Actively Recruiting
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
Led by University of Ulm · Updated on 2026-05-14
650
Participants Needed
91
Research Sites
489 weeks
Total Duration
On this page
Sponsors
U
University of Ulm
Lead Sponsor
S
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2
CONDITIONS
Official Title
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute myeloid leukemia (AML) according to International Consensus Classification
- Age 18 to 75 years
- Eligible for intensive chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Molecular analysis performed centrally in AMLSG and HOVON labs
- Adequate kidney function (serum creatinine ≤ 2.0 × upper limit of normal or creatinine clearance > 40 mL/min)
- Adequate liver function (bilirubin ≤ 2.5 × upper limit unless Gilbert's disease or leukemic involvement approved; AST, ALT, ALP ≤ 3.0 × upper limit unless leukemic involvement approved)
- No prior chemotherapy for AML except hydroxyurea for up to 14 days during screening
- Prior erythroid stimulating agents or hypomethylating agents stopped at least 4 weeks before study
- No use of strong or moderate CYP3A inducers 7 days before study start and no chronic use of these
- Female patients either nonchildbearing or agree to strict birth control and pregnancy testing requirements
- Male patients agree to use condom with women of childbearing potential and not donate sperm during study and for 27 weeks after
- Ability to understand and sign informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 91 locations
1
Tirol Kliniken GmbH
Innsbruck, Austria
Not Yet Recruiting
2
Kepler Universitaetsklinikum GmbH
Linz, Austria
Not Yet Recruiting
3
Ordensklinikum Linz GmbH
Linz, Austria
Not Yet Recruiting
4
Landeskrankenhaus (LKH) Rankweil, Interne E am Landeskrankenhaus Rankweil
Rankweil, Austria
Not Yet Recruiting
5
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Salzburg, Austria
Not Yet Recruiting
6
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Vienna, Austria
Not Yet Recruiting
7
Ziekenhuis Aan De Stroom
Antwerp, Belgium
Not Yet Recruiting
8
Az St-Jan Brugge-Oostende A.V.
Bruges, Belgium
Not Yet Recruiting
9
Universitair Ziekenhuis Brussel
Brussels, Belgium
Actively Recruiting
10
Katholieke Universiteit te Leuven
Leuven, Belgium
Not Yet Recruiting
11
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Actively Recruiting
12
CHU UCL NAMUR - Mont Godinne
Yvoir, Belgium
Actively Recruiting
13
North Estonia Medical Centre Foundation
Tallinn, Estonia
Not Yet Recruiting
14
Tartu University Hospital
Tartu, Estonia
Actively Recruiting
15
Helsinki University Central Hospital Meilahden Kolmiosairaala
Helsinki, Finland
Not Yet Recruiting
16
Tampere University Hospital
Tampere, Finland
Not Yet Recruiting
17
Klinikum Aschaffenburg-Alzenau gGmbH
Aschaffenburg, Germany
Actively Recruiting
18
HELIOS Klinikum Bad Saarow GmbH
Bad Saarow, Germany
Actively Recruiting
19
Charité Berlin - Campus Mitte
Berlin, Germany, 10117
Actively Recruiting
20
Charité Berlin - Campus Benjamin Franklin
Berlin, Germany, 12200
Actively Recruiting
21
Charité Berlin - Campus Virchow Klinikum
Berlin, Germany
Actively Recruiting
22
Vivantes am Urban
Berlin, Germany
Not Yet Recruiting
23
Vivantes Neukölln
Berlin, Germany
Not Yet Recruiting
24
Vivantes Spandau
Berlin, Germany
Withdrawn
25
Knappschaftskrankenhaus Bochum-Langendreer
Bochum, Germany, 44892
Actively Recruiting
26
Uniklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
27
Staedtisches Klinikum Braunschweig
Braunschweig, Germany, 38114
Actively Recruiting
28
Gesundheit Nord gGmbH Klinikverbund Bremen
Bremen, Germany
Actively Recruiting
29
Klinikum Darmstadt GmbH
Darmstadt, Germany
Not Yet Recruiting
30
St. Johannes Hospital Dortmund
Dortmund, Germany
Actively Recruiting
31
Marien Hospital Duesseldorf GmbH
Düsseldorf, Germany
Withdrawn
32
Klinikum Frankfurt Hoechst GmbH
Frankfurt, Germany
Actively Recruiting
33
Justus-Liebig-Universitaet Giessen
Giessen, Germany
Actively Recruiting
34
Wilhelm-Anton-Hospital Goch
Goch, Germany
Actively Recruiting
35
Universitätsmedizin Greifswald
