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Acute Myeloid Leukemia (AML)AMLSG BiONCT01252485

Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project

An observational study of Acute Myeloid Leukemia (AML) and MDS/AML, run by University of Ulm at 94 sites in 2 countries.

Recruiting

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

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms Investigator's sites: 80-90 sites in Germany and Austria Estimated duration of observation of an individual patient: 10 years maximum Objectives To register all patients with AML and related neoplasms, newly… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML), MDS/AML
How many people
50,000 participants
Where
94 sitesin 2 countries
Study dates
6 Jul 2010to 31 Dec 2044
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with newly diagnosed or relapsed/refractory AML in all AMLSG participating centers (80-90 centers in Germany and Austria)

Who may be able to join

  • Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus Classification
  • Age ≥ 18 years. There is no upper age limit.
  • Signed written informed consent

Who cannot join

  • Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  • No consent for registration, storage and processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation
  • No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

Trial locations and contacts

94 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Hartmut Döhner, Prof. Dr. contact

49-731-500-45501

hartmut.doehner@uniklinik-ulm.de

94 sites in 2 countries

Germany86 sites, 79 recruiting
  • Klinikum Aschaffenburg

    Aschaffenburg, 63739

    Manfred Welslau, Dr.

    Recruiting
  • Klinikum Augsburg

    Augsburg, 86156

    Suspended
  • Ubbo-Emmius-Klinik Aurich

    Aurich, 26603

    Suspended
  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

    Daniel Schöndube, Dr.med.

    Recruiting
  • Vivantes Klinikum am Urban

    Berlin, 10967

    Annette Dieing, Dr.

    Recruiting
  • Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln

    Berlin, 12351

    Maike De Wit, Prof. Dr. med.

    Recruiting
  • Charité Universitätsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353

    Jörg Westermann, PD Dr.

    Recruiting
  • Helios Klinikum Emil von Behring

    Berlin

    Immanuel Merz

    Recruiting
  • Vivantes Klinikum Spandau

    Berlin

    Joerg-Christian Rath, Dr.

    Recruiting
  • Augusta-Kranken-Anstalt

    Bochum, 44791

    Stefan Lukic, Dr.

    Recruiting
  • Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum

    Bochum, 44892

    Roland Schroers, Prof. Dr.

    Recruiting
  • Universitätsklinikum Bonn

    Bonn, 53105

    Lino Teichmann, Dr.

    Recruiting
  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114

    Jürgen Krauter, Prof. Dr.

    Recruiting
  • Klinikum Bremen-Mitte gGmbH

    Bremen, 28177

    Maher Hanoun, Prof. Dr. med.

    Recruiting
  • Klinikum Darmstadt

    Darmstadt, 64283

    Helga Bernhard, Prof. Dr. med.

    Recruiting
  • St. Johannes Hospital

    Dortmund, 44137

    Darina Kodzahbasheva, Dr.

    Recruiting
  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

    Ulrich Germing, Prof.

    Recruiting
  • Marien Hospital Düsseldorf GmbH

    Düsseldorf

    Stefanie Groepper, Dr.

    Recruiting
  • Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH

    Essen, 45239

    Peter Reimer, Prof. Dr.

    Recruiting
  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

    Swen Wessendorf, PD Dr.

    Recruiting
  • St. Franziskus Hospital

    Flensburg, 24939

    Nicolai Faber, dr

    Recruiting
  • Städtische Kliniken Frankfurt am Main-Höchst

    Frankfurt, 65929

    Felicitas Scholten, Dr. med.

    Recruiting
  • Medizinische Universitätsklinik

    Freiburg im Breisgau, 79106

    Michael Lübbert, Prof. Dr.

    Recruiting
  • MVZ Osthessen Medizinisches Versorgungszentrum

    Fulda, 36043

    Suspended
  • Klinik der Justus-Liebig-Universität

    Giessen, 35385

    Maisun Abu Samra, Dr.

    Recruiting
  • Wilhelm-Anton-Hospital gGmbH

    Goch, 47574

    Volker Runde, Prof. Dr. med.

    Recruiting
  • Alb Fils Kliniken GmbH

    Göppingen, 73035

    Martin Bommer, PD Dr.

    Recruiting
  • Universitätsmedizin Göttingen

    Göttingen, 37075

    Gerald Wulf, Prof. Dr.

    Recruiting
  • Universitätsmedizin Greifswald

    Greifswald

    Adrian Schwarzer, Prof.

    Recruiting
  • Universitätsklinikum Hall

    Halle

    Michael Heuser

    Recruiting
  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Franziska Westendorf, Dr.

    Recruiting
  • Asklepios Klinik Altona

    Hamburg, 22763

    Hans Salwender, Dr.

    Recruiting
  • Asklepios Kliniken Hamburg GmbH St. Georg

    Hamburg

    Ahmet Elmaagacli, Prof.

    Recruiting
  • Evangelisches Krankenhaus Hamm

    Hamm, 59063

    Alexander Baraniskin, Dr.

