Evaluating the response to a biosimilar treatment for anemia in MDS patients
Valutazione Della Risposta Alla Terapia Con Eritropoietina Alfa Biosimilare Nei Pazienti Anemici Affetti da Sindrome Mielodisplastica
This study is testing how well a new version of an anemia treatment works for people with Myelodysplastic Syndromes who have either responded to the original treatment before or are starting it for the first time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06764511 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the response of patients with Myelodysplastic Syndromes (MDS) to biosimilar Erythropoietin Alfa therapy. It focuses on patients who have previously responded to the originator EPO alpha and those starting treatment with the biosimilar. The study will analyze real-life data to determine the efficacy and safety of this treatment in symptomatic anemia cases. The goal is to fill the gap in existing knowledge regarding biosimilar ESAs in MDS patients, as current data is limited and primarily based on other conditions.
Who should consider this trial
Good fit: Ideal candidates include adults with symptomatic anemia due to MDS, characterized by low to intermediate risk and specific pre-treatment criteria.
Not a fit: Patients with other causes of anemia or those receiving cytotoxic chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of biosimilar EPO alpha, potentially improving treatment options for anemic MDS patients.
How similar studies have performed: While there is limited data on biosimilar ESAs in MDS, similar studies in other anemia contexts have shown positive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliera -Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Stefania Paolini, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Stefania Paolini, MD
- Email: stefania.paolini@unibo.it
- Phone: +390512143680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.