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
Researchers are evaluating the response to a biosimilar form of erythropoietin alpha (EPO alpha) in patients with Myelodysplastic Syndromes (MDS) who have anemia. This study focuses on patients who were previously treated with the original EPO alpha and responded, as well as those who started treatment directly with the biosimilar. The goal is to better understand how effective and safe the biosimilar EPO alpha is in treating anemia related to MDS, a condition where bone marrow function is impaired. Prior studies have shown that erythropoiesis-stimulating agents (ESAs) can improve survival and quality of life in patients who respond to treatment, but data on biosimilar ESAs in MDS patients are limited. The study includes patients who started biosimilar EPO alpha treatment at a specific hematology center between June 2018 and December 2021. Participants are those with symptomatic anemia and low to intermediate risk MDS according to WHO classification and IPSS-R scoring, with certain laboratory criteria including serum EPO levels less than 500 U/L. There are no specific interventions or experimental groups mentioned, as the study is retrospective and observational, focusing on the treatment response over time. Participants' response to treatment is monitored for at least six months from the start of the study, focusing on the overall response rate (ORR) and its maintenance. Researchers review clinical and laboratory data, including regular hemoglobin measurements, to track improvements in anemia. Safety and treatment adherence are also considered. The total duration of participant involvement varies based on the treatment timeline and data available during the study period.
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
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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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