NCT06764511 Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome
| NCT ID | NCT06764511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Myelodysplastic Syndromes (MDS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-30 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-08-30 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Stefania Paolini, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06764511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndromes (MDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06764511 currently recruiting?
Yes, NCT06764511 is actively recruiting participants. Contact the research team at stefania.paolini@unibo.it for enrollment information.
Where is the NCT06764511 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06764511 clinical trial?
NCT06764511 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Stefania Paolini, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 60 participants.