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
Key facts
- Where
- Aachen, Augsburg, Berlin, Bonn, Cologne, Donauwörth, Dortmund, Dresden, Erding, Erfurt, Frechen, Gera, Goslar, Guetersloh, Halle (Saale), Hannover, Heidelberg, Kiel, Kronach, Langen (Hessen), Lingen (Ems), Luebeck, Merseburg, Moers, Mutlangen, Naunhof, Saarbruecken, Straubing, Torgau, Tuebingen, Velbert, Westerstede és Würselen, NémetországSee the 33 sites
- Phase
- 4. fázis
Where in Németország
- M8 Studiengesellschaft GbRAachen, NémetországNo longer taking part
- Haematologie-Onkologie im Zentrum MVZ GmbHAugsburg, NémetországNo longer taking part
- Onkologisches Versorgungszentrum Friedrichshain Hämatologie, Onkologie und PalliativmedizinBerlin, NémetországNo longer taking part
- Johanniter GmbHBonn, NémetországNo longer taking part
- MVZ fuer Haematologie und Onkologie Koeln Am Sachsenring GmbHCologne, NémetországNo longer taking part
- Onkologisches Zentrum DonauwörthDonauwörth, NémetországNo longer taking part
- GEFOS Gesellschaft fuer onkologische Studien Dortmund mbHDortmund, NémetországNo longer taking part
- Gemeinschaftspraxis Hämatologie - OnkologieDresden, NémetországNo longer taking part
- Onkologie ErdingErding, NémetországNo longer taking part
- Onkologische Gemeinschaftspraxis Weniger / BitterichErfurt, NémetországNo longer taking part
- pioh Studien und Management GbRFrechen, NémetországNo longer taking part
- IOGP Internistisch, Onkologische GemeinschaftspraxisGera, NémetországNo longer taking part
- MVZ Onkologische Kooperation Harz GbRGoslar, NémetországNo longer taking part
- Onkodok GmbHGuetersloh, NémetországNo longer taking part
- Gemeinschaftspraxis Dr Med Regina Moeller Dr Med Tabea Appel Anett KrziwanieHalle (Saale), NémetországNo longer taking part
- Studienzentrum am RaschplatzHannover, NémetországNo longer taking part
- Onkologische Schwerpunktpraxis HeidelbergHeidelberg, NémetországNo longer taking part
- Praxis Dres. med. Bolouri und SchwabKiel, NémetországNo longer taking part
- Onkologische Schwerpunktpraxis Dr. AnhutKronach, NémetországNo longer taking part
- Gemeinschaftspraxis Fuer Haematologie Und OnkologieLangen (Hessen), NémetországNo longer taking part
- Bonifatius Hospital Lingen gGmbHLingen (Ems), NémetországNo longer taking part
- Luebecker Onkologische SchwerpunktpraxisLuebeck, NémetországNo longer taking part
- Carl-von-Basedow-Klinikum Saalekreis gGmbHMerseburg, NémetországNo longer taking part
- OnkoLog Moers GbRMoers, NémetországNo longer taking part
- Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen RechtsMutlangen, NémetországNo longer taking part
- Praxis Dr. med. Jens UhligNaunhof, NémetországNo longer taking part
- Med. Statistik SaarbrueckenSaarbruecken, NémetországNo longer taking part
- Barmherzige Brueder gemeinnuetzige Traeger GmbHStraubing, NémetországNo longer taking part
- Kreiskrankenhaus Torgau Johann Kentmann gGmbHTorgau, NémetországNo longer taking part
- MVZ Zentrum fuer ambulante Onkologie GmbHTuebingen, NémetországNo longer taking part
- MVZ-Onkologie Velbert GbRVelbert, NémetországNo longer taking part
- Medizinische Studiengesellschaft NORD-WEST GmbHWesterstede, NémetországNo longer taking part
- MVZ West GmbH Würselen Hämatologie/OnkologieWürselen, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma GmbH
- Trial code
- EU 2022-502338-20-00
- Record updated
- 2025. szeptember 11.
- Original description
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.Read full original descriptionShow less
HU-F-AIM - A prospective, interventional study to evaluate HU-resistance in polycythemia vera patients who meet predictive parameters identified in the machine learning project PV-AIM
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.
Inclusion: 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.
Exclusion: HIV patients treated with nucleoside reverse transcriptase inhibitors like didanosine and stavudine; 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; 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; 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.