and kidneys are functioning at acceptable levels **You may NOT be eligible if...** - You have already received treatment for AML (certain prior treatments may disqualify you) - You have another form of AML with specific mutations that qualify you for a different trial at your site - Your organ function is too poor for this treatment combination Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax 400

day 1-28 per cycle

DRUGPlacebo

day 1-28 per cycle

Locations(119)

AT-Feldkirch-IKHF

Feldkirch, Austria

AT-Salzburg-SALK

Salzburg, Austria

AT-Vienna-HANUSCH

Vienna, Austria

BE-Antwerpen-ZAS

Antwerp, Belgium

BE-Brussel-BORDET

Brussels, Belgium

BE-Brussel-UZBRUSSEL

Brussels, Belgium

BE-Bruxelles-STLUC

Brussels, Belgium

BE-Gent-UZGENT

Ghent, Belgium

BE-Leuven-UZLEUVEN

Leuven, Belgium

BE-Liege-CHULIEGE

Liège, Belgium

BE-Yvoir-MONTGODINNE

Yvoir, Belgium

DK-Aalborg-AALBORGUH

Aalborg, Denmark

DK-Aarhus N-AUH

Aarhus N, Denmark

DK-Copenhagen-RIGSHOSPITALET

Copenhagen, Denmark

DK-Odense-OUH

Odense, Denmark

DK-Roskilde-ROSKILDE

Roskilde, Denmark

EE-Tallinn-REGIONAALHAIGLA

Tallinn, Estonia

EE-Tartu-TARTU

Tartu, Estonia

FI-Helsinki-HUS

Helsinki, Finland

FI-Tampere-TAYS

Tampere, Finland

FR-Angers-CHUANGERS

Angers, France

FR-Pessac Cedex-CHUBORDEAUX

Bordeaux, France

FR-Caen-CHUCAEN

Caen, France

FR-Créteil cedex-CHUMONDOR

Créteil, France

FR-Grenoble cedex 9-CHUGRENOBLE

Grenoble, France

FR-Lille-CHULILLE

Lille, France

FR-Lyon Pierre Benite cedex-LYONSUD

Lyon, France

FR-Montpellier-CHUSAINTELOIS

Montpellier, France

FR-Nantes-CHUNANTES

Nantes, France

FR-Nice-LARCHET

Nice, France

FR-Rennes cedex 9-CHURENNES

Rennes, France

FR-Rouen cedex-BECQUEREL

Rouen, France

FR-Saint-Priest-en-Jarez-STETIENNE

Saint-Etienne, France

FR-Le Chesnay cedex-CHVERSAILLES

Versailles, France

DE-Berlin-CAMPUSBENFRANKLIN

Berlin, Germany

DE-Berlin-CAMPUSVIRCHOW

Berlin, Germany

DE-Berlin-VIVANTESNEUKOLLN

Berlin, Germany

DE-Bochum-RUB

Bochum, Germany

DE-Bonn-UNIBONN

Bonn, Germany

DE-Braunschweig-KLINIKUMBRAUNSCHWEIG

Braunschweig, Germany

DE-Bremen-KBM

Bremen, Germany

DE-Darmstadt-KLINIKUMDARMSTADT

Darmstadt, Germany

DE-Flensburg-MALTESER

Flensburg, Germany

DE-Freiburg-UNIKLINIKFREIBURG

Freiburg im Breisgau, Germany

DE-Greifswald-UNIGREIFSWALD

Greifswald, Germany

DE-Halle-UMH

Halle, Germany

DE-Hamburg-ASKLEPIOSSTGEORG

Hamburg, Germany

DE-Hamburg-UKE

Hamburg, Germany

DE-Hannover-MHHANNOVER

Hanover, Germany

DE-Hannover-SILOAHKRH

Hanover, Germany

DE-Heilbronn-SLK

Heilbronn, Germany

DE-Karlsruhe-KLINIKUMKARLSRUHE

Karlsruhe, Germany

DE-Mainz-UNIMEDIZINMAINZ

Mainz, Germany

DE-Minden-MUEHLENKREISKLINKEN

Minden, Germany

DE-München-IRZTUM

München, Germany

DE-Oldenburg-KLINIKUMOLDENBURG

Oldenburg, Germany

