A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera

NCT05853445 | Completed

• 1 other identifier: CINC424BDE12
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 99

Brief Summary

Jakavi® therapy for polycythemia vera (PV) has so far been studied exclusively in clinical trials and at selected clinical trial centres. This observational study is intended to document the therapy of PV in daily practice with a broad patient population and a geographically representative selection of German centres (both hospitals and practices). The prospective mapping of daily practice reality is thus the main goal of this project.

Conditions

Polycythemia Vera

Keywords

ruxolitinib; polycythemia vera; PV; jakavi

Outcome Measures

Primary Outcomes (8)

• Dosing

  Number of patients by initial dosing and number of patients with dose modifications will be provided

  Up to 36 months

• Treatment interruptions

  Number of patients with treatment interruptions

  Up to 36 months

• Overall survival

  Overall survival for JAK inhibitor naive and pretreated patients

  Up to 36 months

• Hematology

  Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes)

  Up to 36 months

• Number of phlebotomies

  Total number of phlebotomies

  Up to 36 months

• Change in spleen size (or volume)

  Measured by palpation/sonography/CT/MRI

  Up to 36 months

• Quality of Life (QoL) - MPN-SAF TSS; MPN-10

  The Myeloproliferative Neoplasm (MPN) Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; MPN-10) questionnaire contains the ten most clinically relevant symptoms reported by patients with MPNs. It includes disease related symptoms each scored from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity.

  Up to 36 months

• Thromboembolic events

  Number of patients with thromboembolic events.

  Up to 36 months

Secondary Outcomes (5)

• Eastern Cooperative Oncology Group (ECOG) performance status

  Up to 36 months

• Change in constitutional symptoms

  Up to 36 months

• Quality of Life (QoL) - (SF-36)

  Up to 36 months

• Bone marrow aspiration and biopsy

  Up to 36 months

• Molecular examination

  Up to 36 months

Study Arms (2)

JAK inhibitor naive

JAK inhibitor naive patients

Other: Jakavi

JAK inhibitor pre-treated

JAK inhibitor pre-treated patients (Jakavi® or any other JAK inhibitor for ≥3 months)

Other: Jakavi

Interventions

Jakavi OTHER

Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.

Also known as: Ruxolitinib

JAK inhibitor naive; JAK inhibitor pre-treated

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with PV for whom Jakavi® therapy is indicated.

You may qualify if:

• Adult male and female patients with PV for whom Jakavi® therapy is indicated according to the European summary of product characteristics
• Patients who have been informed about this NIS and gave written consent

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (99)

Novartis Investigative Site

Heidenheim, Baden-Wurttemberg, 89518, Germany

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Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68305, Germany

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Reutlingen, Baden-Wurttemberg, 72764, Germany

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Winnenden, Baden-Wurttemberg, 71364, Germany

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Aschaffenburg, Bavaria, 63739, Germany

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Augsburg, Bavaria, 86152, Germany

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Donauwörth, Bavaria, 86609, Germany

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Erlangen, Bavaria, 91052, Germany

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Herrsching am Ammersee, Bavaria, 82211, Germany

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Munich, Bavaria, 80639, Germany

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Munich, Bavaria, 81241, Germany

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Frankfurt (Oder), Brandenburg, 15236, Germany

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Landshut, Bvaria, 84036, Germany

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Brake, Lower Saxony, 26919, Germany

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Göttingen, Lower Saxony, 37073, Germany

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Twistringen, Lower Saxony, 27239, Germany

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Duisburg, North Rhine-Westphalia, 47166, Germany

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Bad Salzuflen, Northrhine Westfalia, 32105, Germany

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Iserlohn, Northrhine Westfalia, 58644, Germany

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Bautzen, Saxony, 02625, Germany

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Dresden, Saxony, 01127, Germany

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Pirna, Saxony, 01796, Germany

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Lübeck, Schleswig-Holstein, 23563, Germany

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Erfurt, Thuringia, 99084, Germany

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Altötting, 84503, Germany

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Augsburg, 86150, Germany

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Bad Homburg, 61348, Germany

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Bad Soden, 65812, Germany

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Berlin, 12351, Germany

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Berlin, 13357, Germany

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Bielefeld, 33604, Germany

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Bottrop, 46236, Germany

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Chemnitz, 09113, Germany

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Cologne, 50671, Germany

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Cologne, 51103, Germany

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Dortmund, 44263, Germany

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Dresden, 01307, Germany

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Duisburg, 47166, Germany

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Düren, 52353, Germany

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Erfurt, 99085, Germany

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Essen, 45136, Germany

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Essen, 45147, Germany

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Fürth, 90766, Germany

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Gera, 07548, Germany

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Goslar, 38642, Germany

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Halberstadt, 38820, Germany

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Halle, 06110, Germany

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Hamburg, 20259, Germany

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Hamburg, 22081, Germany

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Hamelin, 31785, Germany

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Hamm, 59063, Germany

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Hamm, 59065, Germany

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Hanover, 30161, Germany

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Hanover, 30170, Germany

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Heidelberg, 69115, Germany

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Heilbronn, 74072, Germany

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Hildesheim, 31134, Germany

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Hildesheim, 31135, Germany

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Hof, 95028, Germany

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Idar-Oberstein, 55743, Germany

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Kaiserslautern, 67655, Germany

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Koblenz, 56068, Germany

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Kronach, 96317, Germany

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Leipzig, 04289, Germany

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Lemgo, 32657, Germany

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Loerrach, 79539, Germany

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Lüdenscheid, 58507, Germany

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Magdeburg, 39104, Germany

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Marburg, 35037, Germany

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Mayen, 56727, Germany

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Memmingen, 87700, Germany

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Minden, 32429, Germany

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Moers, 47441, Germany

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Mülheim, 45468, Germany

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Münster, 48149, Germany

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Naunhof, 04683, Germany

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Nordhorn, 48527, Germany

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Nuremberg, 90403, Germany

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Nuremberg, 90419, Germany

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Nuremberg, 90449, Germany

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Offenburg, 77654, Germany

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Oldenburg, 26121, Germany

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Passau, 94036, Germany

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Porta Westfalica, 32457, Germany

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Potsdam, 14467, Germany

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Rostock, 18057, Germany

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Rostock, 18059, Germany

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Rüsselsheim am Main, 65428, Germany

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Schorndorf, 73614, Germany

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Schöneck, 08621, Germany

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Stolberg, 52222, Germany

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Stuttgart, 70174, Germany

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Stuttgart, 70178, Germany

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Westerstede, 26655, Germany

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Wiesbaden, 65189, Germany

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Wittenberg, 06886, Germany

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Wolfsburg, 38440, Germany

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Würselen, 52146, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

Location

Related Links

• Results for CINC424BDE12 that is getting linked from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Polycythemia Vera

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: August 17, 2015
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (99)