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.
To achieve meaningful results in accordance with the study objective and to obtain long-term data from daily clinical practice in a real-world setting, the observation period under Jakavi® therapy is specified as 36 months.
Study Type
OBSERVATIONAL
Enrollment
467
Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.
Dosing
Number of patients by initial dosing and number of patients with dose modifications will be provided
Time frame: Up to 36 months
Treatment interruptions
Number of patients with treatment interruptions
Time frame: Up to 36 months
Overall survival
Overall survival for JAK inhibitor naive and pretreated patients
Time frame: Up to 36 months
Hematology
Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes)
Time frame: Up to 36 months
Number of phlebotomies
Total number of phlebotomies
Time frame: Up to 36 months
Change in spleen size (or volume)
Measured by palpation/sonography/CT/MRI
Time frame: 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.
Time frame: Up to 36 months
Thromboembolic events
Number of patients with thromboembolic events.
Time frame: Up to 36 months
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Novartis Investigative Site
Heidenheim, Baden-Wurttemberg, Germany
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany
Novartis Investigative Site
Reutlingen, Baden-Wurttemberg, Germany
Novartis Investigative Site
Winnenden, Baden-Wurttemberg, Germany
Novartis Investigative Site
Aschaffenburg, Bavaria, Germany
Novartis Investigative Site
Augsburg, Bavaria, Germany
Novartis Investigative Site
Donauwörth, Bavaria, Germany
Novartis Investigative Site
Erlangen, Bavaria, Germany
Novartis Investigative Site
Herrsching am Ammersee, Bavaria, Germany
Novartis Investigative Site
Munich, Bavaria, Germany
...and 89 more locations
Eastern Cooperative Oncology Group (ECOG) performance status
The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The grade ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead)
Time frame: Up to 36 months
Change in constitutional symptoms
Number of patients with change in constitutional symptoms
Time frame: Up to 36 months
Quality of Life (QoL) - (SF-36)
The Short Form-36 questionnaire consists of questions measuring physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitations, and mental health status. The scores that can be obtained from the scale vary between 0 and 100 and the increase in the scores indicates that the quality of life is high.
Time frame: Up to 36 months
Bone marrow aspiration and biopsy
Number of Biopsies per visit
Time frame: Up to 36 months
Molecular examination
Number of performed assessments of JAK2V617F mutation per visist
Time frame: Up to 36 months