NCT Number: NCT04438889
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie, Feldkirch, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Through study completion, median expected within 100 months
Time frame: Through study completion, median expected within 100 months
Time frame: 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.
Time frame: 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
Time frame: Through study completion, median expected within 100 months
Time to transformation to AML for patients with a non-AML initial diagnosis
Time frame: 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).
Time frame: Through study completion, median expected within 100 months
Concomitant treatments (number of administration of e.g. prophylactic antibiotics, antivirals, antifungals)
Time frame: Through study completion, median expected within 100 months
Among others, the following treatment characteristics will be assessed for each treatment line: substance
Time frame: Through study completion, median expected within 100 months
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
Among others, the following treatment characteristics will be assessed for each treatment line: route
Time frame: Through study completion, median expected within 100 months
Among others, the following treatment characteristics will be assessed for each treatment line: dose
Time frame: 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
Time frame: Through study completion, median expected within 100 months
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
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
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
Assess how many and which patients in Austria have minimal residual disease (MRD) assessments, assessed by which techniques and at which timepoints.
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Daniela Wolkersdorfer
CONTACT
Lisa Pleyer, MD
CONTACT
Arbeitsgemeinschaft medikamentoese Tumortherapie
Other
Acronym: aMYELOIDr
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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