Checking How Patients With Myelodysplastic Syndrome Respond to Biosimilar Erythropoietin Alfa
Observes response to biosimilar erythropoietin alfa in adults with myelodysplastic syndrome and anemia.
Plain-language title generated from the registry record
Registry title: Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome
Key facts
- Where
- Bologna, ItalySee the site
Where in Italy
- IRCCS Azienda Ospedaliera-Universitaria di BolognaBologna, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Trial code
- NCT06764511
- Record updated
- 8 January 2025
- Original description
The primary objective of this study is to describe the response to treatment with biosimilar EPO alpha in MDS patients who had already been treated with "originator" EPO alpha and were responsive, and in patients who started treatment with biosimilar EPO alphaRead full original descriptionShow less
Valutazione Della Risposta Alla Terapia Con Eritropoietina Alfa Biosimilare Nei Pazienti Anemici Affetti da Sindrome Mielodisplastica
The primary objective of this study is to describe the response to treatment with biosimilar EPO alpha in MDS patients who had already been treated with "originator" EPO alpha and were responsive, and in patients who started treatment with biosimilar EPO alpha
Inclusion: MDS patients with symptomatic anemia (pre-treatment hemoglobin < 10g/dL) who started treatment with biosimilar EPO alpha, diagnosed according to the WHO 2016 classification, and characterized by very low, low, or intermediate IPSS-R risk and a pre-treatment serum EPO level < 500 U/L, who started treatment with biosimilar EPO alpha at the U. O. of Hematology of IRCCS AOUBO during the period from 01/06/2018 to 31/12/2021; Age ≥ 18 years at the time of enrollment; Acquisition of informed consent to study participation and data processing.
Exclusion: Concomitant treatment with antineoplastic cytotoxic drugs; - Presence of other possible contributory causes of anemia (e.g., anemia from chronic inflammatory disease, hemolysis, hemorrhage); Very impaired general clinical condition (ECOG performance status > 3); Poor compliance with treatment.