Greifswald, Germany
Actively Recruiting
36
Univeritätsklinikum
Halle, Germany
Actively Recruiting
37
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
38
Asklepios Klinik Altona
Hamburg, Germany
Actively Recruiting
39
Asklepios Klinik St Georg
Hamburg, Germany
Actively Recruiting
40
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
41
KRH Klinikum Siloah
Hanover, Germany
Actively Recruiting
42
SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
Actively Recruiting
43
Marien Hospital Herne
Herne, Germany
Actively Recruiting
44
Universitaetsklinikum des Saarlandes AöR
Homburg, Germany
Actively Recruiting
45
Wespfalz-Klinikum
Kaiserslautern, Germany
Not Yet Recruiting
46
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Actively Recruiting
47
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
Not Yet Recruiting
48
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, Germany
Actively Recruiting
49
UNIVERSITÄTSKLINIKUM Schleswig-Holstein
Lübeck, Germany
Actively Recruiting
50
Otto Von Guericke Universitaet Magdeburg
Magdeburg, Germany
Actively Recruiting
51
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany
Actively Recruiting
52
Klinikum Hochsauerland GmbH
Meschede, Germany
Actively Recruiting
53
Muhlenkreiskliniken AöR
Minden, Germany
Actively Recruiting
54
Klinikum rechts der Isar der TU Muenchen AöR
München, Germany
Not Yet Recruiting
55
Ortenauklinikum
Offenburg, Germany
Not Yet Recruiting
56
Klinikum Oldenburg AöR
Oldenburg, Germany
Actively Recruiting
57
Universitaetsklinikum Regensburg AöR
Regensburg, Germany
Not Yet Recruiting
58
Universitaetsklinikum
Rostock, Germany
Actively Recruiting
59
Diakonie Klinikum Stuttgart
Stuttgart, Germany, 70176
Actively Recruiting
60
Klinikum Traunstein
Traunstein, Germany
Actively Recruiting
61
Barmherzige Brueder Trier gGmbH
Trier, Germany
Not Yet Recruiting
62
Klinikum Mutterhaus der Borromaerinnen
Trier, Germany
Actively Recruiting
63
Uniklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
64
University Hospital Ulm
Ulm, Germany, 89081
Actively Recruiting
65
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany
Actively Recruiting
66
Helios Universitaetsklinikum Wuppertal
Wuppertal, Germany
Actively Recruiting
67
Vilnius University Hospital Santaros Klinik
Vilnius, Lithuania
Not Yet Recruiting
68
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Actively Recruiting
69
Meander Medisch Centrum
Amersfoort, Netherlands
Actively Recruiting
70
Amsterdam UMC Stichting
Amsterdam, Netherlands
Actively Recruiting
71
OLVG
Amsterdam, Netherlands
Actively Recruiting
72
Rijnstate Ziekenhuis Stichting
Arnhem, Netherlands
Actively Recruiting
73
Amphia Hospital
Breda, Netherlands
Actively Recruiting
74
Reinier de Graaf Gasthuis
Delft, Netherlands
Actively Recruiting
75
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Actively Recruiting
76
Maxima Medisch Centrum
Eindhoven, Netherlands
Actively Recruiting
77
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
78
UMCG
Groningen, Netherlands
Actively Recruiting
79
Medisch Centrum Leeuwarden B.V.
Leeuwarden, Netherlands
Actively Recruiting
80
Leids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands
Actively Recruiting
81
Maastricht University Medical Center+ (MUMC+)
Maastricht, Netherlands
Not Yet Recruiting
82
Sint Antonius Ziekenhuis Stichting
Nieuwegein, Netherlands
Actively Recruiting
83
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
84
Erasmus MC - Daniel
Rotterdam, Netherlands
Actively Recruiting
85
Hagaziekenhuis, locatie Leyweg
The Hague, Netherlands
Actively Recruiting
86
UMCU
Utrecht, Netherlands
Actively Recruiting
87
Isala Klinieken Stichting
Zwolle, Netherlands
Not Yet Recruiting
88
Haukeland University Hospital
Bergen, Norway
Not Yet Recruiting
89
Stavanger Univ. Hosp.-Rogaland Hosp.
Oslo, Norway
Not Yet Recruiting
90
University Hospital of North Norway
Tromsø, Norway
Not Yet Recruiting
91
St. Olavs Hospital
Trondheim, Norway
Actively Recruiting
Research Team
H
Hartmut Doehner, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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