Actively Recruiting

Age: 18Years +
All Genders
NCT06764511

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliera -Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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