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AzTrials

Acute Myeloid LeukemiaPhase 3NCT04628026

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

A Phase 3 study testing Venetoclax, Standard chemotherapy and Allogeneic stem cell transplantation in people with Acute Myeloid Leukemia, run by University of Ulm at 91 sites in 8 countries.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Venetoclax, Standard chemotherapy and Allogeneic stem cell transplantation
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
91 sitesin 8 countries
Study dates
13 Sep 2022to Feb 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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).

Who cannot join

None listed.

Trial locations and contacts

91 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Hartmut Doehner, MD contact

004973150045501

harmut.doehner@uniklinik-ulm.de

91 sites in 8 countries

Germany50 sites, 48 recruiting

  • Klinikum Aschaffenburg-Alzenau gGmbH

    Aschaffenburg

    Manfred Welslau

    Recruiting

  • HELIOS Klinikum Bad Saarow GmbH

    Bad Saarow

    Daniel Schoendube

    Recruiting

  • Charité Berlin - Campus Mitte

    Berlin, 10117

    Marie-Luise Huetter-Kroenke, Prof.

    Recruiting

  • Charité Berlin - Campus Benjamin Franklin

    Berlin, 12200

    Marie-Luise Hütter-Kroenke

    Recruiting

  • Charité Berlin - Campus Virchow Klinikum

    Berlin

    Marie-Luise Huetter-Kroenke, Prof.

    Recruiting

  • Vivantes am Urban

    Berlin

    Hannes Kroenlein

    Not yet recruiting

  • Vivantes Neukölln

    Berlin

    Maike de Wit

    Not yet recruiting

  • Vivantes Spandau

    Berlin

    Withdrawn

  • Knappschaftskrankenhaus Bochum-Langendreer

    Bochum, 44892

    Roland Schroers, Prof.

    Recruiting

  • Uniklinikum Bonn

    Bonn, 53127

    Lino Teichmann, Dr.

    Recruiting

  • Staedtisches Klinikum Braunschweig

    Braunschweig, 38114

    Jürgen Krauter, Prof.

    Recruiting

  • Gesundheit Nord gGmbH Klinikverbund Bremen

    Bremen

    Maher Hanoun

    Recruiting

  • Klinikum Darmstadt GmbH

    Darmstadt

    Helga Bernhard

    Not yet recruiting

  • St. Johannes Hospital Dortmund

    Dortmund

    Eva Schulte

    Recruiting

  • Marien Hospital Duesseldorf GmbH

    Düsseldorf

    Withdrawn

  • Klinikum Frankfurt Hoechst GmbH

    Frankfurt

    Felicitas Scholten

    Recruiting

  • Justus-Liebig-Universitaet Giessen

    Giessen

    Tobias Arnold

    Recruiting

  • Wilhelm-Anton-Hospital Goch

    Goch

    Volker Runde

    Recruiting

  • Universitätsmedizin Greifswald

    Greifswald

    Jan Kroenke

    Recruiting

  • Univeritätsklinikum

    Halle

    Michael Heuser

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Franziska Westendorf

    Recruiting

  • Asklepios Klinik Altona

    Hamburg

    Hans Salwender

    Recruiting

  • Asklepios Klinik St Georg

    Hamburg

    Ahmet Elmaagacli

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Daniela Vanessa Wenge, Dr.

    Recruiting

  • KRH Klinikum Siloah

    Hanover

    Kim Marienhagen

    Recruiting

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn

    Markus Lindauer

    Recruiting

  • Marien Hospital Herne

    Herne

    Dirk Strumberg

    Recruiting

  • Universitaetsklinikum des Saarlandes AöR

    Homburg

    Thomas Bittenbring

    Recruiting

  • Wespfalz-Klinikum

    Kaiserslautern

    Gerhard Held

    Recruiting

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

    Mark Ringhoffer, Prof.

