AzTrials
AzTrials

Myeloid DiseasesaMYELOIDrNCT04438889

Austrian Myeloid Registry

An observational study of Myeloid Diseases, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 16 sites in Austria.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloid Diseases
What is being tested?
Non-interventional
How many people
3,000 participants
Where
16 sitesAustria
Study dates
13 Jul 2020to Apr 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 AML, MDS, CMML or PMF according to WHO 2016 diagnostic criteria

Who may be able to join

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

Who cannot join

  • Patient is unable or unwilling to sign IC

Trial locations and contacts

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

Lisa Pleyer, MD contact

+43676899758271

dr.lisa.pleyer@gmail.com

Daniela Wolkersdorfer contact

+436626404412

office@agmt.at

16 sites in 1 country

Austria16 sites, 16 recruiting

  • LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie

    Feldkirch, 6807

    Bernd Hartmann, MD

    Recruiting

  • KH der Barmherzigen Brüder, Innere Medizin I

    Graz, 8020

    Andrea Hammerl-Steiner, MD

    Recruiting

  • Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Hämatologie

    Graz, 8036

    Armin Zebisch, MD

    Not yet recruiting

  • Universitätsklinik Innsbruck, Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie

    Innsbruck, 6020

    Dominik Wolf, MD

    Recruiting

  • Universitätsklinikum Krems, Innere Medizin II Hämato-Onkologie

    Krems, 3500

    Martin Pecherstorfer, MD

    Recruiting

  • LKH Hochsteiermark, Abteilung für Hämato-Onkologie

    Leoben, 8700

    Angelika Pichler, MD

    Recruiting

  • Ordensklinikum Linz GmbH, Barmherzige Schwestern, Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie

    Linz, 4010

    Gregor Aschauer, MD

    Recruiting

  • Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie

    Linz, 4020

    Sigrid Machherndl-Spandl, MD

    Recruiting

  • Kepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie

    Linz, 4021

    Clemens Schmitt, MD

    Recruiting

  • Universitätsklinik für Innere Med. III, PMU Salzburg

    Salzburg, 5020

    Lisa Pleyer, MD

    Recruiting

  • Universitätsklinikum St. Pölten, Klinische Abteilung für Innere Medizin 1

    Sankt Pölten, 3100

    Petra Pichler, MD

    Recruiting

  • Klinikum Steyr, Innere Medizin II

    Steyr, 4400

    Johannes Andel, MD

    Recruiting

  • Hanusch KH, 3. Med. Abteilung

    Vienna, 1140

    Felix Keil, MD

    Recruiting

  • Klinik Ottakring, 1. Med. Abteilung

    Vienna, 1160

    Martin Schreder, MD

    Recruiting

  • Klinik Donaustadt: 2. Medizinische Abteilung

    Vienna, 1220

    Margarete Stampfl-Mattersberger, MD

    Recruiting

  • Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV

    Wels, 4600

    Sonja Heibl, MD

    Recruiting

Other trials in Austria

About this study

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.

Being tested
Non-interventional
Keywords
MDS, CMML, AML, PMF, Austrian Myeloid Registry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-interventionalOther

    Only routine clinical data, which has already been recorded in the patient's medical chart, will be documented. Any other data assessments (e.g. quality of life analyses such as EQ-5D and QLQ-C30 have been approved by the Ehtikkommission für das Bundesland Salzburg and are optional.

Study groups in NCT04438889
Study groupRoleWhat they receive
AMLPatients with WHO 2016 diagnosis of AML
Receives: Other: Non-interventional
MDSPatients with WHO 2016 diagnosis of MDS
Receives: Other: Non-interventional
CMMLPatients with WHO 2016 diagnosis of CMML
Receives: Other: Non-interventional
PMFPatients with WHO 2016 diagnosis of PMF
Receives: Other: Non-interventional

What is being measured

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

  1. To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases.

    Due to the non-interventional nature of the aMYELOIDr, treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations shall be exclusively based on the risk/benefit estimation of the treating physician. We recommend compliance current guidelines.

