Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a treatment called biosimilar Erythropoietin Alfa (EPO alpha) works for patients with a condition known as Myelodysplastic Syndromes (MDS), specifically for those experiencing anemia, which means they have low levels of red blood cells. The researchers want to see how patients, who have previously responded to the original EPO alpha treatment, respond to the new biosimilar version. Additionally, they are looking at patients who are starting treatment with the biosimilar for the first time.

To be eligible for this trial, participants must be adults aged 18 or older who have been diagnosed with MDS and have significant anemia (with hemoglobin levels below 10 g/dL). They also need to have a specific type of MDS that falls into a low-risk category and a pre-treatment level of EPO in their blood that is less than 500 U/L. Patients with other causes of anemia or those receiving certain other treatments will not be included in the study. If you join the trial, you will receive the biosimilar EPO alpha and be monitored to see how your body responds to this treatment. This study aims to help improve care for patients with MDS and anemia.

Gender

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Eligibility criteria

• 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