Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
- Conditions
- Acute Myeloid Leukemia (AML)
- Registration Number
- NCT03188874
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
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
- Detailed Description
see brief summary
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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
- there are no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cumulative incidence of relapse (CIR) 10 years cumulative incidence of relapse (CIR)
Epidemiological parameters 10 years Epidemiological parameters
Overall Survival (OS) 10 years Overall Survival (OS)
Relapse free survival (RFS) 10 years Relapse free survival
Time to relapse (TTR), 10 years Time to relapse (TTR),
- Secondary Outcome Measures
Name Time Method Treatment related mortality (TRM) yearly follow up 10 years Treatment related mortality
Recording and evaluating the quality of therapy and diagnosis 10 years Recording and evaluating the quality of therapy and diagnosis
Complete Remission (CR) yearly follow up 10 years Complete Remission
Recording and describing new forms of therapy and new supportive measures 10 years Recording and describing new forms of therapy and new supportive measures
Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors 10 years Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors
Therapy-associated morbidity yearly follow up 10 years grade IV toxicities
Trial Locations
- Locations (51)
Klinikum Mittelbaden
🇩🇪Baden-Baden, Baden-Württemberg, Germany
Universtitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Klinikum Mannheim GmbH
🇩🇪Mannheim, Baden-Württemberg, Germany
Klinikum Augsburg
🇩🇪Augsburg, Bayern, Germany
Sozialstiftung Bamberg
🇩🇪Bamberg, Bayern, Germany
Diakonie-Klinikum
🇩🇪Schwäbisch Hall, Baden-Württemberg, Germany
Kliniken Sindelfingen-Böblingen gGmbH
🇩🇪Sindelfingen, Baden-Württemberg, Germany
Klinikum Bayreuth GmbH
🇩🇪Bayreuth, Bayern, Germany
MVZ Klinikum Coburg GmbH
🇩🇪Coburg, Bayern, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Bayern, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Bayern, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
🇩🇪Cottbus, Brandenburg, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt an der Oder, Brandenburg, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Hessen, Germany
Klinikum Fulda / MVZ Osthessen GmbH
🇩🇪Fulda, Hessen, Germany
Universitätsklinikum Gießen und Marburg
🇩🇪Marburg, Hessen, Germany
Dr. Horst Schmidt Kliniken GmbH
🇩🇪Wiesbaden, Hessen, Germany
Diakonie Klinikum Dietrich Bonhoeffer
🇩🇪Neubrandenburg, Mecklenburg-Vorpommern, Germany
Klinikum Südstadt Rostock
🇩🇪Rostock, Mecklenburg-Vorpommern, Germany
St. Bernward Krankenhaus Hildesheim
🇩🇪Hildesheim, Niedersachsen, Germany
Agaplesion Diakonieklinikum Rotenburg
🇩🇪Rotenburg, Niedersachsen, Germany
Marien Kliniken, St. Marien-Krankenhaus
🇩🇪Siegen, Nordhein-Westfalen, Germany
Universitätsklinikum Aachen
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte
🇩🇪Bielefeld, Nordrhein-Westfalen, Germany
Augusta Kranken Anstalt Bochum
🇩🇪Bochum, Nordrhein-Westfalen, Germany
Krankenhaus Düren gGmbH
🇩🇪Düren, Nordrhein Westfalen, Germany
Stiftungsklinikum Mittelrhein GmbH
🇩🇪Koblenz, Rheinland-Pfalz, Germany
Johanniter-Krankenhaus Genthin-Stendal
🇩🇪Stendal, Sachsen-Anhalt, Germany
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Helios Klinikum Duisburg
🇩🇪Duisburg, Nordrhein-Westfalen, Germany
Universitätsklinikum Halle (Saale)
🇩🇪Halle (Saale), Sachsen-Anhalt, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Klinikum Gütersloh
🇩🇪Gütersloh, Nordrhein-Westfalen, Germany
St. Barbara-Klinik Hamm GmbH
🇩🇪Hamm, Nordrhein-Westfalen, Germany
Krankenhaus Martha-Maria Halle-Dölau
🇩🇪Halle (Saale), Sachsen-Anhalt, Germany
Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus
🇩🇪Siegen, Nordrhein-Westfalen, Germany
Elblandkliniken Stiftung & Co.KG
🇩🇪Riesa, Sachsen, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Sachsen, Germany
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Klinikum St. Georg gGmbH
🇩🇪Leipzig, Sachsen, Germany
Städtisches Krankenhaus Kiel GmbH
🇩🇪Kiel, Schleswig-Holstein, Germany
Klinikum Altenburger Land GmbH
🇩🇪Altenburg, Thüringen, Germany
Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen
🇩🇪Bremen, Germany
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
Robert-Bosch-Krankenhaus GmbH
🇩🇪Stuttgart, Baden-Württemberg, Germany
Rems-Murr-Klinikum Winnenden
🇩🇪Winnenden, Baden-Württemberg, Germany