Clinical trial NCT04438889: Austrian Myeloid Registry
Official title: Austrian Myeloid Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloid Diseases
Keywords: MDS
CMML
AML
PMF
Austrian Myeloid Registry
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AML, MDS, CMML or PMF according to WHO 2016 diagnostic criteria

Brief summary: The Austrian Myeloid Registry (aMYELOIDr) is a non-interventional study. It collects data from patients with the myeloid diseases, primarily myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML).The aMYELOIDr is multi-center database collecting data at various sites in Austria and potentially also at other centers in other countries in future. The registry has an electronic case report form (eCRF), where all data is entered by clinical trial personnel and/or physicians. It is set up to collect real-world experience in the management of patients with these diseases in Austria.


Eligibility criteria: Inclusion Criteria:

* Age \>17 years
* Diagnosis of myeloid disease according to WHO 2016
* Signed patient informed consent (IC)

Exclusion Criteria:

* Patient is unable or unwilling to sign IC

Primary outcomes:
measure: To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases.
timeFrame: Through study completion, median expected within 100 months
Secondary outcomes:
measure: Impact of front-line treatment on overall survival (OS)
timeFrame: Through study completion, median expected within 100 months
measure: Impact of number and choice of treatment lines on OS as of initial diagnosis and/or as of treatment start
timeFrame: Through study completion, median expected within 100 months
measure: Overall response rate (ORR)
timeFrame: Through study completion, median expected within 100 months
measure: Event free survival (EFS)
timeFrame: Through study completion, median expected within 100 months
measure: AML transformation
timeFrame: Through study completion, median expected within 100 months
measure: Treatment safety
timeFrame: Through study completion, median expected within 100 months
measure: Concomitant treatments
timeFrame: Through study completion, median expected within 100 months
measure: Treatment characteristics
timeFrame: Through study completion, median expected within 100 months
measure: Treatment characteristics
timeFrame: Through study completion, median expected within 100 months
measure: Treatment characteristics
timeFrame: Through study completion, median expected within 100 months
measure: Treatment characteristics
timeFrame: Through study completion, median expected within 100 months
measure: Treatment characteristics
timeFrame: Through study completion, median expected within 100 months
measure: Concomitant treatments best supportive care (BSC)
timeFrame: Through study completion, median expected within 100 months
measure: Quality of life assessment EQ-5D-5L (optional)
timeFrame: Through study completion, median expected within 100 months
measure: EORTC Quality of life assessment QLQ-C30 (optional)
timeFrame: Through study completion, median expected within 100 months
Other outcomes:
measure: Minimal residual disease
timeFrame: Through study completion, median expected within 100 months
measure: MRD-negativity on OS
timeFrame: Through study completion, median expected within 100 months
measure: Prognostic and predictive markers
timeFrame: Through study completion, median expected within 100 months
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie
city: Graz
country: Austria
facility: KH der Barmherzigen Brüder, Innere Medizin I
city: Graz
country: Austria
facility: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Hämatologie
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck, Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie
city: Krems
country: Austria
facility: Universitätsklinikum Krems, Innere Medizin II Hämato-Onkologie
city: Leoben
country: Austria
facility: LKH Hochsteiermark, Abteilung für Hämato-Onkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH, Barmherzige Schwestern, Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Med. III, PMU Salzburg
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten, Klinische Abteilung für Innere Medizin 1
city: Steyr
country: Austria
facility: Klinikum Steyr, Innere Medizin II
city: Vienna
country: Austria
facility: Klinik Donaustadt: 2. Medizinische Abteilung
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
city: Wien
country: Austria
facility: Hanusch KH, 3. Med. Abteilung
city: Wien
country: Austria
facility: Klinik Ottakring, 1. Med. Abteilung
Study officials:
affiliation: AGMT gemeinnützige GmbH
name: Richard Greil, MD
role: STUDY_CHAIR
affiliation: 3rd Med Dept Paracelsus Medical University, Salzburg
name: Lisa Pleyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pleyer L, Leisch M, Kourakli A, Padron E, Maciejewski JP, Xicoy Cirici B, Kaivers J, Ungerstedt J, Heibl S, Patiou P, Hunter AM, Mora E, Geissler K, Dimou M, Jimenez Lorenzo MJ, Melchardt T, Egle A, Viniou AN, Patel BJ, Arnan M, Valent P, Roubakis C, Bernal Del Castillo T, Galanopoulos A, Calabuig Munoz M, Bonadies N, Medina de Almeida A, Cermak J, Jerez A, Montoro MJ, Cortes A, Avendano Pita A, Lopez Andrade B, Hellstroem-Lindberg E, Germing U, Sekeres MA, List AF, Symeonidis A, Sanz GF, Larcher-Senn J, Greil R. Outcomes of patients with chronic myelomonocytic leukaemia treated with non-curative therapies: a retrospective cohort study. Lancet Haematol. 2021 Feb;8(2):e135-e148. doi: 10.1016/S2352-3026(20)30374-4.
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citation: Pleyer L, Vaisband M, Drost M, Pfeilstocker M, Stauder R, Heibl S, Sill H, Girschikofsky M, Stampfl-Mattersberger M, Pichler A, Hartmann B, Petzer A, Schreder M, Schmitt CA, Vallet S, Melchardt T, Zebisch A, Pichler P, Zaborsky N, Machherndl-Spandl S, Wolf D, Keil F, Hasenauer J, Larcher-Senn J, Greil R. Cox proportional hazards deep neural network identifies peripheral blood complete remission to be at least equivalent to morphologic complete remission in predicting outcomes of patients treated with azacitidine-A prospective cohort study by the AGMT. Am J Hematol. 2023 Nov;98(11):1685-1698. doi: 10.1002/ajh.27046. Epub 2023 Aug 7.