AzTrials
AzTrials

Acute Myeloid Leukemia (AML)NCT03188874

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

An observational study of Acute Myeloid Leukemia (AML), run by Technische Universität Dresden at 60 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML)
How many people
15,000 participants
Where
60 sitesGermany
Study dates
Sep 2010to 30 Sep 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • there are no exclusion criteria

Trial locations and contacts

60 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christoph Röllig, Prof. Dr. contact

christoph.roellig@uniklinikum-dresden.de

60 sites in 1 country

Germany60 sites, 60 recruiting

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

    Tim H. Brümmendorf, Prof.

    Recruiting

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 04600

    Christina Klötzer, Dr. med.

    Recruiting

  • Klinikum Augsburg

    Augsburg, Bavaria, 86156

    Andreas Rank, PD Dr.

    Recruiting

  • Klinikum Mittelbaden

    Baden-Baden, Baden-Wurttemberg, 76532

    Kai Neben, Prof.

    Recruiting

  • Sozialstiftung Bamberg

    Bamberg, Bavaria, 96049

    Alexander Porst

    Recruiting

  • Klinikum Bayreuth GmbH

    Bayreuth, Bavaria, 95445

    Alexander Kiani, Prof.

    Recruiting

  • Alexianer St. Hedwig-Krankenhaus

    Berlin, State of Berlin, 10115

    Alexander Kühnemund, Dr. med.

    Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin, State of Berlin, 13125

    Bertram Glaß, Prof.

    Recruiting

  • Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte

    Bielefeld, North Rhine-Westphalia, 33604

    Martin Görner, PD Dr.

    Recruiting

  • Augusta Kranken Anstalt Bochum

    Bochum, North Rhine-Westphalia, 44791

    Dirk Behringer, Prof.

    Recruiting

  • Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen

    Bremen, 28239

    Michael Heinsch, Dr. med.

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09113

    Mathias Hänel, PD Dr.

    Recruiting

  • MVZ Klinikum Coburg GmbH

    Coburg, Bavaria, 96450

    Christof Lamberti, PD. Dr.

    Recruiting

  • Klinikum der Universität zu Köln

    Cologne, North Rhine-Westphalia, 50937

    Lukas Frenzel, PD Dr. med.

    Recruiting

  • Carl-Thiem-Klinikum Cottbus gGmbH

    Cottbus, Brandenburg, 03048

    Martin Schmidt-Hieber, PD Dr.

    Recruiting

  • ONKO Medeor Onkologische Zentren

    Donauwörth, Bavaria, 86609

    Dirk Hempel, Prof. Dr. med.

    Recruiting

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

    Christoph Röllig, Prof.

    Recruiting

  • Helios Klinikum Duisburg

    Duisburg, North Rhine-Westphalia, 47166

    Sebastian Balleisen, Dr. med.

    Recruiting

  • Helios Klinikum Duisburg

    Duisburg, North Rhine-Westphalia, 47228

    Stela Theodoropulou, Dr.

    Recruiting

  • Krankenhaus Düren gGmbH

    Düren, North Rhine-Westphalia, 52351

    Michael Flaßhove, PD Dr.

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

    Paul Jäger, Dr.

    Recruiting

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, 99089

    Sebastian Scholl, Prof. Dr. med.

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

    Heidi Waibel, Dr.

    Recruiting

  • Alfried Krupp Krankenhaus Rüttenscheid

    Essen, North Rhine-Westphalia, 45131

    Burkhard Hennemann, Prof. Dr. med.

    Recruiting

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45747

    Christina Rautenberg, Dr.

    Recruiting

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), Brandenburg, 15236

    Michael Kiehl, Prof.

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

    Björn Steffen, Dr.

    Recruiting

  • Klinikum Fulda / MVZ Osthessen GmbH

    Fulda, Hesse, 36043

    Heinz-Gert Höffkes, Prof.

    Recruiting

  • Klinikum Gütersloh

    Gütersloh, North Rhine-Westphalia, 33332

    Gero Massenkeil, Prof.

    Recruiting

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, Saxony-Anhalt, 06120

    Ulrike Nitschke

    Recruiting

  • Universitätsklinikum Halle (Saale)

    Halle, Saxony-Anhalt, 06120

    Thomas Weber, PD Dr.

    Recruiting

  • St. Barbara-Klinik Hamm GmbH

    Hamm, North Rhine-Westphalia, 59075

    Heinz Dürk, Dr.

    Recruiting

  • Universtitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Tim Sauer, Dr. med.

    Recruiting

  • St. Bernward Krankenhaus Hildesheim

    Hildesheim, Lower Saxony, 31134

    Christian Könecke, Prof.

    Recruiting

  • Universitätsklinikum Jena

    Jena, Thuringia, 07740

    Ulf Schnetzke, PD Dr.

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

    Lars Fransecky, Dr.

    Recruiting

  • Städtisches Krankenhaus Kiel GmbH

    Kiel, Schleswig-Holstein, 24116

    Roland Repp, Prof.

