Actively Recruiting
Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2025-08-19
227
Participants Needed
119
Research Sites
186 weeks
Total Duration
On this page
Sponsors
S
Stichting Hemato-Oncologie voor Volwassenen Nederland
Lead Sponsor
G
German-Austrian Acute Myeloid Leukemia Study Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed IDH1-mutated AML or IDH1-mutated MDS/AML according to 2022 classification
- Central confirmation of IDH1 mutation from a designated genetic laboratory
- Age 18 years or older, no upper age limit
- Ineligible for intensive chemotherapy due to age (≥75 years) or specific health conditions including ECOG status, heart issues, lung function, kidney function, liver function, or other comorbidities
- Projected life expectancy of at least 12 weeks
- White blood cell count less than 25 x 10^9/L (hydroxyurea allowed to reduce counts)
- Adequate kidney function (serum creatinine ≤2.0 x ULN or creatinine clearance >30 mL/min)
- Adequate liver function with specific bilirubin and enzyme limits unless due to Gilbert's disease or leukemic involvement
- Female patients must be either non-childbearing or agree to pregnancy prevention measures during and for 6 months after treatment
- Male patients must use contraception and agree to avoid fathering a child during and for 6 months after treatment
- Able and willing to provide informed consent
- Institutional review board/ethics committee approved consent obtained before study procedures
You will not qualify if you...
- Prior treatment for AML except hydroxyurea to control white blood cells
- Acute promyelocytic leukemia with specific genetic translocations
- AML with BCR-ABL1 or myeloid blast crisis of chronic myeloid leukemia
- Significant active cardiac disease within 3 months before study including severe heart failure, recent heart attack, unstable angina, severe arrhythmias, or prolonged QT interval
- Family history of sudden death or ventricular arrhythmia
- Severe lung disorders
- Stroke or brain bleeding within 6 months before randomization
- Active or known central nervous system leukemia
- Uncontrolled active infections such as hepatitis B, C, or HIV
- Life-threatening leukemia complications like uncontrolled bleeding
- Conditions limiting oral drug intake or absorption
- Active second malignancy unless low risk or treated certain skin or cervical cancers
- Live vaccine within 30 days before study or planned during study
- Severe neurological or psychiatric disorders preventing informed consent
- Contraindications to study drugs or participation in other anti-leukemic trials
- Use of certain medications that cannot be safely changed
- Pregnancy, breastfeeding, or plans to become pregnant during study
- Previous ineligibility for this trial prevents re-entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 119 locations
1
AT-Feldkirch-IKHF
Feldkirch, Austria
Not Yet Recruiting
2
AT-Salzburg-SALK
Salzburg, Austria
Not Yet Recruiting
3
AT-Vienna-HANUSCH
Vienna, Austria
Not Yet Recruiting
4
BE-Antwerpen-ZAS
Antwerp, Belgium
Not Yet Recruiting
5
BE-Brussel-BORDET
Brussels, Belgium
Not Yet Recruiting
6
BE-Brussel-UZBRUSSEL
Brussels, Belgium
Not Yet Recruiting
7
BE-Bruxelles-STLUC
Brussels, Belgium
Not Yet Recruiting
8
BE-Gent-UZGENT
Ghent, Belgium
Not Yet Recruiting
9
BE-Leuven-UZLEUVEN
Leuven, Belgium
Not Yet Recruiting
10
BE-Liege-CHULIEGE
Liège, Belgium
Not Yet Recruiting
11
BE-Yvoir-MONTGODINNE
Yvoir, Belgium
Actively Recruiting
12
