NCT04628026RecruitingPhase 3
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 650 (estimated)
- First submitted
- 3 Nov 2020
- Start date
- 13 Sept 2022
- Primary completion date
- Mar 2029
- Lead sponsor
- University of Ulm
- NCT number
- NCT04628026
- EU CT number
- 2023-507518-28-00
- EudraCT number
- 2020-004453-71
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 650
- From 13 Sept 2022 to the primary completion date, Mar 2029
- 87 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC).
- Age ≥ 18 and ≤ 75 years.
- Patients considered eligible for intensive chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Molecular analysis centrally performed in AMLSG and HOVON laboratories.
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \>40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR).
- Adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 2.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Principal Investigators or Trial Coordinators of the study
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Principal Investigators or Trial Coordinators.
- No prior chemotherapy for AML, except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \[WBC\] counts \> 25x109/L); patients may have had previous treatment with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of MDS; ESA and HMAs have to be stopped at least four weeks before start of study treatment.
- Patients must not have received a known strong or moderate CYP3A inducer 7 days before start of study treatment. Patients must have no known medical conditions requiring chronic therapy with moderate or strong CYP3A inducers.
- Female patient must either:
- Be of nonchildbearing potential:
- Postmenopausal (defined as at least 1 year without any menses)
- Documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening)
- Or, if of childbearing potential (not surgically sterile and not postmenopausal)
- Not planning to become pregnant during the study and for 6 months after the final study drug administration
- And have a negative urine or serum pregnancy test at screening
- And, if heterosexually active, agree to consistently apply one highly effective\* method of birth control in combination to a barrier method for the duration of the study and for 27 weeks after the final study drug administration
- \*Highly effective forms of birth control include
- Consistent and correct usage of established hormonal contraceptives that inhibit ovulation for at least 1 month prior to taking study drug. (hormonal contraception is only a highly effective method of birth control, if a combined \[estrogen and progestogen containing\] hormonal contraception or a progestogen-only hormonal contraception - both associated with inhibition of ovulation - is used.
- Established intrauterine device (IUD) or intrauterine system (IUS)
- Bilateral tubal occlusion
- Vasectomy - a vasectomy is highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.
- Male is sterile due to a bilateral orchiectomy.
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
- \*List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period.
- Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.
- Female patient must not donate ova starting at screening and throughout the study period, and for 27 weeks after the final study drug administration.
- Men must use a latex condom during any sexual contact with WOCBP, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 27 weeks after the final study drug administration). In addition, their female partners of childbearing potential have to use a highly effective method of birth control.
- Male patient must not donate sperm starting at screening and throughout the study period and for 27 weeks after the final study drug administration.
- Able to understand and willing to sign an informed consent form (ICF).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (87)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tirol Kliniken GmbH Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Landeskrankenhaus (LKH) Rankweil, Interne E am Landeskrankenhaus Rankweil Coordinator of this site? Confirm its status | Rankweil | Austria | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| Universitair Ziekenhuis Brussel Coordinator of this site? Confirm its status | Brussel | Belgium | Recruiting |
| Katholieke Universiteit te Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| CHU UCL NAMUR - Mont Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Klinikum Hochsauerland GmbH Coordinator of this site? Confirm its status | Arnsberg | Germany | Recruiting |
| Klinikum Aschaffenburg-Alzenau gGmbH Coordinator of this site? Confirm its status | Aschaffenburg | Germany | Recruiting |
| HELIOS Klinikum Bad Saarow GmbH Coordinator of this site? Confirm its status | Bad Saarow | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Gesundheit Nord gGmbH Klinikverbund Bremen Coordinator of this site? Confirm its status | Bremen | Germany | Recruiting |
| Staedtisches Klinikum Braunschweig gGmbH Coordinator of this site? Confirm its status | Brunswick | Germany | Recruiting |
| Klinikum Darmstadt GmbH Coordinator of this site? Confirm its status | Darmstadt | Germany | Recruiting |
| St.-Johannes-Hospital Dortmund Coordinator of this site? Confirm its status | Dortmund | Germany | Recruiting |
| Klinikum Frankfurt Hoechst GmbH Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Wilhelm-Anton-Hospital Goch Coordinator of this site? Confirm its status | Goch | Germany | Recruiting |
| Universitätsmedizin Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg Coordinator of this site? Confirm its status | Halle (Saale) | Germany | Recruiting |
| Asklepios Klinik Altona Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Asklepios Klinik St George Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Johanniter-Kliniken Hamm GmbH Coordinator of this site? Confirm its status | Hamm | Germany | Recruiting |
| KRH Klinikum SILOAH Coordinator of this site? Confirm its status | Hannover | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Heilbronn | Germany | Recruiting |
| Marien Hospital Herne Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Universitaetsklinikum des Saarlandes AöR Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
| Westpfalz-Klinikum GmbH Coordinator of this site? Confirm its status | Kaiserslautern | Germany | Recruiting |
| Staedtisches Klinikum Karlsruhe gGmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Recruiting |
| Universitätsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH Coordinator of this site? Confirm its status | Ludwigshafen Am Rhein | Germany | Recruiting |
| Otto Von Guericke Universitaet Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Muhlenkreiskliniken AöR Coordinator of this site? Confirm its status | Minden | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Ortenau Klinikum Coordinator of this site? Confirm its status | Offenburg | Germany | Recruiting |
| Klinikum Oldenburg Aor Coordinator of this site? Confirm its status | Oldenburg | Germany | Recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus Und Paulinenhilfe gGmbH Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| Kliniken Suedostbayern AG Coordinator of this site? Confirm its status | Traunstein | Germany | Recruiting |
| Klinikum Mutterhaus der Borromaeerinnen gGmbH Coordinator of this site? Confirm its status | Trier | Germany | Recruiting |
| Barmherzige Brueder Trier gGmbH Coordinator of this site? Confirm its status | Trier | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Coordinator of this site? Confirm its status | Villingen-Schwenningen | Germany | Recruiting |
| Helios Universitaetsklinikum Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Recruiting |
| North Estonia Medical Centre Foundation Coordinator of this site? Confirm its status | Tallinn | Estonia | Recruiting |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu Linn | Estonia | Recruiting |
| Helsinki University Central Hospital Meilahden Kolmiosairaala Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Vilnius University Hospital Santaros Klinik Coordinator of this site? Confirm its status | Vilnius | Lithuania | Not yet recruiting |
| Meander Medisch Centrum Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Reinier de Graaf Gasthuis Coordinator of this site? Confirm its status | Delft | Netherlands | Recruiting |
| Jeroen Bosch ziekenhuis Coordinator of this site? Confirm its status | Den Bosch | Netherlands | Recruiting |
| Hagaziekenhuis, locatie Leyweg Coordinator of this site? Confirm its status | Den Haag | Netherlands | Recruiting |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Recruiting |
| Máxima Medisch Centrum Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Medisch Centrum Leeuwarden B.V. Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Maastricht University Medical Center+ (MUMC+) Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Stichting Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Erasmus MC - Daniel Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| UMCU Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Stavanger Univ. Hosp.-Rogaland Hosp. Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| University Hospital of North Norway Coordinator of this site? Confirm its status | Tromso | Norway | Recruiting |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.