    Recruiting

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe

    Mark, Ringhoffer

    Not yet recruiting

  • UNIVERSITÄTSKLINIKUM Schleswig-Holstein

    Lübeck

    Friederike Wortmann

    Recruiting

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen

    Peter Paschka

    Recruiting

  • Otto Von Guericke Universitaet Magdeburg

    Magdeburg

    Mirjeta Berisha

    Recruiting

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    Mainz

    Michael Kuehn

    Recruiting

  • Klinikum Hochsauerland GmbH

    Meschede

    Mohammad Wattad

    Recruiting

  • Muhlenkreiskliniken AöR

    Minden

    Kai Wille

    Recruiting

  • Klinikum rechts der Isar der TU Muenchen AöR

    München

    Katharina Götze

    Recruiting

  • Ortenauklinikum

    Offenburg

    Carsten Schwaenen

    Recruiting

  • Klinikum Oldenburg AöR

    Oldenburg

    Andreas Voss

    Recruiting

  • Universitaetsklinikum Regensburg AöR

    Regensburg

    Hendrik Poeck

    Recruiting

  • Universitaetsklinikum

    Rostock

    Frauke Theis

    Recruiting

  • Diakonie Klinikum Stuttgart

    Stuttgart, 70176

    Jochen Greiner, Prof

    Recruiting

  • Klinikum Traunstein

    Traunstein

    Florian Zettl

    Recruiting

  • Barmherzige Brueder Trier gGmbH

    Trier

    Iordanis Deligiannis

    Recruiting

  • Klinikum Mutterhaus der Borromaerinnen

    Trier

    Frank Ruecker

    Recruiting

  • Uniklinikum Tübingen

    Tübingen, 72076

    Claudia Lengerke, Prof. Dr.

    Recruiting

  • University Hospital Ulm

    Ulm, 89081

    Hartmut Döhner, Prof. Dr.

    Gaidzik Verena, PD Dr.

    Recruiting

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen

    Paul La Rosee

    Recruiting

  • Helios Universitaetsklinikum Wuppertal

    Wuppertal

    Silke Schostok

    Recruiting

Other trials in Germany

Netherlands20 sites, 20 recruiting

  • Jeroen Bosch ziekenhuis

    's-Hertogenbosch

    A. Herbers

    Recruiting

  • Meander Medisch Centrum

    Amersfoort

    M. Corsten

    Recruiting

  • Amsterdam UMC Stichting

    Amsterdam

    D. de Leeuw

    Recruiting

  • OLVG

    Amsterdam

    A. Gerrits

    Recruiting

  • Rijnstate Ziekenhuis Stichting

    Arnhem

    M. Cuijpers

    Recruiting

  • Amphia Hospital

    Breda

    R. Fiets

    Recruiting

  • Reinier de Graaf Gasthuis

    Delft

    R. Brouwer

    Recruiting

  • Albert Schweitzer Ziekenhuis

    Dordrecht

    P. Westerweel

    Recruiting

  • Maxima Medisch Centrum

    Eindhoven

    L. Tick

    Recruiting

  • Medisch Spectrum Twente

    Enschede

    T. Snijders

    Recruiting

  • UMCG

    Groningen

    S. K. Klein

    Recruiting

  • Medisch Centrum Leeuwarden B.V.

    Leeuwarden

    B. Franken

    Recruiting

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden

    H. Veelken

    Recruiting

  • Maastricht University Medical Center+ (MUMC+)

