Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

April 17, 2024 updated by: Technische Universität Dresden

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

Investigator's sites: 51 sites in Germany.

Primary objectives:

  • Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry.
  • Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS)
  • Documentation of treatment strategy

Study Overview

Status

Recruiting

Conditions

Detailed Description

see brief summary

Study Type

Observational

Enrollment (Estimated)

15000

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

  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • HELIOS Klinikum Berlin-Buch
        • Contact:
          • Bertram Glaß, Prof.
      • Bremen, Germany, 28239
        • Recruiting
        • Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen
        • Contact:
          • Ulrich Trappe, Prof. Dr.
    • Baden-Württemberg
      • Baden-Baden, Baden-Württemberg, Germany, 76532
        • Recruiting
        • Klinikum Mittelbaden
        • Contact:
          • Kai Neben, Prof.
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Recruiting
        • Universtitätsklinikum Heidelberg
        • Contact:
          • Carsten Müller-Tidow, Prof.
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Recruiting
        • Klinikum Mannheim GmbH
        • Contact:
          • Stefan Klein, PD Dr.
      • Schwäbisch Hall, Baden-Württemberg, Germany, 74523
        • Recruiting
        • Diakonie-Klinikum
        • Contact:
          • Thomas Geer, Dr.
      • Sindelfingen, Baden-Württemberg, Germany, 71065
        • Recruiting
        • Kliniken Sindelfingen-Böblingen gGmbH
        • Contact:
          • Markus Ritter, PD Dr.
      • Stuttgart, Baden-Württemberg, Germany, 70376
        • Recruiting
        • Robert-Bosch-Krankenhaus GmbH
        • Contact:
          • Martin Kaufmann, Dr.
      • Winnenden, Baden-Württemberg, Germany, 71364
        • Recruiting
        • Rems-Murr-Klinikum Winnenden
        • Contact:
          • Markus Schaich, Prof.
    • Bayern
      • Augsburg, Bayern, Germany, 86156
        • Recruiting
        • Klinikum Augsburg
        • Contact:
          • Andreas Rank, PD Dr.
      • Bamberg, Bayern, Germany, 96049
        • Recruiting
        • Sozialstiftung Bamberg
        • Contact:
          • Ruth Seggewiß-Bernhard, PD Dr.
      • Bayreuth, Bayern, Germany, 95445
        • Recruiting
        • Klinikum Bayreuth GmbH
        • Contact:
          • Alexander Kiani, Prof.
      • Coburg, Bayern, Germany, 96450
        • Recruiting
        • MVZ Klinikum Coburg GmbH
        • Contact:
          • Christof Lamberti, PD. Dr.
      • Erlangen, Bayern, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen
        • Contact:
          • Stefan Krause, Prof.
      • Nürnberg, Bayern, Germany, 90419
        • Recruiting
        • Klinikum Nürnberg
        • Contact:
          • Kerstin Schäfer-Eckart, Dr.
      • Würzburg, Bayern, Germany, 97080
        • Recruiting
        • Universitätsklinikum Würzburg
        • Contact:
          • Hermann Einsele, Prof.
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • Recruiting
        • Carl-Thiem-Klinikum Cottbus gGmbH
        • Contact:
          • Martin Schmidt-Hieber, PD Dr.
      • Frankfurt an der Oder, Brandenburg, Germany, 15236
        • Recruiting
        • Klinikum Frankfurt (Oder) GmbH
        • Contact:
          • Michael Kiehl, Prof.
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Recruiting
        • Universitatsklinikum Frankfurt
        • Contact:
          • Hubert Serve, Prof.
      • Fulda, Hessen, Germany, 36043
        • Recruiting
        • Klinikum Fulda / MVZ Osthessen GmbH
        • Contact:
          • Heinz-Gert Höffkes, Prof.
      • Marburg, Hessen, Germany, 35033
        • Recruiting
        • Universitätsklinikum Gießen und Marburg
        • Contact:
          • Andreas Neubauer, Prof.
      • Wiesbaden, Hessen, Germany, 65199
        • Recruiting
        • Dr. Horst Schmidt Kliniken GmbH
        • Contact:
          • Natalia Heinz, Dr.
    • Mecklenburg-Vorpommern
      • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
        • Recruiting
        • Diakonie Klinikum Dietrich Bonhoeffer
        • Contact:
          • Philipp Hemmati, PD Dr.
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • Recruiting
        • Klinikum Südstadt Rostock
        • Contact:
          • Beate Krammer-Steiner, Dr.
    • Niedersachsen
      • Hildesheim, Niedersachsen, Germany, 31134
        • Recruiting
        • St. Bernward Krankenhaus Hildesheim
        • Contact:
          • Ulrich Kaiser, Prof.
      • Rotenburg, Niedersachsen, Germany, 27956
        • Recruiting
        • Agaplesion Diakonieklinikum Rotenburg
        • Contact:
          • Achim Meinhardt, Dr.
    • Nordhein-Westfalen
      • Siegen, Nordhein-Westfalen, Germany, 57072
        • Recruiting
        • Marien Kliniken, St. Marien-Krankenhaus
        • Contact:
          • Winfried Gassmann, Prof. Dr.
    • Nordrhein Westfalen
      • Düren, Nordrhein Westfalen, Germany, 52351
        • Recruiting
        • Krankenhaus Düren gGmbH
        • Contact:
          • Michael Flaßhove, PD Dr.
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Recruiting
        • Universitätsklinikum Aachen
        • Contact:
          • Tim H. Brümmendorf, Prof.
      • Bielefeld, Nordrhein-Westfalen, Germany, 33604
        • Recruiting
        • Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte
        • Contact:
          • Martin Görner, PD Dr.
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • Recruiting
        • Augusta Kranken Anstalt Bochum
        • Contact:
          • Dirk Behringer, Prof.
      • Duisburg, Nordrhein-Westfalen, Germany, 47166
        • Recruiting
        • Helios Klinikum Duisburg
        • Contact:
          • Götz Ulrich Grigoleit, PD Dr.
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Contact:
          • Paul Jäger, Dr.
      • Essen, Nordrhein-Westfalen, Germany, 45747
        • Recruiting
        • Universitätsklinikum Essen
        • Contact:
          • Maher Hanoun, Dr.
      • Gütersloh, Nordrhein-Westfalen, Germany, 33332
        • Recruiting
        • Klinikum Gütersloh
        • Contact:
          • Gero Massenkeil, Prof.
      • Hamm, Nordrhein-Westfalen, Germany, 59075
        • Recruiting
        • St. Barbara-Klinik Hamm GmbH
        • Contact:
          • Heinz Dürk, Dr.
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • Universitatsklinikum Munster
        • Contact:
          • Wolfgang Berdel, Prof.
      • Siegen, Nordrhein-Westfalen, Germany, 57074
        • Recruiting
        • Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus
        • Contact:
          • Ralph Naumann, Prof. Dr.
        • Contact:
          • Martin Klump, Dr.
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • Recruiting
        • Stiftungsklinikum Mittelrhein GmbH
        • Contact:
          • Dirk Niemann, Dr.
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09113
        • Recruiting
        • Klinikum Chemnitz gGmbH
        • Contact:
          • Mathias Hänel, PD Dr.
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus
        • Contact:
          • Christoph Röllig, Prof.
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitatsklinikum Leipzig
        • Contact:
          • Madlen Jentzsch, PD Dr.
      • Leipzig, Sachsen, Germany, 04129
        • Recruiting
        • Klinikum St. Georg gGmbH
        • Contact:
          • Luisa Mantovani-Löffler, Dr.
      • Riesa, Sachsen, Germany, 01589
        • Recruiting
        • Elblandkliniken Stiftung & Co.KG
        • Contact:
          • Jörg Schubert, Prof.
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany, 06120
        • Recruiting
        • Universitatsklinikum Halle (Saale)
        • Contact:
          • Lutz Peter Müller, Prof.
      • Halle (Saale), Sachsen-Anhalt, Germany, 06120
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Dölau
        • Contact:
          • Wolfgang Schütte, Prof.
      • Stendal, Sachsen-Anhalt, Germany, 39576
        • Recruiting
        • Johanniter-Krankenhaus Genthin-Stendal
        • Contact:
          • Martin Mohren, PD Dr.
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
          • Claudia Baldus, Prof.
      • Kiel, Schleswig-Holstein, Germany, 24116
        • Recruiting
        • Städtisches Krankenhaus Kiel GmbH
        • Contact:
          • Roland Repp, Prof.
    • Thüringen
      • Altenburg, Thüringen, Germany, 04600
        • Recruiting
        • Klinikum Altenburger Land GmbH
        • Contact:
          • Romy Pomper, Dr.
      • Jena, Thüringen, Germany, 07740
        • Recruiting
        • Universitätsklinikum Jena
        • Contact:
          • Andreas Hochhaus, Prof.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with newly-diagnosed AML, including acute promyelocytic leukemia (APL)

