Austrian Myeloid Registry

Recruiting

• Conditions: Myeloid Diseases
• Interventions: Other: Non-interventional

• Registration Number: NCT04438889
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Study Start: 2020-07-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDS	Non-interventional	Patients with WHO 2016 diagnosis of MDS
CMML	Non-interventional	Patients with WHO 2016 diagnosis of CMML
PMF	Non-interventional	Patients with WHO 2016 diagnosis of PMF
AML	Non-interventional	Patients with WHO 2016 diagnosis of AML

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Treatment characteristics	Through study completion, median expected within 100 months	Among others, the following treatment characteristics will be assessed for each treatment line: inpatient or outpatient setting
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.
AML transformation	Through study completion, median expected within 100 months	Time to transformation to AML for patients with a non-AML initial diagnosis
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.
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)
Impact of front-line treatment on overall survival (OS)	Through study completion, median expected within 100 months
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)
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"

Trial Locations

Locations (16)

LKH Hochsteiermark, Abteilung für Hämato-Onkologie; 🇦🇹 Leoben, Austria

LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie; 🇦🇹 Feldkirch, Austria

KH der Barmherzigen Brüder, Innere Medizin I; 🇦🇹 Graz, Austria

Universitätsklinik Innsbruck, Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie; 🇦🇹 Innsbruck, Austria

Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Hämatologie; 🇦🇹 Graz, Austria

Universitätsklinikum Krems, Innere Medizin II Hämato-Onkologie; 🇦🇹 Krems, Austria

Ordensklinikum Linz GmbH, Barmherzige Schwestern, Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie; 🇦🇹 Linz, Austria

Universitätsklinikum St. Pölten, Klinische Abteilung für Innere Medizin 1; 🇦🇹 St. Pölten, Austria

Klinikum Steyr, Innere Medizin II; 🇦🇹 Steyr, Austria

Klinik Donaustadt: 2. Medizinische Abteilung; 🇦🇹 Vienna, Austria

Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV; 🇦🇹 Wels, Austria

Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie; 🇦🇹 Linz, Austria

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

Universitätsklinik für Innere Med. III, PMU Salzburg; 🇦🇹 Salzburg, Austria

Hanusch KH, 3. Med. Abteilung; 🇦🇹 Wien, Austria

Klinik Ottakring, 1. Med. Abteilung; 🇦🇹 Wien, Austria