    Recruiting
  • Klinikum Hanau gGmbH

    Hanau, 63450

    Huesameddin Yildirim, Dr.

    Recruiting
  • Klinikum Hannover Siloah

    Hanover, 30449

    Kim Marienhagen, Dr.

    Recruiting
  • Medizinische Hochschule Hannover

    Hanover, 30625

    Felicitas Thol, PD Dr.

    Recruiting
  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

    Uwe Martens, Prof. Dr.

    Recruiting
  • Marienhospital Herne Klinikum der Ruhr-Universität Bochum

    Herne, 44625

    Dirk Strumberg, Prof. Dr.

    Recruiting
  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66424

    Joerg Bittingbring, Dr.

    Recruiting
  • Westpfalz-Klinikum Kaiserslautern

    Kaiserslautern, 67655

    Gerhard Held, Prof.

    Recruiting
  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

    Martin Bentz, Prof. Dr.

    Recruiting
  • St. Vincentius-Kliniken Karlsruhe

    Karlsruhe, 76137

    Martina Gnadler

    Recruiting
  • Klinikum Kassel GmbH

    Kassel, 34125

    Active, not recruiting
  • Städtisches Krankenhaus Kiel GmbH

    Kiel, 24116

    Suspended
  • Helios Klinikum Krefeld

    Krefeld

    Ali Nuri Hünerlitürkoglu, Dr.

    Recruiting
  • Klinikum Landshut gGmbH

    Landshut, 84034

    Christian Bogner, Dr.

    Recruiting
  • Caritas Krankenhaus Lebach

    Lebach, 66822

    Stephan Kremers, Dr. med.

    Recruiting
  • Klinikum Lippe-Lemgo

    Lemgo, 32657

    Frank Hartmann, Prof. Dr. med.

    Recruiting
  • Universitätslinikum Schleswig-Holstein, Lübeck

    Lübeck, 23538

    Friederike Wortmann, Dr.

    Recruiting
  • Klinikum Lüdenscheid

    Lüdenscheid, 58515

    Monika Schwalenberg, Dr.

    Recruiting
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

    Martin Hoffmann, Dr.

    Recruiting
  • Univ-Klinikum der Otto-von-Guericke-Universität

    Magdeburg, 39120

    Ana Maria Waldleben

    Recruiting
  • Klinikum Magdeburg gGmbH

    Magdeburg, 39130

    Christian Plate, Dr.

    Recruiting
  • Universitätsklinikum der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

    Michael Kuehn, Dr.

    Recruiting
  • Klinikum Hochsauerland GmbH

    Meschede, 59872

    Mohammad Wattad, Dr.

    Recruiting
  • Johannes Wesling Klinikum Minden

    Minden, 32429

    Kai Wille, Dr.

    Recruiting
  • Evangelisches Krankenhaus Mülheim an der Ruhr GmbH

    Mühlheim, 45466

    Jan Schröder, Dr.

    Recruiting
  • Klinikum Schwabing

    München, 80804

    Suspended
  • Klinikum rechts der Isar der TU München

    München, 81675

    Katharina Götze, Prof. Dr.

    Recruiting
  • Klinikum Schwäbisch-Gmünd

    Mutlangen, 73557

    Holger Hebart, Prof. Dr. med.

    Recruiting
  • Städtische Kliniken Neuss Lukaskrankenhaus GmbH

    Neuss, 41464

    Suspended
  • Sana Klinikum Offenbach

    Offenbach, 63069

    Alexander Burchardt

    Recruiting
  • Ortenau Klinikum, Offenburg-Gengenbach

    Offenburg, 77654

    Irmgard Dresel, Dr.

    Recruiting
  • Pius Hospital Oldenburg

    Oldenburg, 26121

    Frank Griesinger, Prof. Dr.

    Recruiting
  • Klinikum Oldenburg gGmbH

    Oldenburg, 26133

    Andreas Voss, Dr.

    Recruiting
  • Klinikum Passau

    Passau, 94032

    Thomas Südhoff, Prof. Dr.

    Recruiting
  • Ernst-von-Bergmann-Klinikum Potsdam gGmbH

    Potsdam, 14467

    Su Hyeon Kim, Dr.

    Recruiting
  • Klinikum Vest

    Recklinghausen, 45657

    Michael Klein, Dr.

    Recruiting
  • Universitätsklinikum

    Regensburg, 93053

    Hendrik Poeck, Prof. Dr.

    Recruiting
  • University hospital Rostock

    Rostock

    Christian Junghanss

    Recruiting
  • Akademisches Lehrkrankenhaus des Saarlandes St. Theresia

    Saarbrücken, 66113

    Julian Alexis Topaly

    Recruiting
  • Marienhaus Klinikum St. Elisaeth Saarlouis

    Saarlouis

    Katharina Graeber, Dr.

