Austrian Myeloid Registry

Overview

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.

Interventions

• Other Non-interventional
  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.

Primary outcome measures

• To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases. [Time frame: Through study completion, median expected within 100 months]

Secondary outcome measures (12)

• Impact of front-line treatment on overall survival (OS) [Time frame: 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 [Time frame: Through study completion, median expected within 100 months]
• Overall response rate (ORR) [Time frame: Through study completion, median expected within 100 months]
• Event free survival (EFS) [Time frame: Through study completion, median expected within 100 months]
• AML transformation [Time frame: Through study completion, median expected within 100 months]
• Treatment safety [Time frame: Through study completion, median expected within 100 months]
• Concomitant treatments [Time frame: Through study completion, median expected within 100 months]
• Treatment characteristics [Time frame: Through study completion, median expected within 100 months]
• Treatment characteristics [Time frame: Through study completion, median expected within 100 months]
• Treatment characteristics [Time frame: Through study completion, median expected within 100 months]
• Treatment characteristics [Time frame: Through study completion, median expected within 100 months]
• Treatment characteristics [Time frame: Through study completion, median expected within 100 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Austria · 16 centers

• LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie — Feldkirch
• KH der Barmherzigen Brüder, Innere Medizin I — Graz
• Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung — Graz
• Universitätsklinik Innsbruck, Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie — Innsbruck
• Universitätsklinikum Krems, Innere Medizin II Hämato-Onkologie — Krems
• LKH Hochsteiermark, Abteilung für Hämato-Onkologie — Leoben
• Ordensklinikum Linz GmbH, Barmherzige Schwestern, Interne I: Internistische Onkologie, Häm — Linz
• Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie — Linz
• … and 8 more centers

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 leuk PMID 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. PMID 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. do PMID 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 P PMID 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 PMID 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 Wor PMID 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: 10.101 PMID 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 N PMID 24951123

Identifiers

NCT: NCT04438889 · AGMT_aMYELOIDr

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