Interventional Recruiting Phase 3
NCT07075016 on ClinicalTrials.gov
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
- Collaborators: 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
- Enrollment: 227 (Estimated)
- Study start: 2025-08-05 (Actual)
- Primary completion: 2028-12-01 (Estimated)
- Study completion: 2029-03-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Single Group
- Masking: Triple (Participant, Care Provider, Investigator)
- PrimaryPurpose: Treatment
Brief 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
- Acute Myeloid Leukemia
Intervention / Treatment
- Drug: Venetoclax 400
- Drug: Placebo
Primary Outcome Measures
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Event-free survival (EFS) in patients with newly diagnosed IDH1-mutated AML ineligible for intensive chemotherapy
(12 months after inclusion of last AML patient)
Event-free survival (EFS) in patients with newly diagnosed IDH1-mutated AML ineligible for intensive chemotherapy, measured from the date of randomization to the date of treatment failure, hematologic relapse from CR/CRh or death from any cause, whichever occurs first. Treatment failure is defined as lack of obtaining either CR or CRh by week 24. Patients evaluable for response but not achieving CR or CRh by week 24 will be considered a treatment failure at day 1 post randomization to avoid ambiguities of variable or prolonged periods without response. Patients who die before week 24 without response assessments will also be considered treatment failures at day 1 post randomization. Patients who are alive but not evaluable for response will be censored at day 1 post randomization. Patients who achieved CR or CRh by week 24 and are not known to have morphologic relapse or died will be censored at the date of the last clinical assessment.
Countries
Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Lithuania, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom
Locations and Investigators
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AT-Feldkirch-IKHF, Feldkirch, Austria (Not yet recruiting)
- Dr Bernd Hartmann
- AT-Salzburg-SALK, Salzburg, Austria (Not yet recruiting)
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AT-Vienna-HANUSCH, Vienna, Austria (Not yet recruiting)
- Dr Dr.Elisabeth Koller
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BE-Antwerpen-ZAS, Antwerpen, Belgium (Not yet recruiting)
- Dr Heyrman
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BE-Brussel-BORDET, Brussel, Belgium (Not yet recruiting)
- Dr. Sebastian Wittnebel
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BE-Brussel-UZBRUSSEL, Brussel, Belgium (Not yet recruiting)
- Dr Ann de Becker
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BE-Bruxelles-STLUC, Bruxelles, Belgium (Not yet recruiting)
- Dr Havelange
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BE-Gent-UZGENT, Gent, Belgium (Not yet recruiting)
- Dr Delie
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BE-Leuven-UZLEUVEN, Leuven, Belgium (Not yet recruiting)
- Dr Maertens
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BE-Liege-CHULIEGE, Liege, Belgium (Not yet recruiting)
- Dr DeVoeght
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BE-Yvoir-MONTGODINNE, Yvoir, Belgium (Recruiting)
- Dr Collinge
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DK-Aalborg-AALBORGUH, Aalborg, Denmark (Not yet recruiting)
- Dr Marianne Tang Severinsen
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DK-Aarhus N-AUH, Aarhus N, Denmark (Not yet recruiting)
- Dr Hans Beier Ommen
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DK-Copenhagen-RIGSHOSPITALET, Copenhagen, Denmark (Not yet recruiting)
- Dr Claudia Schöllkopf
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DK-Odense-OUH, Odense, Denmark (Not yet recruiting)
- Dr Claus Marcher
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DK-Roskilde-ROSKILDE, Roskilde, Denmark (Not yet recruiting)
- Dr. Jack Maibom
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EE-Tallinn-REGIONAALHAIGLA, Tallinn, Estonia (Not yet recruiting)
- Dr Katrin Palk
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EE-Tartu-TARTU, Tartu, Estonia (Not yet recruiting)
- Dr Ain Kaare
