Polycythemia vera Polycythemia vera, PV
Conditions
Interventions
None listed
Sponsors
Takenaka Katsuto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Polycythemia vera (PV) patients that meet the diagnostic criteria of the WHO classification, 4th revised edition (2017) or 5th edition (2023) 2)Patients with JAK2V617F gene mutation 3)Patients in which ropegIFN therapy is newly started 4)Subjects in which JAK2V617F allele burden can be measured using ipsogen JAK2 DX reagent 5) Patients who have been fully informed of the contents of this study and have given their written consent 6)Patients aged 18 years or older at the time of obtaining consent
Exclusion criteria
Exclusion criteria: 1)Patients whose pathological findings from bone marrow biopsy cannot rule out myelodysplastic syndrome (MDS) 2)Patients with an administration history of ropegIFN and peg-interferon 3)Patients for whom the use of ropegIFN is contraindicated based on the package insert (Patients with a history of hypersensitivity to the components of this drug, other interferon preparations, or biological preparations such as vaccines/Patients currently receiving Shosaikoto/Patients with autoimmune hepatitis/Patients with decompensated liver disease) 4)Patients with active hepatitis B virus, hepatitis C virus, or HIV infection (even if the virus test is positive, but it is not active, the patient is eligible.) 5)Other patients who the investigator deems inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of JAK2V617F allele burden <10% with ropegIFN | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Complete molecular response rate and partial response rate 2)Complete hematologic response rate 3)Occurrence of thrombotic events 4)Occurrence of hemorrhagic events 5)Occurrence of disease type transition (secondary myelofibrosis/acute leukemia/myelodysplastic syndrome), occurrence of secondary cancer 6)Operational cure achievement rate 7)Adverse events of ropegIFN 8)Continuation duration of ropegIFN 9)Association between total dose and initial dose of ropegIFN, and molecular response 10)Association between total dose and initial dose of ropegIFN, and hematological response 11)Maintenance duration of JAK2V617F allele burden <10% 12)Maximum reduction rate in JAK2V617F allele burden 13)Association between JAK2V617F allele burden at the time of stopping ropegIFN and subsequent recurrence 14)Association between achievement of JAK2V617F allele burden <10% and background factors 15)Association between achievement of JAK2V617F allele burden <10% and disease type transition | — |
Contacts
Public ContactMasaki Maruta
Ehime University Hospital
Outcome results
None listed