RecruitingNCT06764511
Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome
Valutazione Della Risposta Alla Terapia Con Eritropoietina Alfa Biosimilare Nei Pazienti Anemici Affetti da Sindrome Mielodisplastica
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
60 participants
Start Date
Aug 30, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria4
- \- Presence of other possible contributory causes of anemia (e.g., anemia from chronic inflammatory disease, hemolysis, hemorrhage)
- Poor compliance with treatment
- Very impaired general clinical condition (ECOG performance status > 3)
- Concomitant treatment with antineoplastic cytotoxic drugs
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06764511
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