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

NCT ID: NCT01252485

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-06

Study Completion Date

2044-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia (AML) MDS/AML

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Hartmut Doehner

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hartmut Döhner, Prof. Dr.

Role: STUDY_CHAIR

University Hospital of Ulm

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medizinische Universität Graz

Graz, , Austria

Site Status RECRUITING

Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

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

Linz, , Austria

Site Status SUSPENDED

Krankenhaus der Elisabethinen Linz GmbH

Linz, , Austria

Site Status RECRUITING

Kepler Universitätsklinikum GmbH

Linz, , Austria

Site Status RECRUITING

Landeskrankenhaus Feldkirch

Rankweil, , Austria

Site Status RECRUITING

Universitätsklinikum der PMU Landeskrankenhaus Salzburg

Salzburg, , Austria

Site Status RECRUITING

Hanuschkrankenhaus Wien

Vienna, , Austria

Site Status RECRUITING

Klinikum Aschaffenburg

Aschaffenburg, , Germany

Site Status RECRUITING

Klinikum Augsburg

Augsburg, , Germany

Site Status SUSPENDED

Ubbo-Emmius-Klinik Aurich

Aurich, , Germany

Site Status SUSPENDED

Helios Klinikum Bad Saarow

Bad Saarow, , Germany

Site Status RECRUITING

Vivantes Klinikum am Urban

Berlin, , Germany

Site Status RECRUITING

Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln

Berlin, , Germany

Site Status RECRUITING

Charité Universitätsmedizin Berlin Campus Virchow Klinikum

Berlin, , Germany

Site Status RECRUITING

Helios Klinikum Emil von Behring

Berlin, , Germany

Site Status RECRUITING

Vivantes Klinikum Spandau

Berlin, , Germany

Site Status RECRUITING

Augusta-Kranken-Anstalt

Bochum, , Germany

Site Status RECRUITING

Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum

Bochum, , Germany

Site Status RECRUITING

Universitätsklinikum Bonn

Bonn, , Germany

Site Status RECRUITING

Städtisches Klinikum Braunschweig

Braunschweig, , Germany

Site Status RECRUITING

Klinikum Bremen-Mitte gGmbH

Bremen, , Germany

Site Status RECRUITING

Klinikum Darmstadt

Darmstadt, , Germany

Site Status RECRUITING

St. Johannes Hospital

Dortmund, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Marien Hospital Düsseldorf GmbH

Düsseldorf, , Germany

Site Status RECRUITING

Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH

Essen, , Germany

Site Status RECRUITING

Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Site Status RECRUITING

St. Franziskus Hospital

Flensburg, , Germany

Site Status RECRUITING

Städtische Kliniken Frankfurt am Main-Höchst

Frankfurt, , Germany

Site Status RECRUITING

Medizinische Universitätsklinik

Freiburg im Breisgau, , Germany

Site Status RECRUITING

MVZ Osthessen Medizinisches Versorgungszentrum

Fulda, , Germany

Site Status SUSPENDED

Klinik der Justus-Liebig-Universität

Giessen, , Germany

Site Status RECRUITING

Wilhelm-Anton-Hospital gGmbH

Goch, , Germany

Site Status RECRUITING

Alb Fils Kliniken GmbH

Göppingen, , Germany

Site Status RECRUITING

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status RECRUITING

Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status RECRUITING

Universitätsklinikum Hall

Halle, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Asklepios Klinik Altona