    Measured: Through study completion, median expected within 100 months

Secondary outcomes (15)

  1. Impact of front-line treatment on overall survival (OS)

    Measured: Through study completion, median expected within 100 months

  2. Impact of number and choice of treatment lines on OS as of initial diagnosis and/or as of treatment start

    Measured: Through study completion, median expected within 100 months

  3. Overall response rate (ORR)

    Response will be assessed according to current guidelines for the respective disease. Due to the non-interventional nature of the aMYELOIDr, timepoints and types of response assessment shall be exclusively based on the risk/benefit estimation of the treating physician. We recommend compliance current guidelines.

    Measured: Through study completion, median expected within 100 months

  4. Event free survival (EFS)

    Events include treatment failure, progressive disease, relapse after CR/CRi, death from any cause. Patients lost to-follow-up or still alive ans without event will be censored at last follow-up date

    Measured: Through study completion, median expected within 100 months

  5. AML transformation

    Time to transformation to AML for patients with a non-AML initial diagnosis

    Measured: Through study completion, median expected within 100 months

  6. Treatment safety

    Investigators should report adverse reactions (for which a causal role of a medicine is suspected) to the concerned competent authorities following regulations in the current or future versions of Austrian legislation (Pharmakovigilanz-Verordnung 2013 (PhVO, Regulation on Pharmacovigilance), Österreichisches Arzneimittel Gesetz (AMG, Austrian Medicinal Products Act). Participation in this registry does not exempt the participating center from their legal reporting obligations. Documentation of causality, duration, frequency and severity of adverse events (AEs) according to Common Terminology Criteria for AE (CTCAE v.5).

    Measured: Through study completion, median expected within 100 months

  7. Concomitant treatments

    Concomitant treatments (number of administration of e.g. prophylactic antibiotics, antivirals, antifungals)

    Measured: Through study completion, median expected within 100 months

  8. Treatment characteristics

    Among others, the following treatment characteristics will be assessed for each treatment line: substance

    Measured: Through study completion, median expected within 100 months

  9. Treatment characteristics

    Among others, the following treatment characteristics will be assessed for each treatment line: application date

    Measured: Through study completion, median expected within 100 months

  10. Treatment characteristics

    Among others, the following treatment characteristics will be assessed for each treatment line: route

    Measured: Through study completion, median expected within 100 months

  11. Treatment characteristics

    Among others, the following treatment characteristics will be assessed for each treatment line: dose

    Measured: Through study completion, median expected within 100 months

  12. Treatment characteristics

    Among others, the following treatment characteristics will be assessed for each treatment line: inpatient or outpatient setting

    Measured: Through study completion, median expected within 100 months

  13. Concomitant treatments best supportive care (BSC)

    Concomitant best supportive care (BSC) measures (e.g. number of transfusions, growth factors, iron chelators)

    Measured: Through study completion, median expected within 100 months

  14. Quality of life assessment EQ-5D-5L (optional)

    EuroQol-5 Dimensions with 5 Levels. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.

    Measured: Through study completion, median expected within 100 months

  15. EORTC Quality of life assessment QLQ-C30 (optional)

    European Organisation for Research and Treatment of Cancer Quality of life 30-item questionnaire of cancer patients incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation anddiarrhoea) and perceived financial impact of the disease. It has four-point scale which are coded with "Not at all", "A little", "Quite a bit" and "Very much"

    Measured: Through study completion, median expected within 100 months

Timeline

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

  1. First posted19 Jun 2020
  2. Study start13 Jul 2020
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 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
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04438889
Sponsor's protocol ID
AGMT_aMYELOIDr
Acronym
aMYELOIDr
Status last verified
Apr 2025
First submitted
24 Feb 2020
Last updated
10 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Falantes J, Pleyer L, Thepot S, Almeida AM, Maurillo L, Martinez-Robles V, Stauder R, Itzykson R, Pinto R, Venditti A, Bargay J, Burgstaller S, Martinez MP, Seegers V, Cortesao E, Foncillas MA, Gardin C, Montesinos P, Musto P, Fenaux P, Greil R, Sanz MA, Ramos F; European ALMA + Investigators. Real life experience with frontline azacitidine in a large series of older adults with acute myeloid leukemia stratified by MRC/LRF score: results from the expanded international E-ALMA series (E-ALMA+). Leuk Lymphoma. 2018 May;59(5):1113-1120. doi: 10.1080/10428194.2017.1365854. Epub 2017 Aug 24.

