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

NCT01252485 | Recruiting

• 1 other identifier: AMLSG BiO
• Study Type: observational
• Target: 50,000
• Locations: 2 countries
• Sites: 94

Brief 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 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)

Conditions

Acute Myeloid Leukemia (AML); MDS/AML

Keywords

AML; Registry study; Biology and Outcome; MDS/AML

Outcome Measures

Primary Outcomes (11)

• incidence of disease-related genetic markers

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

  4 weeks

• 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 \[OS\])

  10 years

• 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 \[OS\])

  10 years

• 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 \[OS\])

  10 years

• 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 \[OS\])

  10 years

• Treatment decision (intensive, non-intensive, investigational)

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

  1 year

• 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.

  2 years

• Geographical representation

  Geographical representation of patients through collection of patients zip codes

  1 day

• Response to therapy

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

  1 year

• Relapse-free survival

  10 years

• Measurable residual disease (MRD)

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (94)

Medizinische Universität Graz

Graz, 8036, Austria

RECRUITING

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

RECRUITING

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

Linz, 4010, Austria

SUSPENDED

Krankenhaus der Elisabethinen Linz GmbH

Linz, 4020, Austria

RECRUITING

Kepler Universitätsklinikum GmbH

Linz, Austria

RECRUITING

Landeskrankenhaus Feldkirch

Rankweil, 6807, Austria

RECRUITING

Universitätsklinikum der PMU Landeskrankenhaus Salzburg

Salzburg, Austria

RECRUITING

Hanuschkrankenhaus Wien

Vienna, 1140, Austria

RECRUITING

Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

RECRUITING

Klinikum Augsburg

Augsburg, 86156, Germany

SUSPENDED

Ubbo-Emmius-Klinik Aurich

Aurich, 26603, Germany

SUSPENDED

Helios Klinikum Bad Saarow

Bad Saarow, 15526, Germany

RECRUITING

Vivantes Klinikum am Urban

Berlin, 10967, Germany

RECRUITING

Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln

Berlin, 12351, Germany

RECRUITING

Charité Universitätsmedizin Berlin Campus Virchow Klinikum

Berlin, 13353, Germany

RECRUITING

Helios Klinikum Emil von Behring

Berlin, Germany

RECRUITING

Vivantes Klinikum Spandau

Berlin, Germany

RECRUITING

Augusta-Kranken-Anstalt

Bochum, 44791, Germany

RECRUITING

Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum

Bochum, 44892, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, 53105, Germany

