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

NCT06764511 | Recruiting

• 1 other identifier: EPO BIOSIM
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Myelodysplastic Syndromes (MDS)

Outcome Measures

Primary Outcomes (1)

• Response and maintenance of ORR

  response to treatment (ORR) (assessed according to the response criteria established by the International Working Group (23) in patients who initiated treatment with biosimilar EPO alfa \- maintenance of ORR (assessed according to the response criteria established by the International Working Group (23) from the date of biosimilar drug initiation), in patients previously on treatment and responsive to "originator" EPO alfa who were subsequently treated with biosimilar EPO alfa

  6 months from the start of the study

Secondary Outcomes (1)

• A measure of the frequency of major clinical outcomes in two groups of patients who had different modes of treatment administration with biosimilar EPO alpha

  6 months from the start of the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with MDS who started treatment with biosimilar EPO alpha at the "Seràgnoli" Institute, U.O. of Hematology of IRCCS AOU of Bologna during the period from 01 Jun 2018 to 31 Dec 2021 will be enrolled in the study. Specifically, the population will consist of * patients who initiated treatment after having already been treated with "originator" EPO alfa and responsive to treatment at the time of initiation of biosimilar EPO alfa, and * patients who started treatment without previous treatment with biosimilar EPO alfa

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliera -Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Stefania Paolini, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Paolini, MD

CONTACT

+390512143680; stefania.paolini@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: August 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 8, 2025

Record last verified: 2024-12

Locations

IT (1)