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

December 29, 2025 updated by: Prof. Dr. Hartmut Doehner, University of Ulm

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 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)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz
        • Contact:
          • Armin Zebisch, Prof. Dr.
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medizinische Universität Innsbruck
        • Contact:
          • David Nachbaur, Prof. Dr.
      • Linz, Austria
        • Recruiting
        • Kepler Universitatsklinikum GmbH
        • Contact:
          • Clemens Schmitt, Prof.
      • Linz, Austria, 4020
        • Recruiting
        • Krankenhaus der Elisabethinen Linz GmbH
        • Contact:
          • Michael Girschikofsky, Dr.
      • Linz, Austria, 4010
        • Suspended
        • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
      • Rankweil, Austria, 6807
        • Recruiting
        • Landeskrankenhaus Feldkirch
        • Contact:
          • Bernd Hartmann, Dr.
      • Salzburg, Austria
        • Recruiting
        • Universitätsklinikum der PMU Landeskrankenhaus Salzburg
        • Contact:
          • Lisa Pleyer
      • Vienna, Austria, 1140
        • Recruiting
        • Hanuschkrankenhaus Wien
        • Contact:
          • Elisabeth Koller, Dr.
  • Germany
      • Aschaffenburg, Germany, 63739
        • Recruiting
        • Klinikum Aschaffenburg
        • Contact:
          • Manfred Welslau, Dr.
      • Augsburg, Germany, 86156
        • Suspended
        • Klinikum Augsburg
      • Aurich, Germany, 26603
        • Suspended
        • Ubbo-Emmius-Klinik Aurich
      • Bad Saarow, Germany, 15526
        • Recruiting
        • Helios Klinikum Bad Saarow
        • Contact:
          • Daniel Schöndube, Dr.med.
      • Berlin, Germany
        • Recruiting
        • Helios Klinikum Emil Von Behring
        • Contact:
          • Immanuel Merz
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinikum Am Urban
        • Contact:
          • Annette Dieing, Dr.
      • Berlin, Germany, 12351
        • Recruiting
        • Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln
        • Contact:
          • Maike De Wit, Prof. Dr. med.
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Universitatsmedizin Berlin Campus Virchow Klinikum
        • Contact:
          • Jörg Westermann, PD Dr.
      • Berlin, Germany
        • Recruiting
        • Vivantes Klinikum Spandau
        • Contact:
          • Joerg-Christian Rath, Dr.
      • Bochum, Germany, 44892
        • Recruiting
        • Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum
        • Contact:
          • Roland Schroers, Prof. Dr.
      • Bochum, Germany, 44791
        • Recruiting
        • Augusta-Kranken-Anstalt
        • Contact:
          • Stefan Lukic, Dr.
      • Bonn, Germany, 53105
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
          • Lino Teichmann, Dr.
      • Braunschweig, Germany, 38114
        • Recruiting
        • Städtisches Klinikum Braunschweig
        • Contact:
          • Jürgen Krauter, Prof. Dr.
      • Bremen, Germany, 28177
        • Recruiting
        • Klinikum Bremen-Mitte gGmbH
        • Contact:
          • Maher Hanoun, Prof. Dr. med.
      • Darmstadt, Germany, 64283
        • Recruiting
        • Klinikum Darmstadt
        • Contact:
          • Helga Bernhard, Prof. Dr. med.
      • Dortmund, Germany, 44137
        • Recruiting
        • St. Johannes Hospital
        • Contact:
          • Darina Kodzahbasheva, Dr.
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Contact:
          • Ulrich Germing, Prof.
      • Düsseldorf, Germany
        • Recruiting
        • Marien Hospital Dusseldorf GMBH
        • Contact:
          • Stefanie Groepper, Dr.
      • Essen, Germany, 45239
        • Recruiting
        • Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH
        • Contact:
          • Peter Reimer, Prof. Dr.
      • Esslingen am Neckar, Germany, 73730
        • Recruiting
        • Klinikum Esslingen GmbH
        • Contact:
          • Swen Wessendorf, PD Dr.
      • Flensburg, Germany, 24939
        • Recruiting
        • St. Franziskus Hospital
        • Contact:
          • Nicolai Faber, dr
      • Frankfurt, Germany, 65929
        • Recruiting
        • Städtische Kliniken Frankfurt am Main-Höchst
        • Contact:
          • Felicitas Scholten, Dr. med.
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Medizinische Universitätsklinik
        • Contact:
          • Michael Lübbert, Prof. Dr.
      • Fulda, Germany, 36043
        • Suspended
        • MVZ Osthessen Medizinisches Versorgungszentrum
      • Giessen, Germany, 35385
        • Recruiting
        • Klinik der Justus-Liebig-Universität
        • Contact:
          • Maisun Abu Samra, Dr.
      • Goch, Germany, 47574
        • Recruiting
        • Wilhelm-Anton-Hospital gGmbH
        • Contact:
          • Volker Runde, Prof. Dr. med.
      • Greifswald, Germany
        • Recruiting
        • Universitätsmedizin Greifswald
        • Contact:
          • Adrian Schwarzer, Prof.
