Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Confirmed diagnosis of Polycythemia vera (according to WHO 2008, 2016, or 2022 criteria)
Eastern Cooperative Oncology Group (ECOG) ≤ 2
No previous pharmacologic cytoreductive therapy (including investigational drugs)
No phlebotomy in last 28 days

HU-eligible

High-risk: age ≥ 60 years and/or prior history of thrombosis

Low-risk: showing at least one of the defined criteria

Signs of disease progression (myeloproliferation)
Increasing risk of thromboembolism and bleeding:
Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.

Exclusion Criteria:

Patients with post- polycythemia vera myelofibrosis (post-PV MF) or accelerated phase/ blast phase myeloproliferative neoplasm acute myeloid leukemia (AP/BP-MPN AML)
Patients with a contraindication to HU according to the SmPC (severe bone marrow depression, leukopenia (< 2.5 x 109 leukocytes/l), thrombocytopenia (< 100 x 109 platelets/L), severe anemia (< 10 g/dL HGB)
Patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption in their past medical history
Active uncontrolled infection that is considered by the Investigator as a reason for exclusion
Active malignancies (except for skin cancer; prostate cancer and breast cancer in remission and - where necessary - ongoing hormonal therapy)
Inadequate liver function as assessed by Investigator
Inadequate renal function as demonstrated by Modification of Diet in Renal Disease estimate glomerular filtration rate (MDRDeGFR) < 30 mL/min/1.73m2 or on dialysis
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test.
Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 6 months after stopping study treatment.
HIV patients treated with nucleoside reverse transcriptase inhibitors like didanosine and stavudine

Other inclusion/exclusion criteria may apply