Description

Inclusion Criteria:

  • AML according to the WHO (World Health Organization) diagnostic criteria, including acute promyelocytic leukemia
  • Age ≥ 18 years. There is no upper age limit.
  • Signed written informed consent

Exclusion Criteria:

  • there are no exclusion criteria

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological parameters
Time Frame: 10 years
Epidemiological parameters
10 years
Relapse free survival (RFS)
Time Frame: 10 years
Relapse free survival
10 years
Time to relapse (TTR),
Time Frame: 10 years
Time to relapse (TTR),
10 years
Overall Survival (OS)
Time Frame: 10 years
Overall Survival (OS)
10 years
cumulative incidence of relapse (CIR)
Time Frame: 10 years
cumulative incidence of relapse (CIR)
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission (CR)
Time Frame: yearly follow up 10 years
Complete Remission
yearly follow up 10 years
Treatment related mortality (TRM)
Time Frame: yearly follow up 10 years
Treatment related mortality
yearly follow up 10 years
Therapy-associated morbidity
Time Frame: yearly follow up 10 years
grade IV toxicities
yearly follow up 10 years
Recording and evaluating the quality of therapy and diagnosis
Time Frame: 10 years
Recording and evaluating the quality of therapy and diagnosis
10 years
Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors
Time Frame: 10 years
Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors
10 years
Recording and describing new forms of therapy and new supportive measures
Time Frame: 10 years
Recording and describing new forms of therapy and new supportive measures
10 years

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Investigators

  • Study Director: Christoph Röllig, Prof. Dr., Universitätsklinikum Carl Gustav Carus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

September 1, 2010

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAL-AML-REG-BIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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