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Could a targeted pill boost chemo for tough blood cancer?

NCT ID NCT04628026

Disease control Sponsor: University of Ulm Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 11 times

Summary

This Phase 3 trial tests whether adding the drug venetoclax to standard chemotherapy helps adults with newly diagnosed acute myeloid leukemia (AML) or a related high-risk condition. About 650 participants aged 18 to 75 will receive either venetoclax or a placebo alongside chemo. The study measures how long people stay free of cancer events and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Venetoclax
What this could lead to
If successful, adding venetoclax to standard chemotherapy could improve remission rates and extend survival for people with newly diagnosed acute myeloid leukemia.
What could go wrong
This is a large Phase 3 trial, but venetoclax may cause serious side effects like low blood counts and infections. It is not a cure, and some patients may not benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 650 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Feb 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC). 2. Age ≥ 18 and ≤ 75 years. 3. Patients considered eligible for intensive chemotherapy. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 5. Molecular analysis centrally performed in AMLSG and HOVON laboratories. 6. 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). 7. 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. 8. 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. 9. 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. 10. 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. 11. 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. 12. Male patient must not donate sperm starting at screening and throughout the study period and for 27 weeks after the final study drug administration. 13. Able to understand and willing to sign an informed consent form (ICF).

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome with excess blasts-2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    89 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albert Schweitzer Ziekenhuis

    RECRUITING

    Dordrecht, Netherlands

  • Algemeen Ziekenhuis Delta

    RECRUITING

    Roeselare, Belgium

  • Amphia Hospital

    RECRUITING

    Breda, Netherlands

  • Amsterdam UMC Stichting

    RECRUITING

    Amsterdam, Netherlands

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, Germany

  • Asklepios Klinik St Georg

    RECRUITING

    Hamburg, Germany

  • Az St-Jan Brugge-Oostende A.V.

    NOT_YET_RECRUITING

    Bruges, Belgium

  • Barmherzige Brueder Trier gGmbH

    NOT_YET_RECRUITING

    Trier, Germany

  • CHU UCL NAMUR - Mont Godinne

    RECRUITING

    Yvoir, Belgium

  • Charité Berlin - Campus Benjamin Franklin

    RECRUITING

    Berlin, 12200, Germany

  • Charité Berlin - Campus Mitte

    RECRUITING

    Berlin, 10117, Germany

  • Charité Berlin - Campus Virchow Klinikum

    RECRUITING

    Berlin, Germany

  • Diakonie Klinikum Stuttgart

    RECRUITING

    Stuttgart, 70176, Germany

  • Erasmus MC - Daniel

    RECRUITING

    Rotterdam, Netherlands

  • Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH

    NOT_YET_RECRUITING

    Salzburg, Austria

  • Gesundheit Nord gGmbH Klinikverbund Bremen

    RECRUITING

    Bremen, Germany

  • HELIOS Klinikum Bad Saarow GmbH

    RECRUITING

    Bad Saarow, Germany

  • Hagaziekenhuis, locatie Leyweg

    RECRUITING

    The Hague, Netherlands

  • Hanusch Krankenhaus Der Wiener Gebietskrankenkasse

    RECRUITING

    Vienna, Austria

  • Haukeland University Hospital

    NOT_YET_RECRUITING

    Bergen, Norway

  • Helios Universitaetsklinikum Wuppertal

    RECRUITING

    Wuppertal, Germany

  • Helsinki University Central Hospital Meilahden Kolmiosairaala

    RECRUITING

    Helsinki, Finland

  • Isala Klinieken Stichting

    RECRUITING

    Zwolle, Netherlands

  • Jeroen Bosch ziekenhuis

    RECRUITING

    's-Hertogenbosch, Netherlands

  • Justus-Liebig-Universitaet Giessen

    RECRUITING

    Giessen, Germany

  • KRH Klinikum Siloah

    RECRUITING

    Hanover, Germany

  • Katholieke Universiteit te Leuven

    NOT_YET_RECRUITING

    Leuven, Belgium

  • Kepler Universitaetsklinikum GmbH

    NOT_YET_RECRUITING

    Linz, Austria

  • Klinikum Aschaffenburg-Alzenau gGmbH

    RECRUITING

    Aschaffenburg, Germany

  • Klinikum Darmstadt GmbH

    NOT_YET_RECRUITING

    Darmstadt, Germany

  • Klinikum Frankfurt Hoechst GmbH

    RECRUITING

    Frankfurt, Germany

  • Klinikum Hochsauerland GmbH

    RECRUITING

    Meschede, Germany

  • Klinikum Mutterhaus der Borromaerinnen

    RECRUITING

    Trier, Germany

  • Klinikum Oldenburg AöR

    RECRUITING

    Oldenburg, Germany

  • Klinikum Traunstein

    RECRUITING

    Traunstein, Germany

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    RECRUITING

    Ludwigshafen, Germany

  • Klinikum rechts der Isar der TU Muenchen AöR

    RECRUITING

    München, Germany

  • Knappschaftskrankenhaus Bochum-Langendreer

    RECRUITING

    Bochum, 44892, Germany

  • Landeskrankenhaus (LKH) Rankweil, Interne E am Landeskrankenhaus Rankweil

    RECRUITING

    Rankweil, Austria

  • Leids Universitair Medisch Centrum (LUMC)

    RECRUITING

    Leiden, Netherlands

  • Maastricht University Medical Center+ (MUMC+)

    NOT_YET_RECRUITING

    Maastricht, Netherlands

  • Marien Hospital Duesseldorf GmbH

    WITHDRAWN

    Düsseldorf, Germany

  • Marien Hospital Herne

    RECRUITING

    Herne, Germany

  • Maxima Medisch Centrum

    RECRUITING

    Eindhoven, Netherlands

  • Meander Medisch Centrum

    RECRUITING

    Amersfoort, Netherlands

  • Medisch Centrum Leeuwarden B.V.

    RECRUITING

    Leeuwarden, Netherlands

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, Netherlands

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Muhlenkreiskliniken AöR

    RECRUITING

    Minden, Germany

  • North Estonia Medical Centre Foundation

    RECRUITING

    Tallinn, Estonia

  • OLVG

    RECRUITING

    Amsterdam, Netherlands

  • Ordensklinikum Linz GmbH

    RECRUITING

    Linz, Austria

  • Ortenauklinikum

    RECRUITING

    Offenburg, Germany

  • Otto Von Guericke Universitaet Magdeburg

    RECRUITING

    Magdeburg, Germany

  • Radboudumc

    RECRUITING

    Nijmegen, Netherlands

  • Reinier de Graaf Gasthuis

    RECRUITING

    Delft, Netherlands

  • Rijnstate Ziekenhuis Stichting

    RECRUITING

    Arnhem, Netherlands

  • SLK-Kliniken Heilbronn GmbH

    RECRUITING

    Heilbronn, Germany

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    RECRUITING

    Villingen-Schwenningen, Germany

  • Sint Antonius Ziekenhuis Stichting

    RECRUITING

    Nieuwegein, Netherlands

  • St. Johannes Hospital Dortmund

    RECRUITING

    Dortmund, Germany

  • St. Olavs Hospital

    RECRUITING

    Trondheim, Norway

  • Staedtisches Klinikum Braunschweig

    RECRUITING

    Braunschweig, 38114, Germany

  • Staedtisches Klinikum Karlsruhe gGmbH

    NOT_YET_RECRUITING

    Karlsruhe, Germany

  • Stavanger Univ. Hosp.-Rogaland Hosp.

    NOT_YET_RECRUITING

    Oslo, Norway

  • Städtisches Klinikum Karlsruhe

    RECRUITING

    Karlsruhe, 76133, Germany

  • Tampere University Hospital

    NOT_YET_RECRUITING

    Tampere, Finland

  • Tartu University Hospital

    RECRUITING

    Tartu, Estonia

  • Tirol Kliniken GmbH

    NOT_YET_RECRUITING

    Innsbruck, Austria

  • UMCG

    RECRUITING

    Groningen, Netherlands

  • UMCU

    RECRUITING

    Utrecht, Netherlands

  • UNIVERSITÄTSKLINIKUM Schleswig-Holstein

    RECRUITING

    Lübeck, Germany

  • Uniklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Uniklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Univeritätsklinikum

    RECRUITING

    Halle, Germany

  • Universitaetsklinikum

    RECRUITING

    Rostock, Germany

  • Universitaetsklinikum Regensburg AöR

    NOT_YET_RECRUITING

    Regensburg, Germany

  • Universitaetsklinikum des Saarlandes AöR

    RECRUITING

    Homburg, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    RECRUITING

    Mainz, Germany

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Brussels, Belgium

  • University Hospital Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University Hospital of North Norway

    NOT_YET_RECRUITING

    Tromsø, Norway

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsmedizin Greifswald

    RECRUITING

    Greifswald, Germany

  • Vilnius University Hospital Santaros Klinik

    NOT_YET_RECRUITING

    Vilnius, Lithuania

  • Vivantes Neukölln

    NOT_YET_RECRUITING

    Berlin, Germany

  • Vivantes Spandau

    WITHDRAWN

    Berlin, Germany

  • Vivantes am Urban

    NOT_YET_RECRUITING

    Berlin, Germany

  • Wespfalz-Klinikum

    RECRUITING

    Kaiserslautern, Germany

  • Wilhelm-Anton-Hospital Goch

    RECRUITING

    Goch, Germany

  • Ziekenhuis Aan De Stroom

    NOT_YET_RECRUITING

    Antwerp, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.