    Recruiting
  • Nordwest-Krankenhaus Sanderbusch

    Sande

    Detlev Kohl, Dr

    Recruiting
  • Klinikum Stuttgart Katharinenhospital

    Stuttgart, 70174

    Jan Schleicher, Dr. med.

    Recruiting
  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176

    Jochen Greiner, Prof. Dr.

    Recruiting
  • Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart

    Stuttgart, 70199

    Christian Jehn, Prof. Dr.

    Recruiting
  • Klinikum Traunstein

    Traunstein, 83278

    Thomas Kubin, Dr. med.

    Recruiting
  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290

    Tobias Buss, Dr. med.

    Recruiting
  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

    Iordanis Deligiannis, Dr.

    Recruiting
  • Medizinische Universitätsklinik Tübingen

    Tübingen, 72076

    Claudia Lengerke, Prof.

    Recruiting
  • University Hospital of Ulm

    Ulm, 89081

    Hartmut Döhner, Prof. Dr., 49-731-500-45501, hartmut.doehner@uniklinik-ulm.de

    Recruiting
  • Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik

    Ulm, 89081

    Konstanze Döhner, Prof. Dr.

    Recruiting
  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78052

    Paul Graf La Rosee, Prof. Dr.

    Recruiting
  • Harzklinikum Dorothea Christiane Erxleben

    Wernigerode, 38855

    Heiko Hütten

    Recruiting
  • Helios Klinikum Wuppertal

    Wuppertal, 42283

    Silke Schostok, Dr.

    Recruiting

Other trials in Germany

Austria8 sites, 7 recruiting
  • Medizinische Universität Graz

    Graz, 8036

    Armin Zebisch, Prof. Dr.

    Recruiting
  • Medizinische Universität Innsbruck

    Innsbruck, 6020

    David Nachbaur, Prof. Dr.

    Recruiting
  • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

    Linz, 4010

    Suspended
  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, 4020

    Michael Girschikofsky, Dr.

    Recruiting
  • Kepler Universitätsklinikum GmbH

    Linz

    Clemens Schmitt, Prof.

    Recruiting
  • Landeskrankenhaus Feldkirch

    Rankweil, 6807

    Bernd Hartmann, Dr.

    Recruiting
  • Universitätsklinikum der PMU Landeskrankenhaus Salzburg

    Salzburg

    Lisa Pleyer

    Recruiting
  • Hanuschkrankenhaus Wien

    Vienna, 1140

    Elisabeth Koller, Dr.

    Recruiting

Other trials in Austria

About this study

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms

Investigator's sites: 80-90 sites in Germany and Austria

Read more

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

  • To register all patients with AML and related neoplasms, newly diagnosed or relapsed/refractory in all AMLSG participating centers (completeness)
  • To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations)
  • To assess patient and family history, as well as patient characteristics
  • To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival [EFS], relapse-free survival [RFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • To evaluate the impact of measurable residual disease (MRD) by different methods
  • To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
  • To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue; e.g., skin biopsy, finger nails, hairs, sputum, or urine)
Keywords
AML, Registry study, Biology and Outcome, MDS/AML
Medical subject headings
Leukemia, Myeloid, Acute

What is being measured

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

  1. incidence of disease-related genetic markers

    To perform rapid analyses of disease-related genetic markers (according to International Consensus Classification 2022) (incidences, treatment recommendations)

    Measured: 4 weeks

  2. Event-free survival

    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

    Measured: 10 years

  3. Cumulative incidence of relapse

    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

    Measured: 10 years

  4. Cumulative incidence of death

    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

    Measured: 10 years

  5. Overall survival

    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

    Measured: 10 years

  6. Treatment decision (intensive, non-intensive, investigational)

    To perform rapid analyses of disease-related genetic markers (according to ICC 2022) (incidences, treatment recommendations)

    Measured: 1 year

  7. quality of life

    Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, socioeconomics, and demographics according to Messerer D et al (2008), 6, 12 and 24 months after registration.

    Measured: 2 years

  8. Geographical representation

    Geographical representation of patients through collection of patients zip codes

    Measured: 1 day

  9. Response to therapy

    Rate of response: complete remission (CR), CR with partial hematologic recovery (CRh); CR with incomplete hematologic recovery (CRi)

    Measured: 1 year

  10. Relapse-free survival

    Measured: 10 years

  11. Measurable residual disease (MRD)

    Measured: 10 years

Timeline

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

  1. First posted3 Dec 2010 (estimated)
  2. Study start6 Jul 2010
  3. Primary completion31 Dec 2044 (estimated)
  4. Study completion31 Dec 2044 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252485
Sponsor's protocol ID
AMLSG BiO
Acronym
AMLSG BiO
Status last verified
Dec 2025
First submitted
2 Dec 2010
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia (AML) and MDS/AML, run by University of Ulm at 94 sites in 2 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 3 inclusion and 3 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Germany, Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Döhner, Prof. Dr. (49-731-500-45501, hartmut.doehner@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of disease-related genetic markers (time frame: 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Jan 2026.

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