Austrian Myeloid Registry

NCT04438889 | Recruiting

• 1 other identifier: AGMT_aMYELOIDr
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 16

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.

Conditions

Myeloid Diseases

Keywords

MDS; CMML; AML; PMF; Austrian Myeloid Registry

Outcome Measures

Primary Outcomes (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.

  Through study completion, median expected within 100 months

Secondary Outcomes (15)

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

  Through study completion, median expected within 100 months

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

  Through study completion, median expected within 100 months

• Overall response rate (ORR)

  Through study completion, median expected within 100 months

• Event free survival (EFS)

  Through study completion, median expected within 100 months

• AML transformation

  Through study completion, median expected within 100 months

Other Outcomes (3)

• Minimal residual disease

  Through study completion, median expected within 100 months

• MRD-negativity on OS

  Through study completion, median expected within 100 months

• Prognostic and predictive markers

  Through study completion, median expected within 100 months

Study Arms (4)

AML

Patients with WHO 2016 diagnosis of AML

Other: Non-interventional

MDS

Patients with WHO 2016 diagnosis of MDS

Other: Non-interventional

CMML

Patients with WHO 2016 diagnosis of CMML

Other: Non-interventional

PMF

Patients with WHO 2016 diagnosis of PMF

Other: Non-interventional

Interventions

Non-interventional OTHER

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.

AML; CMML; MDS; PMF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with AML, MDS, CMML or PMF according to WHO 2016 diagnostic criteria

You may qualify if:

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

You may not qualify if:

• Patient is unable or unwilling to sign IC

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Study Sites (16)

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

Feldkirch, 6807, Austria

RECRUITING

KH der Barmherzigen Brüder, Innere Medizin I

Graz, 8020, Austria

RECRUITING

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

Graz, 8036, Austria

NOT YET RECRUITING

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

Innsbruck, 6020, Austria

RECRUITING

Universitätsklinikum Krems, Innere Medizin II Hämato-Onkologie

Krems, 3500, Austria

RECRUITING

LKH Hochsteiermark, Abteilung für Hämato-Onkologie

Leoben, 8700, Austria

RECRUITING

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

Linz, 4010, Austria

RECRUITING

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

Linz, 4020, Austria

RECRUITING

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

Linz, 4021, Austria

RECRUITING

Universitätsklinik für Innere Med. III, PMU Salzburg

Salzburg, 5020, Austria

RECRUITING

Universitätsklinikum St. Pölten, Klinische Abteilung für Innere Medizin 1

Sankt Pölten, 3100, Austria

RECRUITING

Klinikum Steyr, Innere Medizin II

Steyr, 4400, Austria

RECRUITING

Hanusch KH, 3. Med. Abteilung

Vienna, 1140, Austria

RECRUITING

Klinik Ottakring, 1. Med. Abteilung

Vienna, 1160, Austria

RECRUITING

Klinik Donaustadt: 2. Medizinische Abteilung

Vienna, 1220, Austria

RECRUITING

Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV

Wels, 4600, Austria

RECRUITING

Related Publications (19)

• 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.

  PMID: 28838276 BACKGROUND

• 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.

  PMID: 28535394 BACKGROUND

• 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.

  PMID: 29383443 BACKGROUND

• 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.

  PMID: 28420120 BACKGROUND

• 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.

  PMID: 28212292 BACKGROUND

• 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.

  PMID: 27084507 BACKGROUND

• 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.

  PMID: 25601157 BACKGROUND

• 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.

  PMID: 24951123 BACKGROUND

• 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.

  PMID: 24522248 BACKGROUND

• 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.

  PMID: 24260071 BACKGROUND

• 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.

  PMID: 23627920 BACKGROUND

• 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.

  PMID: 23292646 BACKGROUND

• 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.

  PMID: 21730268 BACKGROUND

• 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.

  PMID: 33513373 BACKGROUND

• 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.

  PMID: 35626063 BACKGROUND

• Pleyer L, Sekeres MA. An early glimpse at azacitidine plus venetoclax for myelodysplastic syndromes. Lancet Haematol. 2022 Oct;9(10):e714-e716. doi: 10.1016/S2352-3026(22)00252-6. Epub 2022 Sep 2. No abstract available.

  PMID: 36063831 BACKGROUND

• Pleyer L, Heibl S, Tinchon C, Vallet S, Schreder M, Melchardt T, Stute N, Fohrenbach Quiroz KT, Leisch M, Egle A, Scagnetti L, Wolf D, Beswick R, Drost M, Larcher-Senn J, Grochtdreis T, Vaisband M, Hasenauer J, Zaborsky N, Greil R, Stauder R. Health-Related Quality of Life as Assessed by the EQ-5D-5L Predicts Outcomes of Patients Treated with Azacitidine-A Prospective Cohort Study by the AGMT. Cancers (Basel). 2023 Feb 22;15(5):1388. doi: 10.3390/cancers15051388.

  PMID: 36900181 BACKGROUND

• Jansko-Gadermeir B, Leisch M, Gassner FJ, Zaborsky N, Dillinger T, Hutter S, Risch A, Melchardt T, Egle A, Drost M, Larcher-Senn J, Greil R, Pleyer L. Myeloid NGS Analyses of Paired Samples from Bone Marrow and Peripheral Blood Yield Concordant Results: A Prospective Cohort Analysis of the AGMT Study Group. Cancers (Basel). 2023 Apr 14;15(8):2305. doi: 10.3390/cancers15082305.

  PMID: 37190237 BACKGROUND

• 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.

  PMID: 37548390 BACKGROUND

Related Links

• Sponsor website

Biospecimen

Retention: SAMPLES WITH DNA

The aMYELOIDr is accompanied by an optional biobanking program. Sample collection will be limited to patients that have signed an additional biobanking IC.

Study Officials

• Richard Greil, MD

  AGMT gemeinnützige GmbH

  STUDY CHAIR

• Lisa Pleyer, MD

  3rd Med Dept Paracelsus Medical University, Salzburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Pleyer, MD

CONTACT

+43676899758271; dr.lisa.pleyer@gmail.com

Daniela Wolkersdorfer

CONTACT

+436626404412; office@agmt.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: June 19, 2020
• Study Start: July 13, 2020
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

AU (16)