    Recruiting

  • Stiftungsklinikum Mittelrhein GmbH

    Koblenz, Rhineland-Palatinate, 56068

    Dirk Niemann, Dr.

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

    Madlen Jentzsch, PD Dr.

    Recruiting

  • Klinikum St. Georg gGmbH

    Leipzig, Saxony, 04129

    Henning Blasberg

    Recruiting

  • Klinikum Mannheim GmbH

    Mannheim, Baden-Wurttemberg, 68167

    Stefan Klein, PD Dr.

    Recruiting

  • Universitätsklinikum Gießen und Marburg

    Marburg, Hesse, 35033

    Andreas Neubauer, Prof.

    Recruiting

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

    Christoph Schliemann, Prof. Dr. med.

    Recruiting

  • Diakonie Klinikum Dietrich Bonhoeffer

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

    Philipp Hemmati, PD Dr.

    Recruiting

  • Klinikum Nürnberg

    Nuremberg, Bavaria, 90419

    Kerstin Schäfer-Eckart, Dr.

    Recruiting

  • Elblandkliniken Stiftung & Co.KG

    Riesa, Saxony, 01589

    Jörg Schubert, Prof.

    Recruiting

  • Klinikum Südstadt Rostock

    Rostock, Mecklenburg-Vorpommern, 18059

    Beate Krammer-Steiner, Dr.

    Recruiting

  • Agaplesion Diakonieklinikum Rotenburg

    Rotenburg (Wümme), Lower Saxony, 27956

    Achim Meinhardt, Dr.

    Recruiting

  • Diakonie-Klinikum

    Schwäbisch Hall, Baden-Wurttemberg, 74523

    Thomas Geer, Dr.

    Recruiting

  • HELIOS Klinikum Schwerin

    Schwerin, Mecklenburg-Vorpommern, 10955

    Recruiting

  • Marien Kliniken, St. Marien-Krankenhaus

    Siegen, Nordhein-Westfalen, 57072

    Elisabeth Mack, PD Dr.

    Recruiting

  • Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus

    Siegen, North Rhine-Westphalia, 57074

    Ralph Naumann, Prof. Dr.

    Martin Klump, Dr.

    Recruiting

  • Kliniken Sindelfingen-Böblingen gGmbH

    Sindelfingen, Baden-Wurttemberg, 71065

    Fabian Klaus, Dr.

    Recruiting

  • Johanniter-Krankenhaus Genthin-Stendal

    Stendal, Saxony-Anhalt, 39576

    Lars Thiele, Dr. med.

    Recruiting

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, Baden-Wurttemberg, 70376

    Martin Kaufmann, Dr.

    Recruiting

  • Dr. Horst Schmidt Kliniken GmbH

    Wiesbaden, Hesse, 65199

    Natalia Heinz, Dr.

    Recruiting

  • Rems-Murr-Klinikum Winnenden

    Winnenden, Baden-Wurttemberg, 71364

    Markus Schaich, Prof.

    Recruiting

  • Klinikum Wolfsburg

    Wolfsburg, Lower Saxony, 38440

    Steffen Neumann, Dr. med.

    Recruiting

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

    Volker Kunzmann, Prof.

    Recruiting

  • Heinrich-Braun-Klinikum gGmbH

    Zwickau, Saxony, 08060

    Sara Hilber, Dr.

    Recruiting

Other trials in Germany

About this study

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
Read the detailed description

see brief summary

Medical subject headings
Leukemia, Myeloid, Acute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epidemiological parameters

    Epidemiological parameters

    Measured: 10 years

  2. Relapse free survival (RFS)

    Relapse free survival

    Measured: 10 years

  3. Time to relapse (TTR),

    Time to relapse (TTR),

    Measured: 10 years

  4. Overall Survival (OS)

    Overall Survival (OS)

    Measured: 10 years

  5. cumulative incidence of relapse (CIR)

    cumulative incidence of relapse (CIR)

    Measured: 10 years

Secondary outcomes (6)

  1. Complete Remission (CR)

    Complete Remission

    Measured: yearly follow up 10 years

  2. Treatment related mortality (TRM)

    Treatment related mortality

    Measured: yearly follow up 10 years

  3. Therapy-associated morbidity

    grade IV toxicities

    Measured: yearly follow up 10 years

  4. Recording and evaluating the quality of therapy and diagnosis

    Recording and evaluating the quality of therapy and diagnosis

    Measured: 10 years

  5. 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

    Measured: 10 years

  6. Recording and describing new forms of therapy and new supportive measures

    Recording and describing new forms of therapy and new supportive measures

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study startSep 2010
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
15,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03188874
Sponsor's protocol ID
SAL-AML-REG-BIO
Status last verified
Apr 2026
First submitted
1 Mar 2017
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36167894

  • Kunadt 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.

    PubMed 36064577

  • Rollig 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.

    PubMed 32496541

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia (AML), run by Technische Universität Dresden at 60 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christoph Röllig, Prof. Dr. (christoph.roellig@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epidemiological parameters (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03188874, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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