DK-Aalborg-AALBORGUH
Aalborg, Denmark
Not Yet Recruiting
13
DK-Aarhus N-AUH
Aarhus N, Denmark
Not Yet Recruiting
14
DK-Copenhagen-RIGSHOSPITALET
Copenhagen, Denmark
Not Yet Recruiting
15
DK-Odense-OUH
Odense, Denmark
Not Yet Recruiting
16
DK-Roskilde-ROSKILDE
Roskilde, Denmark
Not Yet Recruiting
17
EE-Tallinn-REGIONAALHAIGLA
Tallinn, Estonia
Not Yet Recruiting
18
EE-Tartu-TARTU
Tartu, Estonia
Not Yet Recruiting
19
FI-Helsinki-HUS
Helsinki, Finland
Not Yet Recruiting
20
FI-Tampere-TAYS
Tampere, Finland
Not Yet Recruiting
21
FR-Angers-CHUANGERS
Angers, France
Not Yet Recruiting
22
FR-Pessac Cedex-CHUBORDEAUX
Bordeaux, France
Not Yet Recruiting
23
FR-Caen-CHUCAEN
Caen, France
Not Yet Recruiting
24
FR-Créteil cedex-CHUMONDOR
Créteil, France
Not Yet Recruiting
25
FR-Grenoble cedex 9-CHUGRENOBLE
Grenoble, France
Not Yet Recruiting
26
FR-Lille-CHULILLE
Lille, France
Not Yet Recruiting
27
FR-Lyon Pierre Benite cedex-LYONSUD
Lyon, France
Not Yet Recruiting
28
FR-Montpellier-CHUSAINTELOIS
Montpellier, France
Not Yet Recruiting
29
FR-Nantes-CHUNANTES
Nantes, France
Not Yet Recruiting
30
FR-Nice-LARCHET
Nice, France
Not Yet Recruiting
31
FR-Rennes cedex 9-CHURENNES
Rennes, France
Not Yet Recruiting
32
FR-Rouen cedex-BECQUEREL
Rouen, France
Not Yet Recruiting
33
FR-Saint-Priest-en-Jarez-STETIENNE
Saint-Etienne, France
Not Yet Recruiting
34
FR-Le Chesnay cedex-CHVERSAILLES
Versailles, France
Not Yet Recruiting
35
DE-Berlin-CAMPUSBENFRANKLIN
Berlin, Germany
Not Yet Recruiting
36
DE-Berlin-CAMPUSVIRCHOW
Berlin, Germany
Not Yet Recruiting
37
DE-Berlin-VIVANTESNEUKOLLN
Berlin, Germany
Not Yet Recruiting
38
DE-Bochum-RUB
Bochum, Germany
Not Yet Recruiting
39
DE-Bonn-UNIBONN
Bonn, Germany
Not Yet Recruiting
40
DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
Braunschweig, Germany
Not Yet Recruiting
41
DE-Bremen-KBM
Bremen, Germany
Not Yet Recruiting
42
DE-Darmstadt-KLINIKUMDARMSTADT
Darmstadt, Germany
Not Yet Recruiting
43
DE-Flensburg-MALTESER
Flensburg, Germany
Not Yet Recruiting
44
DE-Freiburg-UNIKLINIKFREIBURG
Freiburg im Breisgau, Germany
Not Yet Recruiting
45
DE-Greifswald-UNIGREIFSWALD
Greifswald, Germany
Not Yet Recruiting
46
DE-Halle-UMH
Halle, Germany
Not Yet Recruiting
47
DE-Hamburg-ASKLEPIOSSTGEORG
Hamburg, Germany
Not Yet Recruiting
48
DE-Hamburg-UKE
Hamburg, Germany
Not Yet Recruiting
49
DE-Hannover-MHHANNOVER
Hanover, Germany
Not Yet Recruiting
50
DE-Hannover-SILOAHKRH
Hanover, Germany
Not Yet Recruiting
51
DE-Heilbronn-SLK
Heilbronn, Germany
Not Yet Recruiting
52
DE-Karlsruhe-KLINIKUMKARLSRUHE
Karlsruhe, Germany
Not Yet Recruiting
53
DE-Mainz-UNIMEDIZINMAINZ
Mainz, Germany
Not Yet Recruiting
54
DE-Minden-MUEHLENKREISKLINKEN
Minden, Germany
Not Yet Recruiting
55
DE-München-IRZTUM
München, Germany
Not Yet Recruiting
56
DE-Oldenburg-KLINIKUMOLDENBURG
Oldenburg, Germany
Not Yet Recruiting
57
DE-Regensburg-UKR
Regensburg, Germany
Not Yet Recruiting
58
DE-Stuttgart-KLINIKUMSTUTTGART
Stuttgart, Germany
Not Yet Recruiting
59
DE-Tübingen-MEDUNITUEBINGEN
Tübingen, Germany
Not Yet Recruiting
60
DE-Ulm-UNIKLINKULM
Ulm, Germany
Not Yet Recruiting
61
IE-Cork-CUH
Cork, Ireland
Not Yet Recruiting
62
IE-Dublin 7-MATER
Dublin, Ireland
Not Yet Recruiting
63
IE-Dublin 8-ST JAMES
Dublin, Ireland
Not Yet Recruiting
64
IE-Galway-UHGALWAY
Galway, Ireland
Not Yet Recruiting
65
IT-Bologna-MALPHIGI
Bologna, Italy
Not Yet Recruiting
66
IT-Milano-NIGUARDA
Milan, Italy
Not Yet Recruiting
67
IT-Roma-SAPIENZA
Roma, Italy
Not Yet Recruiting
68
IT-Roma-TORVERGATA