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FI-Helsinki-HUS, Helsinki, Finland (Not yet recruiting)
- Dr Mika Kontro
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FI-Tampere-TAYS, Tampere, Finland (Not yet recruiting)
- Dr Johanna Rimpilainen
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FR-Angers-CHUANGERS, Angers, France (Not yet recruiting)
- Dr Mathilde Hunault-Berger
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FR-Pessac Cedex-CHUBORDEAUX, Bordeaux, France (Not yet recruiting)
- Dr Pierre-Yves Dumas
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FR-Caen-CHUCAEN, Caen, France (Not yet recruiting)
- Dr Sylvain Chantepie
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FR-Créteil cedex-CHUMONDOR, Créteil, France (Not yet recruiting)
- Dr Mathieu Leclerc
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FR-Grenoble cedex 9-CHUGRENOBLE, Grenoble, France (Not yet recruiting)
- Dr Martin Carre
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FR-Lille-CHULILLE, Lille, France (Not yet recruiting)
- Dr Céline Berthon
- FR-Lyon Pierre Benite cedex-LYONSUD, Lyon, France (Not yet recruiting)
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FR-Montpellier-CHUSAINTELOIS, Montpellier, France (Not yet recruiting)
- Dr Ludovic Gabellier
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FR-Nantes-CHUNANTES, Nantes, France (Not yet recruiting)
- Dr Pierre Peterlin
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FR-Nice-LARCHET, Nice, France (Not yet recruiting)
- Dr Thomas Cluzeau
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FR-Rennes cedex 9-CHURENNES, Rennes, France (Not yet recruiting)
- Dr Tony Marchand
- FR-Rouen cedex-BECQUEREL, Rouen, France (Not yet recruiting)
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FR-Saint-Priest-en-Jarez-STETIENNE, St Etienne, France (Not yet recruiting)
- Dr Emmanuelle Tavernier
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FR-Le Chesnay cedex-CHVERSAILLES, Versailles, France (Not yet recruiting)
- Dr Juliette Lambert
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DE-Berlin-CAMPUSBENFRANKLIN, Berlin, Germany (Not yet recruiting)
- Dr Jörg Westermann
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DE-Berlin-CAMPUSVIRCHOW, Berlin, Germany (Not yet recruiting)
- Dr Jörg Westermann
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DE-Berlin-VIVANTESNEUKOLLN, Berlin, Germany (Not yet recruiting)
- Prof. Dr. Maike de Wit
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DE-Bochum-RUB, Bochum, Germany (Not yet recruiting)
- Dr Prof. Roland Schroers
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DE-Bonn-UNIBONN, Bonn, Germany (Not yet recruiting)
- Dr Lino Teichman
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DE-Braunschweig-KLINIKUMBRAUNSCHWEIG, Braunschweig, Germany (Not yet recruiting)
- Dr Carsten Springer
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DE-Bremen-KBM, Bremen, Germany (Not yet recruiting)
- Prof. Dr. med. B. Hertenstein
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DE-Darmstadt-KLINIKUMDARMSTADT, Darmstadt, Germany (Not yet recruiting)
- Dr Helga Bernhard
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DE-Flensburg-MALTESER, Flensburg, Germany (Not yet recruiting)
- Dr N. Faber
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DE-Freiburg-UNIKLINIKFREIBURG, Freiburg, Germany (Not yet recruiting)
- Prof. Dr. med Michael Lübbert
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DE-Greifswald-UNIGREIFSWALD, Greifswald, Germany (Not yet recruiting)
- Prof. Dr. Adrian Schwarzer
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DE-Halle-UMH, Halle, Germany (Not yet recruiting)
- Dr Michael Heuser
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DE-Hamburg-ASKLEPIOSSTGEORG, Hamburg, Germany (Not yet recruiting)
- Prof. Dr. med. Ahmet Elmaagaclı
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DE-Hamburg-UKE, Hamburg, Germany (Not yet recruiting)
- Dr Franziska Modemann
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DE-Hannover-MHHANNOVER, Hannover, Germany (Not yet recruiting)
- Dr Felicitas Thol
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DE-Hannover-SILOAHKRH, Hannover, Germany (Not yet recruiting)
- Dr. Daniela Dörfel
And 69 other sites.