Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients
NCT ID: NCT05582902
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2022-10-11
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of lower-risk myelodysplastic neoplasms (MDS; IPSS-R very low, low, intermediate up to 3.5 points) or MDS/MPN overlap including MDS/MPN-RS-T, MDS/MPNu, aCML or non-proliferative chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO) criteria as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC)
* Symptomatic transfusion dependent (TD) anemia defined as having received ≥3 units of red blood cells (RBC) within the last 16 weeks prior to screening according to the International Working Group (IWG) criteria for MDS (Platzbecker et al. 2019)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
University of Leipzig
OTHER
Responsible Party
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Anne Sophie Kubasch
Principal Investigator
Locations
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Universitätsklinik Innsbruck
Innsbruck, , Austria
Charité Universitätsmedizin Berlin
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Jena
Jena, , Germany
University Hospital Leipzig
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Friedrich-Ebert-Krankenhaus GmbH
Neumünster, , Germany
Countries
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Central Contacts
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Facility Contacts
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Dominik Wolf, Prof. Dr.
Role: primary
Kathrin Rieger, Dr.
Role: primary
Mathias Hänel, PD Dr.
Role: primary
Thomas Illmer, PD Dr.
Role: primary
Katja Sockel, Dr.
Role: primary
Ulrich Germing, Prof.
Role: primary
Olaposi Yomade, Dr.
Role: primary
Beatrice Berneck, Dr.
Role: primary
Daniel Sasca, Dr. med.
Role: primary
Daniel Nowak, Prof. Dr.
Role: primary
Stefan Mahlmann, Dr.
Role: primary
Other Identifiers
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PRO-RED study
Identifier Type: -
Identifier Source: org_study_id
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