RECRUITING

Städtisches Klinikum Braunschweig

Braunschweig, 38114, Germany

RECRUITING

Klinikum Bremen-Mitte gGmbH

Bremen, 28177, Germany

RECRUITING

Klinikum Darmstadt

Darmstadt, 64283, Germany

RECRUITING

St. Johannes Hospital

Dortmund, 44137, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

RECRUITING

Marien Hospital Düsseldorf GmbH

Düsseldorf, Germany

RECRUITING

Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH

Essen, 45239, Germany

RECRUITING

Klinikum Esslingen GmbH

Esslingen am Neckar, 73730, Germany

RECRUITING

St. Franziskus Hospital

Flensburg, 24939, Germany

RECRUITING

Städtische Kliniken Frankfurt am Main-Höchst

Frankfurt, 65929, Germany

RECRUITING

Medizinische Universitätsklinik

Freiburg im Breisgau, 79106, Germany

RECRUITING

MVZ Osthessen Medizinisches Versorgungszentrum

Fulda, 36043, Germany

SUSPENDED

Klinik der Justus-Liebig-Universität

Giessen, 35385, Germany

RECRUITING

Wilhelm-Anton-Hospital gGmbH

Goch, 47574, Germany

RECRUITING

Alb Fils Kliniken GmbH

Göppingen, 73035, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

RECRUITING

Universitätsmedizin Greifswald

Greifswald, Germany

RECRUITING

Universitätsklinikum Hall

Halle, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, 22763, Germany

RECRUITING

Asklepios Kliniken Hamburg GmbH St. Georg

Hamburg, Germany

RECRUITING

Evangelisches Krankenhaus Hamm

Hamm, 59063, Germany

RECRUITING

Klinikum Hanau gGmbH

Hanau, 63450, Germany

RECRUITING

Klinikum Hannover Siloah

Hanover, 30449, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

SLK-Kliniken Heilbronn GmbH

Heilbronn, 74078, Germany

RECRUITING

Marienhospital Herne Klinikum der Ruhr-Universität Bochum

Herne, 44625, Germany

RECRUITING

Universitätsklinikum des Saarlandes

Homburg/Saar, 66424, Germany

RECRUITING

Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, 67655, Germany

RECRUITING

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

RECRUITING

St. Vincentius-Kliniken Karlsruhe

Karlsruhe, 76137, Germany

RECRUITING

Klinikum Kassel GmbH

Kassel, 34125, Germany

ACTIVE NOT RECRUITING

Städtisches Krankenhaus Kiel GmbH

Kiel, 24116, Germany

SUSPENDED

Helios Klinikum Krefeld

Krefeld, Germany

RECRUITING

Klinikum Landshut gGmbH

Landshut, 84034, Germany

RECRUITING

Caritas Krankenhaus Lebach

Lebach, 66822, Germany

RECRUITING

Klinikum Lippe-Lemgo

Lemgo, 32657, Germany

RECRUITING

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, 67063, Germany

RECRUITING

Universitätslinikum Schleswig-Holstein, Lübeck

Lübeck, 23538, Germany

RECRUITING

Klinikum Lüdenscheid

Lüdenscheid, 58515, Germany

RECRUITING

Univ-Klinikum der Otto-von-Guericke-Universität

Magdeburg, 39120, Germany

RECRUITING

Klinikum Magdeburg gGmbH

Magdeburg, 39130, Germany

RECRUITING

Universitätsklinikum der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

RECRUITING

Klinikum Hochsauerland GmbH

Meschede, 59872, Germany

RECRUITING

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

RECRUITING

Klinikum Schwäbisch-Gmünd

Mutlangen, 73557, Germany

RECRUITING

Evangelisches Krankenhaus Mülheim an der Ruhr GmbH

Mühlheim, 45466, Germany

RECRUITING

Klinikum Schwabing

München, 80804, Germany

SUSPENDED

Klinikum rechts der Isar der TU München

München, 81675, Germany

RECRUITING

Städtische Kliniken Neuss Lukaskrankenhaus GmbH

Neuss, 41464, Germany

SUSPENDED

Sana Klinikum Offenbach

Offenbach, 63069, Germany

RECRUITING

Ortenau Klinikum, Offenburg-Gengenbach

Offenburg, 77654, Germany

RECRUITING

Pius Hospital Oldenburg

Oldenburg, 26121, Germany

RECRUITING

Klinikum Oldenburg gGmbH

Oldenburg, 26133, Germany

RECRUITING

Klinikum Passau

Passau, 94032, Germany

RECRUITING

Ernst-von-Bergmann-Klinikum Potsdam gGmbH

Potsdam, 14467, Germany

RECRUITING

Klinikum Vest

Recklinghausen, 45657, Germany

RECRUITING

Universitätsklinikum

Regensburg, 93053, Germany

RECRUITING

University hospital Rostock

Rostock, Germany

RECRUITING

Akademisches Lehrkrankenhaus des Saarlandes St. Theresia

Saarbrücken, 66113, Germany

RECRUITING

Marienhaus Klinikum St. Elisaeth Saarlouis

Saarlouis, Germany

RECRUITING

Nordwest-Krankenhaus Sanderbusch

Sande, Germany

RECRUITING

Klinikum Stuttgart Katharinenhospital

Stuttgart, 70174, Germany

RECRUITING

Diakonie-Klinikum Stuttgart

Stuttgart, 70176, Germany

RECRUITING

Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart

Stuttgart, 70199, Germany

RECRUITING

Klinikum Traunstein

Traunstein, 83278, Germany

RECRUITING

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, 54290, Germany

RECRUITING

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, Germany

RECRUITING

Medizinische Universitätsklinik Tübingen

Tübingen, 72076, Germany

RECRUITING

University Hospital of Ulm

Ulm, 89081, Germany

RECRUITING

Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik

Ulm, 89081, Germany

RECRUITING

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78052, Germany

RECRUITING

Harzklinikum Dorothea Christiane Erxleben

Wernigerode, 38855, Germany

RECRUITING

Helios Klinikum Wuppertal

Wuppertal, 42283, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hartmut Döhner, Prof. Dr.

  University Hospital of Ulm

  STUDY CHAIR

Central Study Contacts

Hartmut Döhner, Prof. Dr.

CONTACT

49-731-500-45501; hartmut.doehner@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: July 6, 2010
• Primary Completion (Estimated): December 31, 2044
• Study Completion (Estimated): December 31, 2044
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

AU (8); DE (86)