    PubMed 28838276

  • Leisch M, Weiss L, Lindlbauer N, Jungbauer C, Egle A, Rohde E, Greil R, Grabmer C, Pleyer L. Red blood cell alloimmunization in 184 patients with myeloid neoplasms treated with azacitidine - A retrospective single center experience. Leuk Res. 2017 Aug;59:12-19. doi: 10.1016/j.leukres.2017.05.006. Epub 2017 May 9.

    PubMed 28535394

  • Huemer F, Weiss L, Faber V, Neureiter D, Egle A, Geissler K, Voskova D, Zebisch A, Burgstaller S, Pichler A, Stauder R, Sperr W, Lang A, Pfeilstocker M, Machherndl-Spandl S, Stampfl M, Greil R, Pleyer L. Establishment and validation of a novel risk model for estimating time to first treatment in 120 patients with chronic myelomonocytic leukaemia. Wien Klin Wochenschr. 2018 Feb;130(3-4):115-125. doi: 10.1007/s00508-018-1315-2. Epub 2018 Jan 30.

    PubMed 29383443

  • Almeida AM, Prebet T, Itzykson R, Ramos F, Al-Ali H, Shammo J, Pinto R, Maurillo L, Wetzel J, Musto P, Van De Loosdrecht AA, Costa MJ, Esteves S, Burgstaller S, Stauder R, Autzinger EM, Lang A, Krippl P, Geissler D, Falantes JF, Pedro C, Bargay J, Deben G, Garrido A, Bonanad S, Diez-Campelo M, Thepot S, Ades L, Sperr WR, Valent P, Fenaux P, Sekeres MA, Greil R, Pleyer L. Clinical Outcomes of 217 Patients with Acute Erythroleukemia According to Treatment Type and Line: A Retrospective Multinational Study. Int J Mol Sci. 2017 Apr 14;18(4):837. doi: 10.3390/ijms18040837.

    PubMed 28420120

  • Pleyer L, Dohner H, Dombret H, Seymour JF, Schuh AC, Beach CL, Swern AS, Burgstaller S, Stauder R, Girschikofsky M, Sill H, Schlick K, Thaler J, Halter B, Machherndl Spandl S, Zebisch A, Pichler A, Pfeilstocker M, Autzinger EM, Lang A, Geissler K, Voskova D, Sperr WR, Hojas S, Rogulj IM, Andel J, Greil R. Azacitidine for Front-Line Therapy of Patients with AML: Reproducible Efficacy Established by Direct Comparison of International Phase 3 Trial Data with Registry Data from the Austrian Azacitidine Registry of the AGMT Study Group. Int J Mol Sci. 2017 Feb 15;18(2):415. doi: 10.3390/ijms18020415.

    PubMed 28212292

  • Pleyer L, Burgstaller S, Stauder R, Girschikofsky M, Sill H, Schlick K, Thaler J, Halter B, Machherndl-Spandl S, Zebisch A, Pichler A, Pfeilstocker M, Autzinger EM, Lang A, Geissler K, Voskova D, Geissler D, Sperr WR, Hojas S, Rogulj IM, Andel J, Greil R. Azacitidine front-line in 339 patients with myelodysplastic syndromes and acute myeloid leukaemia: comparison of French-American-British and World Health Organization classifications. J Hematol Oncol. 2016 Apr 16;9:39. doi: 10.1186/s13045-016-0263-4.

    PubMed 27084507

  • Ramos F, Thepot S, Pleyer L, Maurillo L, Itzykson R, Bargay J, Stauder R, Venditti A, Seegers V, Martinez-Robles V, Burgstaller S, Recher C, Deben G, Gaidano G, Gardin C, Musto P, Greil R, Sanchez-Guijo F, Fenaux P; European ALMA Investigators. Azacitidine frontline therapy for unfit acute myeloid leukemia patients: clinical use and outcome prediction. Leuk Res. 2015 Mar;39(3):296-306. doi: 10.1016/j.leukres.2014.12.013. Epub 2014 Dec 31.

