HU-F-AIM - A prospective, interventional clinical study to evaluate hydroxyurea (HU) resistance in patients with polycythaemia vera who meet prediction parameters identified in the PV-AIM project using artificial intelligence

Prior treatment

• HIV patients treated with nucleoside reverse transcriptase inhibitors like didanosine and stavudine

Other illness

• Active uncontrolled infection that is considered by the Investigator as a reason for exclusion
• Active malignancies (except for carcinoma in situ; prostate cancer and breast cancer in remission and – where necessary - ongoing hormonal therapy)
• 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

Lab values

• Patients with a contraindication to HU according to the SmPC (severe bone marrow depression, leukopenia (< 2.5 x 10^9 leukocytes/l), thrombocytopenia (< 100 x 10^9 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
• 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.

Other

• Patients with post- polycythemia vera myelofibrosis (post-PV MF) or accelerated phase/ blast phase myeloproliferative neoplasm acute myeloid leukemia (AP/BP-MPN AML)
• Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 3 months after stopping study treatment.

• Signed informed consent must be obtained prior to participation in the study
• Patients ≥ 18 years
• 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 14 days
• HU-eligible • High-risk: age ≥ 60 years and/or prior history of thrombosis • Low-risk: showing at least one of the defined criteria o Signs of disease progression (myeloproliferation) o 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.