Evaluating the response to a biosimilar treatment for anemia in MDS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the response of patients with Myelodysplastic Syndromes (MDS) to biosimilar Erythropoietin Alfa therapy. It focuses on patients who have previously responded to the originator EPO alpha and those starting treatment with the biosimilar. The study will analyze real-life data to determine the efficacy and safety of this treatment in symptomatic anemia cases. The goal is to fill the gap in existing knowledge regarding biosimilar ESAs in MDS patients, as current data is limited and primarily based on other conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

* \- 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

Where it's running

• IRCCS Azienda Ospedaliera -Universitaria di Bologna
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Stefania Paolini, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Stefania Paolini, MD
• Email: stefania.paolini@unibo.it
• Phone: +390512143680

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.