    PubMed 25601157

  • Pleyer L, Burgstaller S, Girschikofsky M, Linkesch W, Stauder R, Pfeilstocker M, Schreder M, Tinchon C, Sliwa T, Lang A, Sperr WR, Krippl P, Geissler D, Voskova D, Schlick K, Thaler J, Machherndl-Spandl S, Theiler G, Eckmullner O, Greil R. Azacitidine in 302 patients with WHO-defined acute myeloid leukemia: results from the Austrian Azacitidine Registry of the AGMT-Study Group. Ann Hematol. 2014 Nov;93(11):1825-38. doi: 10.1007/s00277-014-2126-9. Epub 2014 Jun 21.

    PubMed 24951123

  • Pleyer L, Germing U, Sperr WR, Linkesch W, Burgstaller S, Stauder R, Girschikofsky M, Schreder M, Pfeilstocker M, Lang A, Sliwa T, Geissler D, Schlick K, Placher-Sorko G, Theiler G, Thaler J, Mitrovic M, Neureiter D, Valent P, Greil R. Azacitidine in CMML: matched-pair analyses of daily-life patients reveal modest effects on clinical course and survival. Leuk Res. 2014 Apr;38(4):475-83. doi: 10.1016/j.leukres.2014.01.006. Epub 2014 Jan 18.

    PubMed 24522248

  • Melchardt T, Weiss L, Pleyer L, Steinkirchner S, Auberger J, Hopfinger G, Greil R, Egle A. Complications of 5-azacytidine: Three cases of severe ischemic colitis in elderly patients with myelodysplastic syndrome. Oncol Lett. 2013 Dec;6(6):1756-1758. doi: 10.3892/ol.2013.1629. Epub 2013 Oct 15.

    PubMed 24260071

  • Pleyer L, Stauder R, Burgstaller S, Schreder M, Tinchon C, Pfeilstocker M, Steinkirchner S, Melchardt T, Mitrovic M, Girschikofsky M, Lang A, Krippl P, Sliwa T, Egle A, Linkesch W, Voskova D, Angermann H, Greil R. Azacitidine in patients with WHO-defined AML - results of 155 patients from the Austrian Azacitidine Registry of the AGMT-Study Group. J Hematol Oncol. 2013 Apr 29;6:32. doi: 10.1186/1756-8722-6-32.

    PubMed 23627920

  • Valentiny C, Mitrovic M, Pleyer L, Steurer M, Willenbacher W, Stauder R. Complete remission after a single cycle of azacitidine in a case of relapsed acute myeloid leukemia. Wien Klin Wochenschr. 2013 Jan;125(1-2):50-3. doi: 10.1007/s00508-012-0319-6. Epub 2013 Jan 5.

    PubMed 23292646

  • Weiss L, Melchardt T, Neureiter D, Kemmerling R, Moshir S, Pleyer L, Greil R, Egle A. Complete remission of Waldenstrom macroglobulinemia with azacitidine and rituximab. J Clin Oncol. 2011 Aug 20;29(24):e696-8. doi: 10.1200/JCO.2011.35.8283. Epub 2011 Jul 5. No abstract available.

    PubMed 21730268

  • 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.

    PubMed 33513373

  • Leisch M, Pfeilstocker M, Stauder R, Heibl S, Sill H, Girschikofsky M, Stampfl-Mattersberger M, Tinchon C, Hartmann B, Petzer A, Schreder M, Kiesl D, Vallet S, Egle A, Melchardt T, Piringer G, Zebisch A, Machherndl-Spandl S, Wolf D, Keil F, Drost M, Greil R, Pleyer L. Adverse Events in 1406 Patients Receiving 13,780 Cycles of Azacitidine within the Austrian Registry of Hypomethylating Agents-A Prospective Cohort Study of the AGMT Study-Group. Cancers (Basel). 2022 May 17;14(10):2459. doi: 10.3390/cancers14102459.

    PubMed 35626063

Questions about this trial

What is this clinical trial studying?

An observational study of Myeloid Diseases, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 16 sites in Austria.

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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Austria. 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 Lisa Pleyer, MD (+43676899758271, dr.lisa.pleyer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases. (time frame: Through study completion, median expected within 100 months). 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 NCT04438889, which also lists 19 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 10 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in