Austrian Myeloid Registry

Conditions

Myeloid Diseases

Keywords

MDS, CMML, AML, PMF, Austrian Myeloid Registry

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.

Lisa Pleyer, Xu Zhang, Manuel Drost, Hubert Angermann, Julia Oberlechner et al. (27 authors)

Blood2025-11-03

10.1182/blood-2025-3859

Time-dependent long short-term memory neural cox regression in 2,690 patients with myeloid neoplasias treated with diverse therapies identifies bone marrow related information to be less important than expected in the context of other available clinical parameters: Insights from the AML-001 trial (NCT01074047) and the austrian myeloid registry (NCT04438889) of the AGMT study group

Lisa Pleyer, Xu Zhang, Manuel Drost, Julia Oberlechner, Hubert Angermann et al. (29 authors)

Blood2025-11-03

10.1182/blood-2025-48

Real-World Comparison of Outcomes of Patients Treated with HMA Monotherapy Versus HMA-Ven - Insights from 1634 Patients Included within the Austrian Myeloid Registry of the AGMT Study Group

Lisa Pleyer, Patrick Klammer, Manuel Drost, Hubert Angermann, Felix Keil et al. (25 authors)

Blood2024-11-05

10.1182/blood-2024-207230

Validation of Recent Response Criteria (ELN-22, IWG-23 and PB-CR) in 1634 MDS/CMML/AML Patients Treated with HMA or HMA-Ven Using CPH Models and a CPH Deep Neural Network - Can or Should Response Criteria be Harmonized for Similarly Treated Patients?

Lisa Pleyer, Marc Vaisband, Patrick Klammer, Manuel Drost, Hubert Angermann et al. (31 authors)

Blood2024-11-05

10.1182/blood-2024-208073

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 <scp>AGMT</scp>

Lisa Pleyer, Marc Vaisband, Manuel Drost, Michael Pfeilstöcker, Reinhard Stauder et al. (25 authors)

American Journal of Hematology2023-08-072 citations

10.1002/ajh.27046

Lisa Pleyer, Sonja Heibl, Christoph Tinchon, Sonia Vallet, Martin Schreder et al. (21 authors)

Cancers2023-02-2213 citations

10.3390/cancers15051388

Interventions

OTHERNon-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
AML transformation	Through study completion, median expected within 100 months	Time to transformation to AML for patients with a non-AML initial diagnosis
Concomitant treatments best supportive care (BSC)	Through study completion, median expected within 100 months	Concomitant best supportive care (BSC) measures (e.g. number of transfusions, growth factors, iron chelators)
Quality of life assessment EQ-5D-5L (optional)	Through study completion, median expected within 100 months	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.
EORTC Quality of life assessment QLQ-C30 (optional)	Through study completion, median expected within 100 months	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
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	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.
Event free survival (EFS)	Through study completion, median expected within 100 months	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
Treatment safety	Through study completion, median expected within 100 months	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).
Concomitant treatments	Through study completion, median expected within 100 months	Concomitant treatments (number of administration of e.g. prophylactic antibiotics, antivirals, antifungals)
Treatment characteristics	Through study completion, median expected within 100 months	Among others, the following treatment characteristics will be assessed for each treatment line: substance

Other

Measure	Time frame	Description
Prognostic and predictive markers	Through study completion, median expected within 100 months	Analyses of various factors known or thought to influence OS, ORR, EFS, PFS and time to next treatment in order to validate existing or establish novel prognostic and predictive markers
Minimal residual disease	Through study completion, median expected within 100 months	Assess how many and which patients in Austria have minimal residual disease (MRD) assessments, assessed by which techniques and at which timepoints.
MRD-negativity on OS	Through study completion, median expected within 100 months	Assess the impact of MRD-negativity on OS. MRD assessment via flow-cytometry and polymerase chain reactions according to the current ELN guidelines 2017 shall be exclusively based on the risk/benefit estimation of the treating physician.

Countries

Austria

Contacts

Primary ContactLisa Pleyer, MD

dr.lisa.pleyer@gmail.com+43676899758271

Backup ContactDaniela Wolkersdorfer

office@agmt.at+436626404412

Outcome results

None listed