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.
Study Type
OBSERVATIONAL
Enrollment
3,000
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.
LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie
Feldkirch, Austria
RECRUITINGKH der Barmherzigen Brüder, Innere Medizin I
Graz, Austria
RECRUITINGMedizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Hämatologie
Graz, Austria
NOT_YET_RECRUITINGUniversitätsklinik Innsbruck, Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie
Innsbruck, Austria
RECRUITINGUniversitätsklinikum Krems, Innere Medizin II Hämato-Onkologie
Krems, Austria
RECRUITINGLKH Hochsteiermark, Abteilung für Hämato-Onkologie
Leoben, Austria
RECRUITINGOrdensklinikum Linz GmbH, Barmherzige Schwestern, Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie
Linz, Austria
RECRUITINGOrdensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
Linz, Austria
RECRUITINGKepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie
Linz, Austria
RECRUITINGUniversitätsklinik für Innere Med. III, PMU Salzburg
Salzburg, Austria
RECRUITING...and 6 more locations
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.
Time frame: Through study completion, median expected within 100 months
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)
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.
Time frame: Through study completion, median expected within 100 months
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
Time frame: Through study completion, median expected within 100 months
AML transformation
Time to transformation to AML for patients with a non-AML initial diagnosis
Time frame: Through study completion, median expected within 100 months
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).
Time frame: Through study completion, median expected within 100 months
Concomitant treatments
Concomitant treatments (number of administration of e.g. prophylactic antibiotics, antivirals, antifungals)
Time frame: Through study completion, median expected within 100 months
Treatment characteristics
Among others, the following treatment characteristics will be assessed for each treatment line: substance
Time frame: Through study completion, median expected within 100 months
Treatment characteristics
Among others, the following treatment characteristics will be assessed for each treatment line: application date
Time frame: Through study completion, median expected within 100 months
Treatment characteristics
Among others, the following treatment characteristics will be assessed for each treatment line: route
Time frame: Through study completion, median expected within 100 months
Treatment characteristics
Among others, the following treatment characteristics will be assessed for each treatment line: dose
Time frame: Through study completion, median expected within 100 months
Treatment characteristics
Among others, the following treatment characteristics will be assessed for each treatment line: inpatient or outpatient setting
Time frame: Through study completion, median expected within 100 months
Concomitant treatments best supportive care (BSC)
Concomitant best supportive care (BSC) measures (e.g. number of transfusions, growth factors, iron chelators)
Time frame: Through study completion, median expected within 100 months
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.
Time frame: Through study completion, median expected within 100 months
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"
Time frame: Through study completion, median expected within 100 months
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