    Maastricht

    J. van Elssen

    Recruiting

  • Sint Antonius Ziekenhuis Stichting

    Nieuwegein

    M. Söhne

    Recruiting

  • Radboudumc

    Nijmegen

    J. Janssen

    Recruiting

  • Erasmus MC - Daniel

    Rotterdam

    M. Jongen-Lavrenic

    Recruiting

  • Hagaziekenhuis, locatie Leyweg

    The Hague

    D. Lammeren, van-Venema

    Recruiting

  • UMCU

    Utrecht

    A. van Rhenen

    Recruiting

  • Isala Klinieken Stichting

    Zwolle

    G. van Sluis

    Recruiting

Other trials in Netherlands

Austria6 sites, 6 recruiting

  • Tirol Kliniken GmbH

    Innsbruck

    David Nachbaur

    Not yet recruiting

  • Kepler Universitaetsklinikum GmbH

    Linz

    Clemens Schmitt

    Not yet recruiting

  • Ordensklinikum Linz GmbH

    Linz

    Sigrid Machherndl-Spandl

    Recruiting

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

    Rankweil

    Bernd Hartmann

    Recruiting

  • Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH

    Salzburg

    Lisa Pleyer

    Not yet recruiting

  • Hanusch Krankenhaus Der Wiener Gebietskrankenkasse

    Vienna

    Michael Pfeilstöcker, Prof.

    Recruiting

Other trials in Austria

Belgium6 sites, 6 recruiting

  • Ziekenhuis Aan De Stroom

    Antwerp

    D. Breems

    Not yet recruiting

  • Az St-Jan Brugge-Oostende A.V.

    Bruges

    T. Lodewyck

    Recruiting

  • Universitair Ziekenhuis Brussel

    Brussels

    A. de Becker

    Recruiting

  • Katholieke Universiteit te Leuven

    Leuven

    J. Maertens

    Not yet recruiting

  • Algemeen Ziekenhuis Delta

    Roeselare

    D. Deeren

    Recruiting

  • CHU UCL NAMUR - Mont Godinne

    Yvoir

    E. Collinge

    Recruiting

Other trials in Belgium

Norway4 sites, 4 recruiting

  • Haukeland University Hospital

    Bergen

    O. Sefland

    Recruiting

  • Stavanger Univ. Hosp.-Rogaland Hosp.

    Oslo

    A. Lenartova

    Not yet recruiting

  • University Hospital of North Norway

    Tromsø

    N. Leknes

    Not yet recruiting

  • St. Olavs Hospital

    Trondheim

    A. von Krogh

    Recruiting

Other trials in Norway

Estonia2 sites, 2 recruiting

  • North Estonia Medical Centre Foundation

    Tallinn

    K. Palk

    Recruiting

  • Tartu University Hospital

    Tartu

    A. Kaare

    Recruiting

Other trials in Estonia

Finland2 sites, 2 recruiting

  • Helsinki University Central Hospital Meilahden Kolmiosairaala

    Helsinki

    M. Kontro

    Recruiting

  • Tampere University Hospital

    Tampere

    J. Rimpilainen

    Not yet recruiting

Other trials in Finland

Lithuania1 site, 1 recruiting

  • Vilnius University Hospital Santaros Klinik

    Vilnius

    A. Zucenka

    Not yet recruiting

Other trials in Lithuania

About this study

Official title: 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

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

Read the detailed description

Prospective, multicenter, double-blind, randomized, placebo-controlled phase 3 clinical study. The randomized phase of the study will be preceded by a feasibility run-in dose-escalation phase in patients with AML in which the venetoclax dose for the phase 3 part will be established.

After the feasibility run-in phase, eligible patients will be randomized to intensive chemotherapy with venetoclax or placebo. Patients will receive two cycles of induction chemotherapy; patients achieving CR or CRi after two cycles will continue with consolidation treatment according to initial randomization, and according to Cooperative Group-specific consolidation regimens or investigator choice. Patients achieving morphologic leukemia-free state (MLFS) only, may also continue consolidation treatment on protocol. Assignment to either allogeneic hematopoietic cell transplantation (HCT), conventional chemotherapy or autologous HCT will be done according to institutional standards, and based on (prognostic) disease characteristics, individual patient assessment, and established comorbidity risk scores (e.g., HCT-CI score).

