Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
1 other identifier
observational
15,000
1 country
60
Brief Summary
This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia. Investigator's sites: 60 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
April 21, 2026
April 1, 2026
20.1 years
March 1, 2017
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Epidemiological parameters
Epidemiological parameters
10 years
Relapse free survival (RFS)
Relapse free survival
10 years
Time to relapse (TTR),
Time to relapse (TTR),
10 years
Overall Survival (OS)
Overall Survival (OS)
10 years
cumulative incidence of relapse (CIR)
cumulative incidence of relapse (CIR)
10 years
Secondary Outcomes (6)
Complete Remission (CR)
yearly follow up 10 years
Treatment related mortality (TRM)
yearly follow up 10 years
Therapy-associated morbidity
yearly follow up 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
10 years
- +1 more secondary outcomes
Eligibility Criteria
Patients with newly-diagnosed AML, including acute promyelocytic leukemia (APL)
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Klinikum Mittelbaden
Baden-Baden, Baden-Wurttemberg, 76532, Germany
Universtitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Klinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167, Germany
Diakonie-Klinikum
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
Kliniken Sindelfingen-Böblingen gGmbH
Sindelfingen, Baden-Wurttemberg, 71065, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, Baden-Wurttemberg, 70376, Germany
Rems-Murr-Klinikum Winnenden
Winnenden, Baden-Wurttemberg, 71364, Germany
Klinikum Augsburg
Augsburg, Bavaria, 86156, Germany
Sozialstiftung Bamberg
Bamberg, Bavaria, 96049, Germany
Klinikum Bayreuth GmbH
Bayreuth, Bavaria, 95445, Germany
MVZ Klinikum Coburg GmbH
Coburg, Bavaria, 96450, Germany
ONKO Medeor Onkologische Zentren
Donauwörth, Bavaria, 86609, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Klinikum Nürnberg
Nuremberg, Bavaria, 90419, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, Brandenburg, 03048, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Brandenburg, 15236, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Klinikum Fulda / MVZ Osthessen GmbH
Fulda, Hesse, 36043, Germany
Universitätsklinikum Gießen und Marburg
Marburg, Hesse, 35033, Germany
Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, Hesse, 65199, Germany
St. Bernward Krankenhaus Hildesheim
Hildesheim, Lower Saxony, 31134, Germany
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), Lower Saxony, 27956, Germany
Klinikum Wolfsburg
Wolfsburg, Lower Saxony, 38440, Germany
Diakonie Klinikum Dietrich Bonhoeffer
Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany
Klinikum Südstadt Rostock
Rostock, Mecklenburg-Vorpommern, 18059, Germany
HELIOS Klinikum Schwerin
Schwerin, Mecklenburg-Vorpommern, 10955, Germany
Marien Kliniken, St. Marien-Krankenhaus
Siegen, Nordhein-Westfalen, 57072, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte
Bielefeld, North Rhine-Westphalia, 33604, Germany
Augusta Kranken Anstalt Bochum
Bochum, North Rhine-Westphalia, 44791, Germany
Klinikum der Universität zu Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Helios Klinikum Duisburg
Duisburg, North Rhine-Westphalia, 47166, Germany
Helios Klinikum Duisburg
Duisburg, North Rhine-Westphalia, 47228, Germany
Krankenhaus Düren gGmbH
Düren, North Rhine-Westphalia, 52351, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Alfried Krupp Krankenhaus Rüttenscheid
Essen, North Rhine-Westphalia, 45131, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45747, Germany
Klinikum Gütersloh
Gütersloh, North Rhine-Westphalia, 33332, Germany
St. Barbara-Klinik Hamm GmbH
Hamm, North Rhine-Westphalia, 59075, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus
Siegen, North Rhine-Westphalia, 57074, Germany
Stiftungsklinikum Mittelrhein GmbH
Koblenz, Rhineland-Palatinate, 56068, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09113, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Klinikum St. Georg gGmbH
Leipzig, Saxony, 04129, Germany
Elblandkliniken Stiftung & Co.KG
Riesa, Saxony, 01589, Germany
Heinrich-Braun-Klinikum gGmbH
Zwickau, Saxony, 08060, Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, Saxony-Anhalt, 06120, Germany
Universitätsklinikum Halle (Saale)
Halle, Saxony-Anhalt, 06120, Germany
Johanniter-Krankenhaus Genthin-Stendal
Stendal, Saxony-Anhalt, 39576, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Städtisches Krankenhaus Kiel GmbH
Kiel, Schleswig-Holstein, 24116, Germany
Alexianer St. Hedwig-Krankenhaus
Berlin, State of Berlin, 10115, Germany
Helios Klinikum Berlin-Buch
Berlin, State of Berlin, 13125, Germany
Klinikum Altenburger Land GmbH
Altenburg, Thuringia, 04600, Germany
Helios Klinikum Erfurt
Erfurt, Thuringia, 99089, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07740, Germany
Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen
Bremen, 28239, Germany
Related Publications (3)
Hanoun M, Ruhnke L, Kramer M, Hanoun C, Schafer-Eckart K, Steffen B, Sauer T, Krause SW, Schliemann C, Mikesch JH, Kaufmann M, Hanel M, Jost E, Brummendorf TH, Fransecky L, Kraus S, Einsele H, Niemann D, Neubauer A, Kullmer J, Seggewiss-Bernhard R, Gorner M, Held G, Kaiser U, Scholl S, Hochhaus A, Reinhardt HC, Platzbecker U, Baldus CD, Muller-Tidow C, Bornhauser M, Serve H, Rollig C; Study Alliance Leukemia (SAL). Intensified cytarabine dose during consolidation in adult AML patients under 65 years is not associated with survival benefit: real-world data from the German SAL-AML registry. J Cancer Res Clin Oncol. 2023 Jul;149(8):4611-4621. doi: 10.1007/s00432-022-04356-9. Epub 2022 Sep 28.
PMID: 36167894DERIVEDKunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.
PMID: 36064577DERIVEDRollig C, Kramer M, Schliemann C, Mikesch JH, Steffen B, Kramer A, Noppeney R, Schafer-Eckart K, Krause SW, Hanel M, Herbst R, Kunzmann V, Einsele H, Jost E, Brummendorf TH, Scholl S, Hochhaus A, Neubauer A, Sohlbach K, Fransecky L, Kaufmann M, Niemann D, Schaich M, Frickhofen N, Kiani A, Heits F, Krumpelmann U, Kaiser U, Kullmer J, Wass M, Stolzel F, von Bonin M, Middeke JM, Thiede C, Schetelig J, Berdel WE, Ehninger G, Baldus CD, Muller-Tidow C, Platzbecker U, Serve H, Bornhauser M. Does time from diagnosis to treatment affect the prognosis of patients with newly diagnosed acute myeloid leukemia? Blood. 2020 Aug 13;136(7):823-830. doi: 10.1182/blood.2019004583.
PMID: 32496541DERIVED
Related Links
Biospecimen
bone marrow and peripher blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christoph Röllig, Prof. Dr.
Universitätsklinikum Carl Gustav Carus
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2017
First Posted
June 16, 2017
Study Start
September 1, 2010
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share