Austrian Myeloid Registry
ConditionMyeloid Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorArbeitsgemeinschaft medikamentoese Tumortherapie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >17 years
Diagnosis of myeloid disease according to WHO 2016
Signed patient informed consent (IC)
Disqualifiers
Patient is unable or unwilling to sign IC
Trial population
Patients with AML, MDS, CMML or PMF according to WHO 2016 diagnostic criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-interventional
Other interventionOnly 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.
Treatment groups
3,000 Participants
are divided into 4 treatment groupsGroup A: AML1 intervention
Group B: MDS1 intervention
Group C: CMML1 intervention
Group D: PMF1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Impact of front-line treatment on overall survival (OS)
Time frame
Through study completion, median expected within 100 months2
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 months3
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 months4
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 monthsOther outcomes
1
Minimal residual disease
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 months2
MRD-negativity on OS
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 months3
Prognostic and predictive markers
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
Time frame
Through study completion, median expected within 100 monthsSponsors and contacts
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Source ClinicalTrials.gov