DE-Regensburg-UKR

Regensburg, Germany

DE-Stuttgart-KLINIKUMSTUTTGART

Stuttgart, Germany

DE-Tübingen-MEDUNITUEBINGEN

Tübingen, Germany

DE-Ulm-UNIKLINKULM

Ulm, Germany

IE-Cork-CUH

Cork, Ireland

IE-Dublin 7-MATER

Dublin, Ireland

IE-Dublin 8-ST JAMES

Dublin, Ireland

IE-Galway-UHGALWAY

Galway, Ireland

IT-Bologna-MALPHIGI

Bologna, Italy

IT-Milano-NIGUARDA

Milan, Italy

IT-Roma-SAPIENZA

Roma, Italy

IT-Roma-TORVERGATA

Roma, Italy

IT-Torino-CITTADELLASALUTE

Torino, Italy

LT-Vilnius-SANTA

Vilnius, Lithuania

NL-Den Bosch-JBZ

's-Hertogenbosch, Netherlands

NL-Amsterdam-VUMC

Amsterdam, Netherlands

NL-Arnhem-RIJNSTATE

Arnhem, Netherlands

NL-Breda-AMPHIA

Breda, Netherlands

NL-Dordrecht-ASZ

Dordrecht, Netherlands

NL-Eindhoven-CATHARINA

Eindhoven, Netherlands

NL-Enschede-MST

Enschede, Netherlands

NL-Sittard-Geleen-ZUYDERLAND

Geleen, Netherlands

NL-Groningen-UMCG

Groningen, Netherlands

NL-Nijmegen-RADBOUDUMC

Nijmegen, Netherlands

NL-Rotterdam-ERASMUSMC

Rotterdam, Netherlands

NL-DenHaag-HAGA

The Hague, Netherlands

NL-Utrecht-UMCU

Utrecht, Netherlands

NL-Zwolle-ISALA

Zwolle, Netherlands

NO-Bergen-HELSEBERGEN

Bergen, Norway

NO-Oslo-OSLOUH

Oslo, Norway

NO-Tromsø-NORTHNOORWEGEN

Tromsø, Norway

NO-Trondheim-STOLAV

Trondheim, Norway

ES-Barcelona-CLINICUB

Barcelona, Spain

ES-Barcelona-GERMANTRIALS

Barcelona, Spain

ES-Barcelona-SANTPAU

Barcelona, Spain

ES-Girona-ICSTRUETA

Girona, Spain

ES-Valencia-MALVARROSA

Valencia, Spain

SE-Goteborg-SAHLGRENSKA

Gothenburg, Sweden

SE-Lund-SUH

Lund, Sweden

SE-Stockholm-KAROLINSKAHUDDINGE

Stockholm, Sweden

SE-Uppsala-UPPSALAUH

Uppsala, Sweden

CH-Basel-USB

Basel, Switzerland

CH-Bellinzona-IOSI

Bellinzona, Switzerland

CH-Bern-INSEL

Bern, Switzerland

CH-Zurich-USZ

Zurich, Switzerland

UK-Birmingham-QE

Birmingham, United Kingdom

UK-Blackpool-BLACKPOOLVICTORIA

Blackpool, United Kingdom

UK-Bristol-BRISTOLCENTRE

Bristol, United Kingdom

UK-Cardiff-UHW

Cardiff, United Kingdom

UK-Glasgow-BEATSON

Glasgow, United Kingdom

UK-Leeds-STJAMESUH

Leeds, United Kingdom

UK-Leicester-LEICESTERRI

Leicester, United Kingdom

UK-London-KCH

London, United Kingdom

UK-London-ROYALMARSDEN

London, United Kingdom

UK-London-UNICOLLEGEHOSP

London, United Kingdom

UK-Manchester-CHRISTIE

Manchester, United Kingdom

UK-Manchester-ROYALINFIRMARY

Manchester, United Kingdom

UK-Newcastle on Tyne-FREEMAN

Newcastle upon Tyne, United Kingdom

UK-Nottingham-NOTTINGHAMCH

Nottingham, United Kingdom

UK-Oxford-CHURCHILL

Oxford, United Kingdom

UK-Portsmouth-QUEENALEXANDRA

Portsmouth, United Kingdom

UK-Southampton-SOUTHAMPTONGH

Southampton, United Kingdom

UK-Wolverhampton-NEWCROSSH

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07075016

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