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

April 24, 2023 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: 60-70 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

  • To register all patients with acute myeloid leukemia and related precursor neoplasms, acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly diagnosed or relapsed/refractory in all participating centers (completeness)
  • To perform timely analyses of disease-related genetic markers (incidences, treatment recommendations)
  • To assess patient and family history, clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • 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, buccal swap, finger nails, hairs, or sputum)
  • To assess quality of life

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

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:
          • Heinz Sill, Prof. Dr.
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medizinische Universität Innsbruck
      • Linz, Austria
        • Recruiting
        • Kepler Universitätsklinikum GmbH
        • Contact:
          • Clemens Schmitt, Prof.
      • Linz, Austria, 4010
        • Recruiting
        • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
        • Contact:
          • Andreas Petzer, Prof. Dr.
      • Linz, Austria, 4020
        • Recruiting
        • Krankenhaus der Elisabethinen Linz GmbH
        • Contact:
          • Michael Girschikofsky, Dr.
      • Rankweil, Austria, 6807
        • Recruiting
        • Landeskrankenhaus Feldkirch
        • Contact:
          • Bernd Hartmann, Dr.
      • Salzburg, Austria, 5020
        • Recruiting
        • Universitätsklinikum der PMU Landeskrankenhaus Salzburg
        • Contact:
          • Richard Greil, Prof. Dr.
      • Wien, 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, 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
        • Charité Universitätsmedizin Berlin Campus Virchow Klinikum
        • Contact:
          • Jörg Westermann, PD Dr.
      • Berlin, Germany
        • Recruiting
        • Vivantes Klinikum Spandau
      • Bochum, Germany, 44892
        • Recruiting
        • Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum
        • Contact:
          • Wolf Schmiegel, Prof. 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:
          • Bernd Hertenstein, 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, Germany, 73730
        • Recruiting
        • Klinikum Esslingen GmbH
        • Contact:
          • Swen Wessendorf, PD Dr.
      • Flensburg, Germany, 24939
        • Recruiting
        • St. Franziskus Hospital
        • Contact:
          • Nadezda Basara, Prof. Dr.
      • Frankfurt, Germany, 65929
        • Recruiting
        • Städtische Kliniken Frankfurt am Main-Höchst
        • Contact:
          • Hans Günter Derigs, Prof. Dr. med.
      • Freiburg, 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:
          • Florian Heidel, 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.
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
        • Contact:
          • Hans Salwender, Dr.
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
          • Walter Fiedler, Prof. 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:
          • Andrea Sendler, Dr.
      • Hannover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Felicitas Thol, PD Dr.
      • Hannover, Germany, 30449
        • Recruiting
        • Klinikum Hannover Siloah
        • Contact:
          • Daniela Doerfel, 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:
          • Beate Schultheis, Dr.
      • Homburg/Saar, Germany, 66424
        • Recruiting
        • Universitätsklinikum des Saarlandes
        • Contact:
          • Joerg Bittingbring, Dr.
      • Kaiserslautern, Germany, 67655
        • Recruiting
        • Westpfalz-Klinikum Kaiserslautern
      • Karlsruhe, Germany, 76133
        • Recruiting
        • Städtisches Klinikum Karlsruhe
        • Contact:
          • Martin Bentz, Prof. Dr.
      • Karlsruhe, Germany, 76137
        • Recruiting
        • St. Vincentius-Kliniken Karlsruhe
        • Contact:
          • Martina Gnadler
      • Kiel, Germany, 24116
        • Suspended
        • Städtisches Krankenhaus Kiel GmbH
      • Krefeld, Germany
        • Recruiting
        • Helios Klinikum Krefeld
        • Contact:
          • Ali Nuri Hünerlitürkoglu, 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:
          • Gerhard Heil, Prof. Dr.
      • Magdeburg, Germany, 39120
        • Recruiting
        • Univ-Klinikum der Otto-von-Guericke-Universität
        • Contact:
          • Thomas Heinicke, 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:
          • Hans-Joachim Tischler, 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
      • München, Germany, 80804
        • Recruiting
        • Klinikum Schwabing
        • Contact:
          • Sabine Struve, Dr.
      • Neuss, Germany, 41464
        • Suspended
        • Städtische Kliniken Neuss Lukaskrankenhaus GmbH
      • 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:
          • Andrea Renzelmann, Dr.
      • Passau, Germany, 94032
        • Recruiting
        • Klinikum Passau
        • Contact:
          • Thomas Südhoff, Prof. Dr.
      • Recklinghausen, Germany, 45657
        • Recruiting
        • Klinikum Vest
        • Contact:
          • Michael Klein, Dr.
      • Regensburg, Germany, 93053
        • Recruiting
        • Universitätsklinikum
        • Contact:
          • Hendrik Poeck, Prof. Dr.
      • Saarbrücken, Germany, 66113
        • Recruiting
        • Akademisches Lehrkrankenhaus des Saarlandes St. Theresia
        • Contact:
          • Gregg Alexis Frost
      • Saarlouis, Germany
        • Recruiting
        • Marienhaus Klinikum St. Elisaeth Saarlouis
        • Contact:
          • Stephan Kremers, 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:
          • Claudio Denzlinger, Prof. Dr.
      • Traunstein, Germany, 83278
        • Recruiting
        • Klinikum Traunstein
        • Contact:
          • Thomas Kubin, Dr. med.
      • Trier, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
        • Contact:
          • Heinz Kirchen, Dr.
      • Trier, Germany, 54290
        • Recruiting
        • Klinikum Mutterhaus der Borromäerinnen gGmbH
        • Contact:
          • Rolf Mahlberg, Dr. med.
      • Tübingen, Germany, 72076
        • Recruiting
        • Medizinische Universitätsklinik Tübingen
        • Contact:
          • Maximilian Christopeit, Dr.
      • 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.
      • 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

16 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 (60-70 centers in Germany and Austria)

Description

Inclusion Criteria:

  • Patients with suspected diagnosis of AML and related precursor neoplasms, acute leukemias of ambiguous lineages, higher risk MDS (MDS with excess blasts 2 [MDS-EB2]), and myeloid neoplasm with germline predisposition, newly diagnosed or relapsed/refractory, classified according to the World Health Organization (WHO) 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
incidence of disease-related genetic markers
Time Frame: 4 weeks
To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
4 weeks
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
Treatment decision (intensive, non-intensive, investigational)
Time Frame: 1 year
To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
1 year
quality of life
Time Frame: 5 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) initially, in first CR, one year, 3 and 5 years after initial diagnosis.
5 years
Geographical representation
Time Frame: 1 day
Geographical representation of patients through collection of patients zip codes
1 day

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

July 1, 2010

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

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 Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe