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

NCT ID: NCT03188874

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2030-09-30

Brief Summary

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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

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see brief summary

Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Röllig, Prof. Dr.

Role: STUDY_DIRECTOR

Universitätsklinikum Carl Gustav Carus

Locations

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Klinikum Mittelbaden

Baden-Baden, Baden-Wurttemberg, Germany

Site Status RECRUITING

Universtitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Klinikum Mannheim GmbH

Mannheim, Baden-Wurttemberg, Germany

Site Status RECRUITING

Diakonie-Klinikum

Schwäbisch Hall, Baden-Wurttemberg, Germany

Site Status RECRUITING

Kliniken Sindelfingen-Böblingen gGmbH

Sindelfingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Robert-Bosch-Krankenhaus GmbH

Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING

Rems-Murr-Klinikum Winnenden

Winnenden, Baden-Wurttemberg, Germany

Site Status RECRUITING

Klinikum Augsburg

Augsburg, Bavaria, Germany

Site Status RECRUITING

Sozialstiftung Bamberg

Bamberg, Bavaria, Germany

Site Status RECRUITING

Klinikum Bayreuth GmbH

Bayreuth, Bavaria, Germany

Site Status RECRUITING

MVZ Klinikum Coburg GmbH

Coburg, Bavaria, Germany

Site Status RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status RECRUITING

Klinikum Nürnberg

Nuremberg, Bavaria, Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Site Status RECRUITING

Carl-Thiem-Klinikum Cottbus gGmbH

Cottbus, Brandenburg, Germany

Site Status RECRUITING

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), Brandenburg, Germany

Site Status RECRUITING

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Klinikum Fulda / MVZ Osthessen GmbH

Fulda, Hesse, Germany

Site Status RECRUITING

Universitätsklinikum Gießen und Marburg

Marburg, Hesse, Germany

Site Status RECRUITING

Dr. Horst Schmidt Kliniken GmbH

Wiesbaden, Hesse, Germany

Site Status RECRUITING

St. Bernward Krankenhaus Hildesheim

Hildesheim, Lower Saxony, Germany

Site Status RECRUITING

Agaplesion Diakonieklinikum Rotenburg

Rotenburg (Wümme), Lower Saxony, Germany

Site Status RECRUITING

Diakonie Klinikum Dietrich Bonhoeffer

Neubrandenburg, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Klinikum Südstadt Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Marien Kliniken, St. Marien-Krankenhaus

Siegen, Nordhein-Westfalen, Germany

Site Status RECRUITING

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte

Bielefeld, North Rhine-Westphalia, Germany

Site Status RECRUITING

Augusta Kranken Anstalt Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Helios Klinikum Duisburg

Duisburg, North Rhine-Westphalia, Germany

Site Status RECRUITING

Krankenhaus Düren gGmbH

Düren, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Klinikum Gütersloh

Gütersloh, North Rhine-Westphalia, Germany

Site Status RECRUITING

St. Barbara-Klinik Hamm GmbH

Hamm, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus

Siegen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Stiftungsklinikum Mittelrhein GmbH

Koblenz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Site Status RECRUITING

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Site Status RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Site Status RECRUITING

Klinikum St. Georg gGmbH

Leipzig, Saxony, Germany

Site Status RECRUITING

Elblandkliniken Stiftung & Co.KG

Riesa, Saxony, Germany

Site Status RECRUITING

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Universitätsklinikum Halle (Saale)

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Johanniter-Krankenhaus Genthin-Stendal

Stendal, Saxony-Anhalt, Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Städtisches Krankenhaus Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Klinikum Altenburger Land GmbH

Altenburg, Thuringia, Germany

Site Status RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, Germany

Site Status RECRUITING

Helios Klinikum Berlin-Buch

Berlin, , Germany

Site Status RECRUITING

Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen

Bremen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christoph Röllig, Prof. Dr.

Role: CONTACT

Facility Contacts

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Kai Neben, Prof.

Role: primary

Carsten Müller-Tidow, Prof.

Role: primary

Stefan Klein, PD Dr.

Role: primary

Thomas Geer, Dr.

Role: primary

Markus Ritter, PD Dr.

Role: primary

Martin Kaufmann, Dr.

Role: primary

Markus Schaich, Prof.

Role: primary

Andreas Rank, PD Dr.

Role: primary

Ruth Seggewiß-Bernhard, PD Dr.

Role: primary

Alexander Kiani, Prof.

Role: primary

Christof Lamberti, PD. Dr.

Role: primary

Stefan Krause, Prof.

Role: primary

Kerstin Schäfer-Eckart, Dr.

Role: primary

Hermann Einsele, Prof.

Role: primary

Martin Schmidt-Hieber, PD Dr.

Role: primary

Michael Kiehl, Prof.

Role: primary

Hubert Serve, Prof.

Role: primary

Heinz-Gert Höffkes, Prof.

Role: primary

Andreas Neubauer, Prof.

Role: primary

Natalia Heinz, Dr.

Role: primary

Ulrich Kaiser, Prof.

Role: primary

Achim Meinhardt, Dr.

Role: primary

Philipp Hemmati, PD Dr.

Role: primary

Beate Krammer-Steiner, Dr.

Role: primary

Winfried Gassmann, Prof. Dr.

Role: primary

Tim H. Brümmendorf, Prof.

Role: primary

Martin Görner, PD Dr.

Role: primary

Dirk Behringer, Prof.

Role: primary

Götz Ulrich Grigoleit, PD Dr.

Role: primary

Michael Flaßhove, PD Dr.

Role: primary

Paul Jäger, Dr.

Role: primary

Maher Hanoun, Dr.

Role: primary

Gero Massenkeil, Prof.

Role: primary

Heinz Dürk, Dr.

Role: primary

Wolfgang Berdel, Prof.

Role: primary

Ralph Naumann, Prof. Dr.

Role: primary

Martin Klump, Dr.

Role: backup

Dirk Niemann, Dr.

Role: primary

Mathias Hänel, PD Dr.

Role: primary

Christoph Röllig, Prof.

Role: primary

Madlen Jentzsch, PD Dr.

Role: primary

Luisa Mantovani-Löffler, Dr.

Role: primary

Jörg Schubert, Prof.

Role: primary

Wolfgang Schütte, Prof.

Role: primary

Lutz Peter Müller, Prof.

Role: primary

Martin Mohren, PD Dr.

Role: primary

Claudia Baldus, Prof.

Role: primary

Roland Repp, Prof.

Role: primary

Romy Pomper, Dr.

Role: primary

Andreas Hochhaus, Prof.

Role: primary

Bertram Glaß, Prof.

Role: primary

Ulrich Trappe, Prof. Dr.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36167894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36064577 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32496541 (View on PubMed)

Related Links

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Other Identifiers

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SAL-AML-REG-BIO

Identifier Type: -

Identifier Source: org_study_id

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