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
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Diagnosed with Myelodysplastic Syndrome (MDS) according to WHO 2016 classification
- Symptomatic anemia with hemoglobin less than 10 g/dL before treatment
- Very low, low, or intermediate risk by IPSS-R score
- Serum erythropoietin level less than 500 U/L before treatment
- Started biosimilar EPO alpha treatment at the specified hematology center between June 2018 and December 2021
- Age 18 years or older at enrollment
- Provided informed consent for study participation and data use
You will not qualify if you...
- Other possible causes of anemia such as chronic inflammatory disease, hemolysis, or hemorrhage
- Poor compliance with treatment
- Very poor general health with ECOG performance status greater than 3
- Receiving antineoplastic cytotoxic drug treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliera -Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
S
Stefania Paolini, MD
CONTACT
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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