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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
EU CTIS ID: 2022-502338-20-00
What this study is testing
Evaluation of HU-resistance/intolerance in PV patients who meet the predictive risk factors identified in the machine learning project PV-AIM (referred to as: PV-AIM HU-resistance predictors) at start of their regular HU-treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 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
- 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
See the full eligibility 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)
- 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.
- 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 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
- 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.
- HIV patients treated with nucleoside reverse transcriptase inhibitors like didanosine and stavudine
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.