      • Göppingen, Germany, 73035
        • Recruiting
        • Alb Fils Kliniken GmbH
        • Contact:
          • Martin Bommer, PD Dr.
      • Göttingen, Germany, 37075
        • Recruiting
        • Universitatsmedizin Gottingen
        • Contact:
          • Gerald Wulf, Prof. Dr.
      • Halle, Germany
        • Recruiting
        • Universitätsklinikum Hall
        • Contact:
          • Michael Heuser
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
        • Contact:
          • Hans Salwender, Dr.
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
          • Franziska Westendorf, Dr.
      • Hamburg, Germany
        • Recruiting
        • Asklepios Kliniken Hamburg GmbH St. Georg
        • Contact:
          • Ahmet Elmaagacli, Prof.
      • Hamm, Germany, 59063
        • Recruiting
        • Evangelisches Krankenhaus Hamm
        • Contact:
          • Alexander Baraniskin, Dr.
      • Hanau, Germany, 63450
        • Recruiting
        • Klinikum Hanau gGmbH
        • Contact:
          • Huesameddin Yildirim, Dr.
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Felicitas Thol, PD Dr.
      • Hanover, Germany, 30449
        • Recruiting
        • Klinikum Hannover Siloah
        • Contact:
          • Kim Marienhagen, Dr.
      • Heilbronn, Germany, 74078
        • Recruiting
        • SLK-Kliniken Heilbronn GmbH
        • Contact:
          • Uwe Martens, Prof. Dr.
      • Herne, Germany, 44625
        • Recruiting
        • Marienhospital Herne Klinikum der Ruhr-Universität Bochum
        • Contact:
          • Dirk Strumberg, Prof. Dr.
      • Homburg/Saar, Germany, 66424
        • Recruiting
        • Universitätsklinikum des Saarlandes
        • Contact:
          • Joerg Bittingbring, Dr.
      • Kaiserslautern, Germany, 67655
        • Recruiting
        • Westpfalz-Klinikum Kaiserslautern
        • Contact:
          • Gerhard HELD, Prof.
      • Karlsruhe, Germany, 76133
        • Recruiting
        • Stadtisches Klinikum Karlsruhe
        • Contact:
          • Martin Bentz, Prof. Dr.
      • Karlsruhe, Germany, 76137
        • Recruiting
        • St. Vincentius-Kliniken Karlsruhe
        • Contact:
          • Martina Gnadler
      • Kassel, Germany, 34125
        • Active, not recruiting
        • Klinikum Kassel Gmbh
      • Kiel, Germany, 24116
        • Suspended
        • Städtisches Krankenhaus Kiel GmbH
      • Krefeld, Germany
        • Recruiting
        • Helios Klinikum Krefeld
        • Contact:
          • Ali Nuri Hünerlitürkoglu, Dr.
      • Landshut, Germany, 84034
        • Recruiting
        • Klinikum Landshut gGmbH
        • Contact:
          • Christian Bogner, Dr.
      • Lebach, Germany, 66822
        • Recruiting
        • Caritas Krankenhaus Lebach
        • Contact:
          • Stephan Kremers, Dr. med.
      • Lemgo, Germany, 32657
        • Recruiting
        • Klinikum Lippe-Lemgo
        • Contact:
          • Frank Hartmann, Prof. Dr. med.
      • Ludwigshafen, Germany, 67063
        • Recruiting
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
        • Contact:
          • Martin Hoffmann, Dr.
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätslinikum Schleswig-Holstein, Lübeck
        • Contact:
          • Friederike Wortmann, Dr.
      • Lüdenscheid, Germany, 58515
        • Recruiting
        • Klinikum Lüdenscheid
        • Contact:
          • Monika Schwalenberg, Dr.
      • Magdeburg, Germany, 39120
        • Recruiting
        • Univ-Klinikum der Otto-von-Guericke-Universität
        • Contact:
          • Ana Maria Waldleben
      • Magdeburg, Germany, 39130
        • Recruiting
        • Klinikum Magdeburg gGmbH
        • Contact:
          • Christian Plate, Dr.
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsklinikum der Johannes Gutenberg-Universität Mainz
        • Contact:
          • Michael Kuehn, Dr.
      • Meschede, Germany, 59872
        • Recruiting
        • Klinikum Hochsauerland GmbH
        • Contact:
          • Mohammad Wattad, Dr.
      • Minden, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden
        • Contact:
          • Kai Wille, Dr.
      • Mutlangen, Germany, 73557
        • Recruiting
        • Klinikum Schwäbisch-Gmünd
        • Contact:
          • Holger Hebart, Prof. Dr. med.
      • Mühlheim, Germany, 45466
        • Recruiting
        • Evangelisches Krankenhaus Mülheim an der Ruhr GmbH
        • Contact:
          • Jan Schröder, Dr.
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar der TU München
        • Contact:
          • Katharina Götze, Prof. Dr.
      • München, Germany, 80804
        • Suspended
        • Klinikum Schwabing
      • Neuss, Germany, 41464
        • Suspended
        • Städtische Kliniken Neuss Lukaskrankenhaus GmbH
      • Offenbach, Germany, 63069
        • Recruiting
        • Sana Klinikum Offenbach
        • Contact:
          • Alexander Burchardt
      • Offenburg, Germany, 77654
        • Recruiting
        • Ortenau Klinikum, Offenburg-Gengenbach
        • Contact:
          • Irmgard Dresel, Dr.
      • Oldenburg, Germany, 26121
        • Recruiting
