Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AIFA-RSO-3948 | Other Identifier | A.O.U. Federico II Napoli |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Polycythemia Vera Receiving Ropeginterferon aplha 2b | Data will be collected retrospectively from patient medical records and will include:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropeginterferon alfa-2b (BESREMi®) | Drug | Ropeginterferon Alfa-2b was administered in accordance with the approved prescribing information. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera | Definition: Proportion of patients achieving Complete Hematologic Response (CHR) or Partial Response (PR) at each scheduled timepoint (3, 6, 9, 12, 18 and 24 months), classified according to the ELN criteria and identification of baseline and on-treatment factors associated with (a) first attainment of CHR/PR and (b) maintenance (duration) of CHR/PR. Assessment timepoints: Baseline, 3, 6, 9, 12, 18 and 24 months (or last available follow-up). Summary metrics: Proportion (%) in CHR and PR at each timepoint | From enrollment to the end of treatment or at least 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hematologic Response | Time (in months) from the first day of Ropeginterferon Alfa-2b treatment to achievement of CHR or PR hematologic response according to ELN criteria. | Baseline to first documented CHR or PR (up to 24 months) |
| Duration of Hematologic Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The study will include patients diagnosed with Polycythemia Vera (PV) according to current diagnostic criteria who have received at least one administration of Ropeginterferon Alfa-2b (BESREMI) as part of their disease management. Eligible patients must have complete clinical and laboratory information available and must be followed at one of the participating centers. All participants must provide written informed consent prior to inclusion in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novella Pugliese, MD, PhD | Contact | +393396137232 | novypugliese@yahoo.it |
Not provided
Not provided
Individual Participant Data (IPD) will not be shared to protect participant privacy and to comply with ethical and regulatory requirements.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Interval between first documented CHR or PR and loss of that response, death, or last follow-up. |
| From first CHR/PR to loss or last follow-up (up to 24 months) |
| Progression-Free Survival (PFS) | Time from treatment initiation to progression to post-PV myelofibrosis, acute myeloid leukemia, or death from any cause | Baseline to event or last follow-up (up to 24 months) |
| Thromboembolic Event Rate | Proportion of patients experiencing arterial or venous thrombotic or embolic events during treatment with Ropeginterferon. | Baseline to last follow-up (up to 24 months) |
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) CTCAE v6. | Baseline to last follow-up (up to 24 months) |
| Treatment Discontinuation | Proportion of patients who discontinue Ropeginterferon for adverse events, lack of efficacy, or other clinical reasons. | Baseline to last follow-up (up to 24 months) |
| Dose Modifications and Adherence | Number and proportion of patients with significant dose changes (reductions or increases) and estimated adherence (planned vs observed dosing intervals). | Baseline to last follow-up (up to 24 months) |
| Normalization of Hematologic Parameters | Proportion of patients achieving target hematologic values: hematocrit <45%, leukocytes <10000/mm³, platelets <400000/mm³. | Baseline and at scheduled visits (3,6,9,12,18,24 months) |
| JAK2 V617F Allele Burden | Assessment of JAK2 V617F allele burden dynamics during Ropeginterferon treatment and correlation with hematologic response. | Baseline and at scheduled visits (3,6,9,12,18,24 months) |