Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study (MIRROR)

Federico II University

Status: Not yet enrolling

Conditions: Polycytemia Vera

Treatments: Drug: Ropeginterferon alfa-2b (BESREMi®)

Study type: Observational

Funder types: Other

Identifiers

NCT07282132

AIFA-RSO-3948 (Other Identifier)

Details and patient eligibility

About

This retrospective study aims to evaluate the effectiveness and safety of Ropeginterferon Alfa-2b (BESREMI) in patients with Polycythemia Vera (PV). Eligible patients have a confirmed PV diagnosis according to current criteria, have received at least one dose of Ropeginterferon, and have complete clinical and laboratory data available. The primary objective is to analyze the time course of hematologic response (complete or partial, CHR/PR) according to ELN criteria, and to identify clinical and treatment-related factors associated with achieving and maintaining response. Secondary objectives include time to response, duration of response, progression-free survival, thromboembolic event rate, safety and tolerability, treatment discontinuation, dose modifications and adherence, normalization of hematologic parameters, and changes in JAK2 V617F allele burden. Data will be collected retrospectively from medical records at participating centers.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Polycythemia Vera according to updated diagnostic criteria
• Have received at least one dose of Ropeginterferon Alfa-2b (BESREMI).
• Complete clinical and laboratory data availability for review (e.g., hematologic parameters, treatment response, adverse events).
• Followed at one of the participating study centers.
• Have signed informed consent for participation.

Exclusion criteria

• Have received experimental or non-approved treatments for PV during the observation period.
• Lack sufficient clinical or laboratory data to allow inclusion in the analysis.

Trial design

150 participants in 1 patient group

Patients with Polycythemia Vera Receiving Ropeginterferon aplha 2b

Description:

Data will be collected retrospectively from patient medical records and will include: 1. Demographic Data 2. Clinical Characteristics of PV 3. Treatment Information. Details on Ropeginterferon Alfa-2b therapy: Dosage; Treatment schedule and duration; Clinical and hematologic response; Treatment discontinuation and reasons for interruption 4. Clinical and Hematologic Response: Hematologic parameters (hemoglobin, hematocrit, platelet count, etc.); Clinical status during treatment; Spleen size assessed via abdominal ultrasound (when available); Documentation of baseline values, prior therapies, dosing schedules, and response assessments at: 3, 6, 9, 12, 18, and 24 months; Discontinuation rates and reasons for stopping therapy 5. Molecular Response: Quantification of JAK2 V617F allele burden over time 6. Adverse Events: Any clinically relevant complications or side effects

Treatment:

Drug: Ropeginterferon alfa-2b (BESREMi®)