Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
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
| Status | Recruiting |
| Enrollment | 15000 |
| Est. completion date | September 30, 2030 |
| Est. primary completion date | September 30, 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitätsklinikum Aachen | Aachen | Nordrhein-Westfalen |
| Germany | Klinikum Altenburger Land GmbH | Altenburg | Thüringen |
| Germany | Klinikum Augsburg | Augsburg | Bayern |
| Germany | Klinikum Mittelbaden | Baden-Baden | Baden-Württemberg |
| Germany | Sozialstiftung Bamberg | Bamberg | Bayern |
| Germany | Klinikum Bayreuth GmbH | Bayreuth | Bayern |
| Germany | Helios Klinikum Berlin-Buch | Berlin | |
| Germany | Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte | Bielefeld | Nordrhein-Westfalen |
| Germany | Augusta Kranken Anstalt Bochum | Bochum | Nordrhein-Westfalen |
| Germany | Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen | Bremen | |
| Germany | Klinikum Chemnitz gGmbH | Chemnitz | Sachsen |
| Germany | MVZ Klinikum Coburg GmbH | Coburg | Bayern |
| Germany | Carl-Thiem-Klinikum Cottbus gGmbH | Cottbus | Brandenburg |
| Germany | Universitätsklinikum Carl Gustav Carus | Dresden | Sachsen |
| Germany | Helios Klinikum Duisburg | Duisburg | Nordrhein-Westfalen |
| Germany | Krankenhaus Düren gGmbH | Düren | Nordrhein Westfalen |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | Nordrhein-Westfalen |
| Germany | Universitätsklinikum Erlangen | Erlangen | Bayern |
| Germany | Universitätsklinikum Essen | Essen | Nordrhein-Westfalen |
| Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | Hessen |
| Germany | Klinikum Frankfurt (Oder) GmbH | Frankfurt an der Oder | Brandenburg |
| Germany | Klinikum Fulda / MVZ Osthessen GmbH | Fulda | Hessen |
| Germany | Klinikum Gütersloh | Gütersloh | Nordrhein-Westfalen |
| Germany | Krankenhaus Martha-Maria Halle-Dölau | Halle (Saale) | Sachsen-Anhalt |
| Germany | Universitätsklinikum Halle (Saale) | Halle (Saale) | Sachsen-Anhalt |
| Germany | St. Barbara-Klinik Hamm GmbH | Hamm | Nordrhein-Westfalen |
| Germany | Universtitätsklinikum Heidelberg | Heidelberg | Baden-Württemberg |
| Germany | St. Bernward Krankenhaus Hildesheim | Hildesheim | Niedersachsen |
| Germany | Universitätsklinikum Jena | Jena | Thüringen |
| Germany | Städtisches Krankenhaus Kiel GmbH | Kiel | Schleswig-Holstein |
| Germany | Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein |
| Germany | Stiftungsklinikum Mittelrhein GmbH | Koblenz | Rheinland-Pfalz |
| Germany | Klinikum St. Georg gGmbH | Leipzig | Sachsen |
| Germany | Universitätsklinikum Leipzig | Leipzig | Sachsen |
| Germany | Klinikum Mannheim GmbH | Mannheim | Baden-Württemberg |
| Germany | Universitätsklinikum Gießen und Marburg | Marburg | Hessen |
| Germany | Universitätsklinikum Münster | Münster | Nordrhein-Westfalen |
| Germany | Diakonie Klinikum Dietrich Bonhoeffer | Neubrandenburg | Mecklenburg-Vorpommern |
| Germany | Klinikum Nürnberg | Nürnberg | Bayern |
| Germany | Elblandkliniken Stiftung & Co.KG | Riesa | Sachsen |
| Germany | Klinikum Südstadt Rostock | Rostock | Mecklenburg-Vorpommern |
| Germany | Agaplesion Diakonieklinikum Rotenburg | Rotenburg | Niedersachsen |
| Germany | Diakonie-Klinikum | Schwäbisch Hall | Baden-Württemberg |
| Germany | Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus | Siegen | Nordrhein-Westfalen |
| Germany | Marien Kliniken, St. Marien-Krankenhaus | Siegen | Nordhein-Westfalen |
| Germany | Kliniken Sindelfingen-Böblingen gGmbH | Sindelfingen | Baden-Württemberg |
| Germany | Johanniter-Krankenhaus Genthin-Stendal | Stendal | Sachsen-Anhalt |
| Germany | Robert-Bosch-Krankenhaus GmbH | Stuttgart | Baden-Württemberg |
| Germany | Dr. Horst Schmidt Kliniken GmbH | Wiesbaden | Hessen |
| Germany | Rems-Murr-Klinikum Winnenden | Winnenden | Baden-Württemberg |
| Germany | Universitätsklinikum Würzburg | Würzburg | Bayern |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität Dresden |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Epidemiological parameters | Epidemiological parameters | 10 years | |
| Primary | Relapse free survival (RFS) | Relapse free survival | 10 years | |
| Primary | Time to relapse (TTR), | Time to relapse (TTR), | 10 years | |
| Primary | Overall Survival (OS) | Overall Survival (OS) | 10 years | |
| Primary | cumulative incidence of relapse (CIR) | cumulative incidence of relapse (CIR) | 10 years | |
| Secondary | Complete Remission (CR) | Complete Remission | yearly follow up 10 years | |
| Secondary | Treatment related mortality (TRM) | Treatment related mortality | yearly follow up 10 years | |
| Secondary | Therapy-associated morbidity | grade IV toxicities | yearly follow up 10 years | |
| Secondary | Recording and evaluating the quality of therapy and diagnosis | Recording and evaluating the quality of therapy and diagnosis | 10 years | |
| Secondary | Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors | Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors | 10 years | |
| Secondary | Recording and describing new forms of therapy and new supportive measures | Recording and describing new forms of therapy and new supportive measures | 10 years |
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|---|---|---|---|
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