Clinical trial NCT03188874: Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Official title: Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia (AML)
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly-diagnosed AML, including acute promyelocytic leukemia (APL)

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

Eligibility criteria: 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

Primary outcomes:
measure: Epidemiological parameters
timeFrame: 10 years
measure: Relapse free survival (RFS)
timeFrame: 10 years
measure: Time to relapse (TTR),
timeFrame: 10 years
measure: Overall Survival (OS)
timeFrame: 10 years
measure: cumulative incidence of relapse (CIR)
timeFrame: 10 years
Secondary outcomes:
measure: Complete Remission (CR)
timeFrame: yearly follow up 10 years
measure: Treatment related mortality (TRM)
timeFrame: yearly follow up 10 years
measure: Therapy-associated morbidity
timeFrame: yearly follow up 10 years
measure: Recording and evaluating the quality of therapy and diagnosis
timeFrame: 10 years
measure: Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors
timeFrame: 10 years
measure: Recording and describing new forms of therapy and new supportive measures
timeFrame: 10 years
Other outcomes:
Locations:
city: Baden-Baden
country: Germany
facility: Klinikum Mittelbaden
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Universtitätsklinikum Heidelberg
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH
state: Baden-Württemberg
city: Schwäbisch Hall
country: Germany
facility: Diakonie-Klinikum
state: Baden-Württemberg
city: Sindelfingen
country: Germany
facility: Kliniken Sindelfingen-Böblingen gGmbH
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus GmbH
state: Baden-Württemberg
city: Winnenden
country: Germany
facility: Rems-Murr-Klinikum Winnenden
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
state: Bayern
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg
state: Bayern
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
state: Bayern
city: Coburg
country: Germany
facility: MVZ Klinikum Coburg GmbH
state: Bayern
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus gGmbH
state: Brandenburg
city: Frankfurt an der Oder
country: Germany
facility: Klinikum Frankfurt (Oder) GmbH
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Fulda
country: Germany
facility: Klinikum Fulda / MVZ Osthessen GmbH
state: Hessen
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg
state: Hessen
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Kliniken GmbH
state: Hessen
city: Neubrandenburg
country: Germany
facility: Diakonie Klinikum Dietrich Bonhoeffer
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
state: Mecklenburg-Vorpommern
city: Hildesheim
country: Germany
facility: St. Bernward Krankenhaus Hildesheim
state: Niedersachsen
city: Rotenburg
country: Germany
facility: Agaplesion Diakonieklinikum Rotenburg
state: Niedersachsen
city: Siegen
country: Germany
facility: Marien Kliniken, St. Marien-Krankenhaus
state: Nordhein-Westfalen
city: Düren
country: Germany
facility: Krankenhaus Düren gGmbH
state: Nordrhein Westfalen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: Nordrhein-Westfalen
city: Bielefeld
country: Germany
facility: Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Augusta Kranken Anstalt Bochum
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: Helios Klinikum Duisburg
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Gütersloh
country: Germany
facility: Klinikum Gütersloh
state: Nordrhein-Westfalen
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm GmbH
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Siegen
country: Germany
facility: Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Stiftungsklinikum Mittelrhein GmbH
state: Rheinland-Pfalz
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau
state: Sachsen-Anhalt
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale)
state: Sachsen-Anhalt
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin-Stendal
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
state: Sachsen
city: Riesa
country: Germany
facility: Elblandkliniken Stiftung & Co.KG
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Städtisches Krankenhaus Kiel GmbH
state: Schleswig-Holstein
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
state: Thüringen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Bremen
country: Germany
facility: Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen
Study officials:
affiliation: Universitätsklinikum Carl Gustav Carus
name: Christoph Röllig, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.