Actively Recruiting
Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients with Myelodysplastic Syndrome
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the response to treatment with biosimilar erythropoietin alfa (EPO alpha) in patients with Myelodysplastic Syndrome (MDS) who have anemia. The study focuses on patients who either previously responded to original EPO alpha treatment or who are starting biosimilar EPO alpha for the first time. This research aims to understand the effectiveness and safety of biosimilar EPO alpha in MDS patients, as current data are limited and mainly extrapolated from other conditions with anemia. Participants are included if they have symptomatic anemia with hemoglobin below 10 g/dL, are classified within very low, low, or intermediate risk groups according to the IPSS-R, and have a serum EPO level under 500 U/L before treatment. The study observes patients who started biosimilar EPO alpha treatment between June 2018 and December 2021. This is an observational study, so it follows patients without assigning specific treatments but collects data on their response and clinical outcomes over time. During the study period, researchers will monitor the response to biosimilar EPO alpha treatment and maintain observation for six months from study start. They will assess the overall response rate and track major clinical outcomes related to treatment administration. Participants will have their health and treatment progress evaluated through data collection, including blood tests and clinical assessments, to measure safety and effectiveness in a real-life setting.
CONDITIONS
Brief Title
Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Myelodysplastic Syndrome (MDS) with symptomatic anemia (hemoglobin < 10 g/dL)
- Classified as very low, low, or intermediate risk by IPSS-R
- Pre-treatment serum erythropoietin (EPO) level below 500 U/L
- Started biosimilar EPO alfa treatment between June 1, 2018 and December 31, 2021
- Provided informed consent for study participation and data processing
You will not qualify if you...
- Presence of other causes of anemia such as chronic inflammatory disease, hemolysis, or hemorrhage
- Poor compliance with treatment
- Very impaired general health condition (ECOG performance status greater than 3)
- Currently receiving antineoplastic cytotoxic drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months from the start of the study
Participants who are receiving biosimilar erythropoietin alfa treatment for anemia associated with Myelodysplastic Syndrome are observed to evaluate their response and safety outcomes.
Visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliera -Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
S
Stefania Paolini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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