Being tested
Venetoclax, Placebo, Standard chemotherapy, Allogeneic stem cell transplantation
Keywords
adult patients
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Venetoclax will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy

  • PlaceboDrug

    Placebo will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy

  • Standard chemotherapyCombination product

    Induction cycle 1: Patients will receive cytarabine 200 mg/m2 continuous IV (days 1-7) and daunorubicin 60 mg/m2 IV (days 1-3). Induction cycle 2: Patients ≤ 60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4, and daunorubicin 60 mg/m2 IV (days 1-3). Patients >60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4 without daunorubicin.

    Consolidation chemotherapy with intermediate doses of cytarabine. Patients ≤60 yrs will receive up to 3 cycles of IDAC (single dose 1500 mg/m2 every 12 hours, days 1-3). Patients who are >60 yrs will receive up to 3 cycles of IDAC with single doses of 1000 mg/m2, every 12 hours, days 1-3. In patients >60 yrs less than 3 cycles of IDAC or dose-reduced IDAC (500 mg/m2 per single dose) may be given based on an individual risk assessment.

  • Allogeneic stem cell transplantationOther

    Generally, patients will proceed to allogeneic HCT upon completion of remission induction chemotherapy. It is however allowed, as per investigator's discretion, for a patient to receive 'bridging' consolidation chemotherapy in exceptional cases of delay towards transplantation. At baseline, HLA-compatible donor search must be initiated as soon as possible, first among siblings and second in the world donor bank for unrelated donors or cord blood. In order to avoid inappropriate delay in cases where no suitable sibling is present, high-resolution HLA typing should be performed immediately after registration, enabling a more rapid matched-unrelated donor search. In case no sibling or unrelated donor can be identified, haploidentical allogeneic HCT is allowed. Conditioning and GVHD prophylaxis will take place according to institutional guidelines. Patients who undergo allogeneic HCT will not receive venetoclax during conditioning, engraftment or after hematologic recovery.

Study groups in NCT04628026
Study groupRoleWhat they receive
1Experimentalstandard chemotherapy in combination with venetoclax
Receives: Drug: Venetoclax; Combination Product: Standard chemotherapy; Other: Allogeneic stem cell transplantation
2Placebo comparatorstandard chemotherapy in combination with placebo
Receives: Drug: Placebo; Combination Product: Standard chemotherapy; Other: Allogeneic stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival (EFS)

    EFS in adult patients with newly diagnosed AML, defined as the time from randomization to treatment failure, death from any cause, or relapse after achieving CR or CRi, or start of new therapy due to confirmed molecular relapse whichever occurs first. Treatment failure is defined as not attaining CR or CRi after induction chemotherapy, and EFS event time for treatment failure is Day 1 of post-randomization

    Measured: 6 months/16 months after inclusion of last patient

  2. Frequency of dose-limiting toxicities (DLTs) during the observation period (Primary safety endpoint during dose-finding phase)

    Frequency of dose-limiting toxicities (DLTs) during the observation period (from start of cycle 1 up to a maximum of day 42, or until the start of cycle 2)

    Measured: after cycle 1 (maximal day 42)

Secondary outcomes (14)

  1. Overall Survival (OS)

    OS in patients with newly diagnosed AML

    Measured: 6 months/16 months/28 months after inclusion of last patient

  2. CR/CRi rate

    Complete remission (CR/CRi) rate in newly diagnosed AML patients defined as the proportion of AML patients with CR/CRi after induction chemotherapy

    Measured: 2 months

  3. CR rate

    Complete remission (CR) rates in newly diagnosed AML patients defined as the proportion of AML patients with CR after induction chemotherapy

    Measured: 2 months

  4. Event Free Survival (EFS) including CRh

    EFS in adult patients with newly diagnosed AML, defined as the time from randomization to treatment failure, death from any cause, or relapse after achieving CR, CRh or CRi, or start of new therapy due to confirmed molecular relapse whichever occurs first. Treatment failure is defined as not attaining CR, CRh or CRi by end of induction chemotherapy, i.e. if a patient's best response during or at completion of the induction treatment is less than CR/CRh/CRi

    Measured: 6 months/16 months after inclusion of last patient

  5. Rates of complete remission without measurable residual disease (CRMRD-) after induction therapy

    Rates of complete remission without measurable residual disease (CRMRD-) after induction therapy, defined as the proportion of AML patients achieving CR with negativity for a genetic marker by RT-qPCR, and/or with negativity by multi-color flow cytometry, if studied pre-treatment

    Measured: 2 months

  6. Relapse-free survival (RFS) in newly diagnosed AML patients

    Relapse-free survival (RFS) in newly diagnosed AML patients, defined as the time from achievement of a remission (CR/CRh/CRi) following curative therapy (induction and consolidation), to relapse, or start of new therapy due to confirmed molecular relapse or death from any cause

    Measured: 16 months after inclusion of last patient

  7. Cumulative incidence of relapse (CIR) in newly diagnosed AML patients

    Cumulative incidence of relapse (CIR) in newly diagnosed AML patients

    Measured: 16 months after inclusion of last patient

  8. Cumulative incidence of death (CID)

    Cumulative incidence of death (CID) in newly diagnosed AML patients.

    Measured: 16 months after inclusion of last patient

  9. EQ-5D-5L questionnaire of the EuroQoL (EQ) group, among AML patients

    Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated using a 5 level (5L) scale from 1 (minimum) to 5 (maximum). Higher score values mean a worse outcome.

    Measured: at study entry, 2 months, 3 months, 6 months

  10. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) among AML patients

    All sub scales and single items have values from 1 (minimum) to 100 (maximum) points. A higher point value represents a better condition in terms of the functional scales and quality of life. In the symptomal sub scales a higher point value represents a worse condition.

    Measured: at study entry, 2 months, 3 months, 6 months

  11. Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue short form among AML patients

    The 7-item PROMIS Cancer Fatigue Short Form assesses the frequency of fatigue in the past seven days (7). Table 2 presents a list of the items. Items are measured on a five point scale (1 = never; 5 = always) and summed, after reverse scoring item 7, with higher scores indicating greater fatigue (worse condition).

    Measured: at study entry, 2 months, 3 months, 6 months

  12. CR/CRh rate

    Complete remission (CR/CRh) rate in newly diagnosed AML patients defined as the proportion of AML patients with CR/CRh after induction chemotherapy

    Measured: 2 months

  13. Rates of complete remission without measurable residual disease (CR/CRh MRD-) after induction therapy

    Rates of complete remission without measurable residual disease (CR/CRh MRD-) after induction therapy, defined as the proportion of AML patients achieving CR/CRh with negativity for a genetic marker by RT-qPCR, and/or with negativity by multi-color flow cytometry, if studied pre-treatment

    Measured: 2 months

  14. Rates of complete remission without measurable residual disease (CR/CRi MRD-) after induction therapy

    Rates of complete remission without measurable residual disease (CR/CRi MRD-) after induction therapy, defined as the proportion of AML patients achieving CR/CRi with negativity for a genetic marker by RT-qPCR, and/or with negativity by multi-color flow cytometry, if studied pre-treatment

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start13 Sep 2022
  3. Primary completionMar 2029 (estimated)
  4. Study completionFeb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628026
Sponsor's protocol ID
AMLSG31-19/HO501/AbbVieB18-982
Status last verified
Mar 2026
First submitted
3 Nov 2020
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax, Standard chemotherapy and Allogeneic stem cell transplantation in people with Acute Myeloid Leukemia, run by University of Ulm at 91 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Germany, Netherlands, Austria, Belgium, Norway and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hartmut Doehner, MD (004973150045501, harmut.doehner@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (EFS) (time frame: 6 months/16 months after inclusion of last patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04628026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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