Austrian Myeloid Registry (aMYELOIDr)

April 9, 2025 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniela Wolkersdorfer
  • Phone Number: +436626404412
  • Email: office@agmt.at

Study Contact Backup

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • Recruiting
        • LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie
        • Contact:
          • Bernd Hartmann, MD
      • Graz, Austria, 8020
        • Recruiting
        • KH der Barmherzigen Brüder, Innere Medizin I
        • Contact:
          • Andrea Hammerl-Steiner, MD
      • Graz, Austria, 8036
        • Not yet recruiting
        • Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Hämatologie
        • Contact:
          • Armin Zebisch, MD
      • Innsbruck, Austria, 6020
        • Recruiting
        • Universitätsklinik Innsbruck, Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie
        • Contact:
          • Dominik Wolf, MD
      • Krems, Austria, 3500
        • Recruiting
        • Universitätsklinikum Krems, Innere Medizin II Hämato-Onkologie
        • Contact:
          • Martin Pecherstorfer, MD
      • Leoben, Austria, 8700
        • Recruiting
        • LKH Hochsteiermark, Abteilung für Hämato-Onkologie
        • Contact:
          • Angelika PICHLER, MD
      • Linz, Austria, 4010
        • Recruiting
        • Ordensklinikum Linz GmbH, Barmherzige Schwestern, Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie
        • Contact:
          • Gregor Aschauer, MD
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
        • Contact:
          • Sigrid Machherndl-Spandl, MD
      • Linz, Austria, 4021
        • Recruiting
        • Kepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie
        • Contact:
          • Clemens Schmitt, MD
      • Salzburg, Austria, 5020
        • Recruiting
        • Universitätsklinik für Innere Med. III, PMU Salzburg
        • Contact:
          • Lisa Pleyer, MD
      • St. Pölten, Austria, 3100
        • Recruiting
        • Universitätsklinikum St. Pölten, Klinische Abteilung für Innere Medizin 1
        • Contact:
          • Petra PICHLER, MD
      • Steyr, Austria, 4400
        • Recruiting
        • Klinikum Steyr, Innere Medizin II
        • Contact:
          • Johannes Andel, MD
      • Vienna, Austria, 1220
        • Recruiting
        • Klinik Donaustadt: 2. Medizinische Abteilung
        • Contact:
          • Margarete Stampfl-Mattersberger, MD
      • Wels, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
        • Contact:
          • Sonja HEIBL, MD
      • Wien, Austria, 1140
        • Recruiting
        • Hanusch KH, 3. Med. Abteilung
        • Contact:
          • Felix Keil, MD
      • Wien, Austria, 1160
        • Recruiting
        • Klinik Ottakring, 1. Med. Abteilung
        • Contact:
          • Martin Schreder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with AML, MDS, CMML or PMF according to WHO 2016 diagnostic criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AML
Patients with WHO 2016 diagnosis of AML
Other: Non-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.
MDS
Patients with WHO 2016 diagnosis of MDS
Other: Non-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.
CMML
Patients with WHO 2016 diagnosis of CMML
Other: Non-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.
PMF
Patients with WHO 2016 diagnosis of PMF
Other: Non-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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of front-line treatment on overall survival (OS)
Time Frame: Through study completion, median expected within 100 months
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
Through study completion, median expected within 100 months
Overall response rate (ORR)
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.
Through study completion, median expected within 100 months
Event free survival (EFS)
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
Through study completion, median expected within 100 months
AML transformation
Time Frame: Through study completion, median expected within 100 months
Time to transformation to AML for patients with a non-AML initial diagnosis
Through study completion, median expected within 100 months
Treatment safety
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).
Through study completion, median expected within 100 months
Concomitant treatments
Time Frame: Through study completion, median expected within 100 months
Concomitant treatments (number of administration of e.g. prophylactic antibiotics, antivirals, antifungals)
Through study completion, median expected within 100 months
Treatment characteristics
Time Frame: Through study completion, median expected within 100 months
Among others, the following treatment characteristics will be assessed for each treatment line: substance
Through study completion, median expected within 100 months
Treatment characteristics
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
Through study completion, median expected within 100 months
Treatment characteristics
Time Frame: Through study completion, median expected within 100 months
Among others, the following treatment characteristics will be assessed for each treatment line: route
Through study completion, median expected within 100 months
Treatment characteristics
Time Frame: Through study completion, median expected within 100 months
Among others, the following treatment characteristics will be assessed for each treatment line: dose
Through study completion, median expected within 100 months
Treatment characteristics
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
Through study completion, median expected within 100 months
Concomitant treatments best supportive care (BSC)
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)
Through study completion, median expected within 100 months
Quality of life assessment EQ-5D-5L (optional)
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.
Through study completion, median expected within 100 months
EORTC Quality of life assessment QLQ-C30 (optional)
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"
Through study completion, median expected within 100 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal residual disease
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.
Through study completion, median expected within 100 months
MRD-negativity on OS
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.
Through study completion, median expected within 100 months
Prognostic and predictive markers
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
Through study completion, median expected within 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Investigators

  • Principal Investigator: Lisa Pleyer, MD, 3rd Med Dept Paracelsus Medical University, Salzburg
  • Study Chair: Richard Greil, MD, AGMT gemeinnützige GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AGMT_aMYELOIDr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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