Hamburg, , Germany

Site Status RECRUITING

Asklepios Kliniken Hamburg GmbH St. Georg

Hamburg, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Hamm

Hamm, , Germany

Site Status RECRUITING

Klinikum Hanau gGmbH

Hanau, , Germany

Site Status RECRUITING

Klinikum Hannover Siloah

Hanover, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

SLK-Kliniken Heilbronn GmbH

Heilbronn, , Germany

Site Status RECRUITING

Marienhospital Herne Klinikum der Ruhr-Universität Bochum

Herne, , Germany

Site Status RECRUITING

Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Site Status RECRUITING

Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, , Germany

Site Status RECRUITING

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status RECRUITING

St. Vincentius-Kliniken Karlsruhe

Karlsruhe, , Germany

Site Status RECRUITING

Klinikum Kassel GmbH

Kassel, , Germany

Site Status ACTIVE_NOT_RECRUITING

Städtisches Krankenhaus Kiel GmbH

Kiel, , Germany

Site Status SUSPENDED

Helios Klinikum Krefeld

Krefeld, , Germany

Site Status RECRUITING

Klinikum Landshut gGmbH

Landshut, , Germany

Site Status RECRUITING

Caritas Krankenhaus Lebach

Lebach, , Germany

Site Status RECRUITING

Klinikum Lippe-Lemgo

Lemgo, , Germany

Site Status RECRUITING

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, , Germany

Site Status RECRUITING

Universitätslinikum Schleswig-Holstein, Lübeck

Lübeck, , Germany

Site Status RECRUITING

Klinikum Lüdenscheid

Lüdenscheid, , Germany

Site Status RECRUITING

Univ-Klinikum der Otto-von-Guericke-Universität

Magdeburg, , Germany

Site Status RECRUITING

Klinikum Magdeburg gGmbH

Magdeburg, , Germany

Site Status RECRUITING

Universitätsklinikum der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status RECRUITING

Klinikum Hochsauerland GmbH

Meschede, , Germany

Site Status RECRUITING

Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status RECRUITING

Klinikum Schwäbisch-Gmünd

Mutlangen, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Mülheim an der Ruhr GmbH

Mühlheim, , Germany

Site Status RECRUITING

Klinikum Schwabing

München, , Germany

Site Status SUSPENDED

Klinikum rechts der Isar der TU München

München, , Germany

Site Status RECRUITING

Städtische Kliniken Neuss Lukaskrankenhaus GmbH

Neuss, , Germany

Site Status SUSPENDED

Sana Klinikum Offenbach

Offenbach, , Germany

Site Status RECRUITING

Ortenau Klinikum, Offenburg-Gengenbach

Offenburg, , Germany

Site Status RECRUITING

Pius Hospital Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

Klinikum Oldenburg gGmbH

Oldenburg, , Germany

Site Status RECRUITING

Klinikum Passau

Passau, , Germany

Site Status RECRUITING

Ernst-von-Bergmann-Klinikum Potsdam gGmbH

Potsdam, , Germany

Site Status RECRUITING

Klinikum Vest

Recklinghausen, , Germany

Site Status RECRUITING

Universitätsklinikum

Regensburg, , Germany

Site Status RECRUITING

University hospital Rostock

Rostock, , Germany

Site Status RECRUITING

Akademisches Lehrkrankenhaus des Saarlandes St. Theresia

Saarbrücken, , Germany

Site Status RECRUITING

Marienhaus Klinikum St. Elisaeth Saarlouis

Saarlouis, , Germany

Site Status RECRUITING

Nordwest-Krankenhaus Sanderbusch

Sande, , Germany

Site Status RECRUITING

Klinikum Stuttgart Katharinenhospital

Stuttgart, , Germany

Site Status RECRUITING

Diakonie-Klinikum Stuttgart

Stuttgart, , Germany

Site Status RECRUITING

Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart

Stuttgart, , Germany

Site Status RECRUITING

Klinikum Traunstein

Traunstein, , Germany

Site Status RECRUITING

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, , Germany

Site Status RECRUITING

Krankenhaus der Barmherzigen Brüder Trier

Trier, , Germany

Site Status RECRUITING

Medizinische Universitätsklinik Tübingen

Tübingen, , Germany

Site Status RECRUITING

University Hospital of Ulm

Ulm, , Germany

Site Status RECRUITING

Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik

Ulm, , Germany

Site Status RECRUITING

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, , Germany

Site Status RECRUITING

Harzklinikum Dorothea Christiane Erxleben

Wernigerode, , Germany

Site Status RECRUITING

Helios Klinikum Wuppertal

Wuppertal, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hartmut Döhner, Prof. Dr.

Role: CONTACT

49-731-500-45501

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Armin Zebisch, Prof. Dr.

Role: primary

David Nachbaur, Prof. Dr.

Role: primary

Michael Girschikofsky, Dr.

Role: primary

Clemens Schmitt, Prof.

Role: primary

Bernd Hartmann, Dr.

Role: primary

Lisa Pleyer

Role: primary

Elisabeth Koller, Dr.

Role: primary

Manfred Welslau, Dr.