Roma, Italy
Not Yet Recruiting
69
IT-Torino-CITTADELLASALUTE
Torino, Italy
Not Yet Recruiting
70
LT-Vilnius-SANTA
Vilnius, Lithuania
Not Yet Recruiting
71
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
Not Yet Recruiting
72
NL-Amsterdam-VUMC
Amsterdam, Netherlands
Not Yet Recruiting
73
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
Not Yet Recruiting
74
NL-Breda-AMPHIA
Breda, Netherlands
Not Yet Recruiting
75
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Not Yet Recruiting
76
NL-Eindhoven-CATHARINA
Eindhoven, Netherlands
Not Yet Recruiting
77
NL-Enschede-MST
Enschede, Netherlands
Not Yet Recruiting
78
NL-Sittard-Geleen-ZUYDERLAND
Geleen, Netherlands
Not Yet Recruiting
79
NL-Groningen-UMCG
Groningen, Netherlands
Actively Recruiting
80
NL-Nijmegen-RADBOUDUMC
Nijmegen, Netherlands
Not Yet Recruiting
81
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
Not Yet Recruiting
82
NL-DenHaag-HAGA
The Hague, Netherlands
Not Yet Recruiting
83
NL-Utrecht-UMCU
Utrecht, Netherlands
Not Yet Recruiting
84
NL-Zwolle-ISALA
Zwolle, Netherlands
Not Yet Recruiting
85
NO-Bergen-HELSEBERGEN
Bergen, Norway
Not Yet Recruiting
86
NO-Oslo-OSLOUH
Oslo, Norway
Not Yet Recruiting
87
NO-Tromsø-NORTHNOORWEGEN
Tromsø, Norway
Not Yet Recruiting
88
NO-Trondheim-STOLAV
Trondheim, Norway
Not Yet Recruiting
89
ES-Barcelona-CLINICUB
Barcelona, Spain
Not Yet Recruiting
90
ES-Barcelona-GERMANTRIALS
Barcelona, Spain
Not Yet Recruiting
91
ES-Barcelona-SANTPAU
Barcelona, Spain
Not Yet Recruiting
92
ES-Girona-ICSTRUETA
Girona, Spain
Not Yet Recruiting
93
ES-Valencia-MALVARROSA
Valencia, Spain
Not Yet Recruiting
94
SE-Goteborg-SAHLGRENSKA
Gothenburg, Sweden
Not Yet Recruiting
95
SE-Lund-SUH
Lund, Sweden
Not Yet Recruiting
96
SE-Stockholm-KAROLINSKAHUDDINGE
Stockholm, Sweden
Not Yet Recruiting
97
SE-Uppsala-UPPSALAUH
Uppsala, Sweden
Not Yet Recruiting
98
CH-Basel-USB
Basel, Switzerland
Not Yet Recruiting
99
CH-Bellinzona-IOSI
Bellinzona, Switzerland
Not Yet Recruiting
100
CH-Bern-INSEL
Bern, Switzerland
Not Yet Recruiting
101
CH-Zurich-USZ
Zurich, Switzerland
Not Yet Recruiting
102
UK-Birmingham-QE
Birmingham, United Kingdom
Not Yet Recruiting
103
UK-Blackpool-BLACKPOOLVICTORIA
Blackpool, United Kingdom
Not Yet Recruiting
104
UK-Bristol-BRISTOLCENTRE
Bristol, United Kingdom
Not Yet Recruiting
105
UK-Cardiff-UHW
Cardiff, United Kingdom
Not Yet Recruiting
106
UK-Glasgow-BEATSON
Glasgow, United Kingdom
Not Yet Recruiting
107
UK-Leeds-STJAMESUH
Leeds, United Kingdom
Not Yet Recruiting
108
UK-Leicester-LEICESTERRI
Leicester, United Kingdom
Not Yet Recruiting
109
UK-London-KCH
London, United Kingdom
Not Yet Recruiting
110
UK-London-ROYALMARSDEN
London, United Kingdom
Not Yet Recruiting
111
UK-London-UNICOLLEGEHOSP
London, United Kingdom
Not Yet Recruiting
112
UK-Manchester-CHRISTIE
Manchester, United Kingdom
Not Yet Recruiting
113
UK-Manchester-ROYALINFIRMARY
Manchester, United Kingdom
Not Yet Recruiting
114
UK-Newcastle on Tyne-FREEMAN
Newcastle upon Tyne, United Kingdom
Not Yet Recruiting
115
UK-Nottingham-NOTTINGHAMCH
Nottingham, United Kingdom
Not Yet Recruiting
116
UK-Oxford-CHURCHILL
Oxford, United Kingdom
Not Yet Recruiting
117
UK-Portsmouth-QUEENALEXANDRA
Portsmouth, United Kingdom
Not Yet Recruiting
118
UK-Southampton-SOUTHAMPTONGH
Southampton, United Kingdom
Not Yet Recruiting
119
UK-Wolverhampton-NEWCROSSH
Wolverhampton, United Kingdom
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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