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.
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
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.
91 sites in 8 countries
Germany50 sites, 48 recruiting
- 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.
- Not yet recruiting
Vivantes am Urban
Berlin
Hannes Kroenlein
- Not yet recruiting
Vivantes Neukölln
Berlin
Maike de Wit
- Withdrawn
Vivantes Spandau
Berlin
- Recruiting
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
- Not yet recruiting
Klinikum Darmstadt GmbH
Darmstadt
Helga Bernhard
- Recruiting
St. Johannes Hospital Dortmund
Dortmund
Eva Schulte
- Withdrawn
Marien Hospital Duesseldorf GmbH
Düsseldorf
- Recruiting
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
Michael Heuser, Prof.
- 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.
- Not yet recruiting
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe
Mark, Ringhoffer
- 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
Netherlands20 sites, 20 recruiting
- 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
Austria6 sites, 6 recruiting
- Not yet recruiting
Tirol Kliniken GmbH
Innsbruck
David Nachbaur
- Not yet recruiting
Kepler Universitaetsklinikum GmbH
Linz
Clemens Schmitt
- Recruiting
Ordensklinikum Linz GmbH
Linz
Sigrid Machherndl-Spandl
- Recruiting
Landeskrankenhaus (LKH) Rankweil, Interne E am Landeskrankenhaus Rankweil
Rankweil
Bernd Hartmann
- Not yet recruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Salzburg
Lisa Pleyer
- Recruiting
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Vienna
Elisabeth Koller
Belgium6 sites, 6 recruiting
- Not yet recruiting
Ziekenhuis Aan De Stroom
Antwerp
D. Breems
- Recruiting
Az St-Jan Brugge-Oostende A.V.
Bruges
T. Lodewyck
- Recruiting
Universitair Ziekenhuis Brussel
Brussels
A. de Becker
- Not yet recruiting
Katholieke Universiteit te Leuven
Leuven
J. Maertens
- Recruiting
Algemeen Ziekenhuis Delta
Roeselare
D. Deeren
- Recruiting
CHU UCL NAMUR - Mont Godinne
Yvoir
E. Collinge
Norway4 sites, 4 recruiting
- Not yet recruiting
Haukeland University Hospital
Bergen
O. Sefland
- Not yet recruiting
Stavanger Univ. Hosp.-Rogaland Hosp.
Oslo
A. Lenartova
- Not yet recruiting
University Hospital of North Norway
Tromsø
N. Leknes
- Recruiting
St. Olavs Hospital
Trondheim
A. von Krogh
Estonia2 sites, 2 recruiting
- Recruiting
North Estonia Medical Centre Foundation
Tallinn
K. Palk
- Recruiting
Tartu University Hospital
Tartu
A. Kaare
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Central Hospital Meilahden Kolmiosairaala
Helsinki
M. Kontro
- Not yet recruiting
Tampere University Hospital
Tampere
J. Rimpilainen
Lithuania1 site, 1 recruiting
- Not yet recruiting
Vilnius University Hospital Santaros Klinik
Vilnius
A. Zucenka
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).
- Conditions
- Acute Myeloid Leukemia
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | standard chemotherapy in combination with venetoclax Receives: Drug: Venetoclax; Combination Product: Standard chemotherapy; Other: Allogeneic stem cell transplantation |
| 2 | Placebo comparator | standard 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.
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
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)
Overall Survival (OS)
OS in patients with newly diagnosed AML
Measured: 6 months/16 months/28 months after inclusion of last patient
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
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
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
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
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
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
Cumulative incidence of death (CID)
Cumulative incidence of death (CID) in newly diagnosed AML patients.
Measured: 16 months after inclusion of last patient
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
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
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
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
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
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.
- First posted13 Nov 2020
- Study start13 Sep 2022
- Primary completionMar 2029 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Responsible party
- Principal investigator, Prof. Dr. Hartmut Doehner, University of Ulm
- Investigators
- Hartmut Doehner, MD, Principal investigator, University of Ulm
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
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No