Role: primary

Daniel Schöndube, Dr.med.

Role: primary

Annette Dieing, Dr.

Role: primary

Maike De Wit, Prof. Dr. med.

Role: primary

Jörg Westermann, PD Dr.

Role: primary

Immanuel Merz

Role: primary

Joerg-Christian Rath, Dr.

Role: primary

Stefan Lukic, Dr.

Role: primary

Roland Schroers, Prof. Dr.

Role: primary

Lino Teichmann, Dr.

Role: primary

Jürgen Krauter, Prof. Dr.

Role: primary

Maher Hanoun, Prof. Dr. med.

Role: primary

Helga Bernhard, Prof. Dr. med.

Role: primary

Darina Kodzahbasheva, Dr.

Role: primary

Ulrich Germing, Prof.

Role: primary

Stefanie Groepper, Dr.

Role: primary

Peter Reimer, Prof. Dr.

Role: primary

Swen Wessendorf, PD Dr.

Role: primary

Nicolai Faber, dr

Role: primary

Felicitas Scholten, Dr. med.

Role: primary

Michael Lübbert, Prof. Dr.

Role: primary

Maisun Abu Samra, Dr.

Role: primary

Volker Runde, Prof. Dr. med.

Role: primary

Martin Bommer, PD Dr.

Role: primary

Gerald Wulf, Prof. Dr.

Role: primary

Adrian Schwarzer, Prof.

Role: primary

Michael Heuser

Role: primary

Franziska Westendorf, Dr.

Role: primary

Hans Salwender, Dr.

Role: primary

Ahmet Elmaagacli, Prof.

Role: primary

Alexander Baraniskin, Dr.

Role: primary

Huesameddin Yildirim, Dr.

Role: primary

Kim Marienhagen, Dr.

Role: primary

Felicitas Thol, PD Dr.

Role: primary

Uwe Martens, Prof. Dr.

Role: primary

Dirk Strumberg, Prof. Dr.

Role: primary

Joerg Bittingbring, Dr.

Role: primary

Gerhard Held, Prof.

Role: primary

Martin Bentz, Prof. Dr.

Role: primary

Martina Gnadler

Role: primary

Ali Nuri Hünerlitürkoglu, Dr.

Role: primary

Christian Bogner, Dr.

Role: primary

Stephan Kremers, Dr. med.

Role: primary

Frank Hartmann, Prof. Dr. med.

Role: primary

Martin Hoffmann, Dr.

Role: primary

Friederike Wortmann, Dr.

Role: primary

Monika Schwalenberg, Dr.

Role: primary

Ana Maria Waldleben

Role: primary

Christian Plate, Dr.

Role: primary

Michael Kuehn, Dr.

Role: primary

Mohammad Wattad, Dr.

Role: primary

Kai Wille, Dr.

Role: primary

Holger Hebart, Prof. Dr. med.

Role: primary

Jan Schröder, Dr.

Role: primary

Katharina Götze, Prof. Dr.

Role: primary

Alexander Burchardt

Role: primary

Irmgard Dresel, Dr.

Role: primary

Frank Griesinger, Prof. Dr.

Role: primary

Andreas Voss, Dr.

Role: primary

Thomas Südhoff, Prof. Dr.

Role: primary

Su Hyeon Kim, Dr.

Role: primary

Michael Klein, Dr.

Role: primary

Hendrik Poeck, Prof. Dr.

Role: primary

Christian Junghanss

Role: primary

Julian Alexis Topaly

Role: primary

Katharina Graeber, Dr.

Role: primary

Detlev Kohl, Dr

Role: primary

Jan Schleicher, Dr. med.

Role: primary

Jochen Greiner, Prof. Dr.

Role: primary

Christian Jehn, Prof. Dr.

Role: primary

Thomas Kubin, Dr. med.

Role: primary

Tobias Buss, Dr. med.

Role: primary

Iordanis Deligiannis, Dr.

Role: primary

Claudia Lengerke, Prof.

Role: primary

Hartmut Döhner, Prof. Dr.

Role: primary

49-731-500-45501

Konstanze Döhner, Prof. Dr.

Role: primary

Paul Graf La Rosee, Prof. Dr.

Role: primary

Heiko Hütten

Role: primary

Silke Schostok, Dr.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMLSG BiO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.