Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors (NCT05853458) | Clinical Trial Compass
TerminatedPhase 4
Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors
Stopped: Sponsor decision
Germany76 participantsStarted 2023-07-28
Plain-language summary
The purpose of this study is to confirm the predictive factors for hydroxyurea (HU) failure (hemoglobin (HGB) \<15.5 g/dL (9.62 mmol/L) and red blood cell distribution width (RDW) ≥17%) identified by machine learning in the polycythemia vera advanced integrated model (PV-AIM) project in the real-life setting.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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) (Tefferi and Vardiman 2008, Arber et al 2016, Khoury et al 2022)
✓. Eastern Cooperative Oncology Group (ECOG) ≤ 2
✓. No previous pharmacologic cytoreductive therapy (including investigational drugs)
✓. No phlebotomy in last 14 days
✓. HU-eligible
✓. 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.
✕
What they're measuring
1
Proportion of PV patients with HU-resistance/intolerance within 6-9 months after start of de novo HU- treatment in presence of the PV-AIM HU-resistance predictors at the start of HU treatment.
Timeframe: From 6 to 9 months after start of de novo HU-treatment
. 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.
✕. 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 3 months after stopping study treatment.