Spots Global Cancer Trial Database for Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors
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Trial Identification
Brief Title: Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors
Official Title: 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
Study ID: NCT05853458
Conditions
Interventions
Study Description
Brief 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 cell distribution width (RDW) ≥17%) identified by machine learning in the polycythemia vera advanced integrated model (PV-AIM) project in the real-life setting
Detailed Description: This is an open-label, prospective, single arm, Phase IV interventional study to evaluate the HU-resistance/intolerance in PV patients who meet predictive parameters identified in the machine learning project PV-AIM. The study consists of three periods: screening period, treatment period (observation for HU-resistance/intolerance) and follow-up (FU) period. Eligible participants will enter the treatment period (observation for HU-resistance/intolerance) and start receiving the de novo HU treatment. The maximum treatment duration for each participant in the study will be up to 15 months. This study will be conducted in a total of 300 adult PV patients and approximately at 30 sites in Germany.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Heidelberg, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Straubing, Bayern, Germany
Novartis Investigative Site, Langen, Hessen, Germany
Novartis Investigative Site, Lingen, Niedersachsen, Germany
Novartis Investigative Site, Dortmund, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Velbert, North Rhine-Westphalia, Germany
Novartis Investigative Site, Luebeck, Schleswig-Holstein, Germany
Novartis Investigative Site, Augsburg, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bonn, , Germany
Novartis Investigative Site, Donauwoerth, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Erding, , Germany
Novartis Investigative Site, Erfurt, , Germany
Novartis Investigative Site, Gera, , Germany
Novartis Investigative Site, Halle, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Kronach, , Germany
Novartis Investigative Site, Köln, , Germany
Novartis Investigative Site, Merseburg, , Germany
Novartis Investigative Site, Moers, , Germany
Novartis Investigative Site, Mutlangen, , Germany
Novartis Investigative Site, Naunhof, , Germany
Novartis Investigative Site, Offenburg, , Germany
Novartis Investigative Site, Torgau, , Germany
Novartis Investigative Site, Westerstede, , Germany
Novartis Investigative Site, Wuerselen, , Germany
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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