        • Pius Hospital Oldenburg
        • Contact:
          • Frank Griesinger, Prof. Dr.
      • Oldenburg, Germany, 26133
        • Recruiting
        • Klinikum Oldenburg gGmbH
        • Contact:
          • Andreas Voss, Dr.
      • Passau, Germany, 94032
        • Recruiting
        • Klinikum Passau
        • Contact:
          • Thomas Südhoff, Prof. Dr.
      • Potsdam, Germany, 14467
        • Recruiting
        • Ernst-von-Bergmann-Klinikum Potsdam gGmbH
        • Contact:
          • Su Hyeon Kim, Dr.
      • Recklinghausen, Germany, 45657
        • Recruiting
        • Klinikum Vest
        • Contact:
          • Michael Klein, Dr.
      • Regensburg, Germany, 93053
        • Recruiting
        • Universitätsklinikum
        • Contact:
          • Hendrik Poeck, Prof. Dr.
      • Rostock, Germany
        • Recruiting
        • University Hospital Rostock
        • Contact:
          • Christian Junghanss
      • Saarbrücken, Germany, 66113
        • Recruiting
        • Akademisches Lehrkrankenhaus des Saarlandes St. Theresia
        • Contact:
          • Julian Alexis Topaly
      • Saarlouis, Germany
        • Recruiting
        • Marienhaus Klinikum St. Elisaeth Saarlouis
        • Contact:
          • Katharina Graeber, Dr.
      • Sande, Germany
        • Recruiting
        • Nordwest-Krankenhaus Sanderbusch
        • Contact:
          • Detlev Kohl, Dr
      • Stuttgart, Germany, 70176
        • Recruiting
        • Diakonie-Klinikum Stuttgart
        • Contact:
          • Jochen Greiner, Prof. Dr.
      • Stuttgart, Germany, 70174
        • Recruiting
        • Klinikum Stuttgart Katharinenhospital
        • Contact:
          • Jan Schleicher, Dr. med.
      • Stuttgart, Germany, 70199
        • Recruiting
        • Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart
        • Contact:
          • Christian Jehn, Prof. Dr.
      • Traunstein, Germany, 83278
        • Recruiting
        • Klinikum Traunstein
        • Contact:
          • Thomas Kubin, Dr. med.
      • Trier, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
        • Contact:
          • Iordanis Deligiannis, Dr.
      • Trier, Germany, 54290
        • Recruiting
        • Klinikum Mutterhaus der Borromäerinnen gGmbH
        • Contact:
          • Tobias Buss, Dr. med.
      • Tübingen, Germany, 72076
        • Recruiting
        • Medizinische Universitätsklinik Tübingen
        • Contact:
          • Claudia Lengerke, Prof.
      • Ulm, Germany, 89081
      • Ulm, Germany, 89081
        • Recruiting
        • Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik
        • Contact:
          • Konstanze Döhner, Prof. Dr.
      • Villingen-Schwenningen, Germany, 78052
        • Recruiting
        • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
        • Contact:
          • Paul Graf La Rosee, Prof. Dr.
      • Wernigerode, Germany, 38855
        • Recruiting
        • Harzklinikum Dorothea Christiane Erxleben
        • Contact:
          • Heiko Hütten
      • Wuppertal, Germany, 42283
        • Recruiting
        • Helios Klinikum Wuppertal
        • Contact:
          • Silke Schostok, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 10 years
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])
10 years
Cumulative incidence of relapse
Time Frame: 10 years
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])
10 years
Cumulative incidence of death
Time Frame: 10 years
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])
10 years
Overall survival
Time Frame: 10 years
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])
10 years
Geographical representation
Time Frame: 1 day
Geographical representation of patients through collection of patients zip codes
1 day
incidence of disease-related genetic markers
Time Frame: 4 weeks
To perform rapid analyses of disease-related genetic markers (according to International Consensus Classification 2022) (incidences, treatment recommendations)
4 weeks
Treatment decision (intensive, non-intensive, investigational)
Time Frame: 1 year
To perform rapid analyses of disease-related genetic markers (according to ICC 2022) (incidences, treatment recommendations)
1 year
quality of life
Time Frame: 2 years
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.
2 years
Response to therapy
Time Frame: 1 year
Rate of response: complete remission (CR), CR with partial hematologic recovery (CRh); CR with incomplete hematologic recovery (CRi)
1 year
Relapse-free survival
Time Frame: 10 years
10 years
Measurable residual disease (MRD)
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Study Chair: Hartmut Döhner, Prof. Dr., University Hospital of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2010

Primary Completion (Estimated)

December 31, 2044

Study Completion (Estimated)

December 31, 2044

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimated)

December 3, 2010

Study Record Updates

Last Update Posted (Estimated)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMLSG BiO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia (AML)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe