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NCT Number: NCT05853445

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

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.

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Key information

Conditions

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

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Heidenheim, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Jakavi

Other

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

Other names: Ruxolitinib

Primary outcomes

  1. Dosing

    Time frame: Up to 36 months

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

  2. Treatment interruptions

    Time frame: Up to 36 months

    Number of patients with treatment interruptions

  3. Overall survival

    Time frame: Up to 36 months

    Overall survival for JAK inhibitor naive and pretreated patients

  4. Hematology

    Time frame: Up to 36 months

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

  5. Number of phlebotomies

    Time frame: Up to 36 months

    Total number of phlebotomies

  6. Change in spleen size (or volume)

    Time frame: Up to 36 months

    Measured by palpation/sonography/CT/MRI

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

    Time frame: Up to 36 months

    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.

  8. Thromboembolic events

    Time frame: Up to 36 months

    Number of patients with thromboembolic events.

Secondary outcomes

  1. Eastern Cooperative Oncology Group (ECOG) performance status

    Time frame: Up to 36 months

    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)

  2. Change in constitutional symptoms

    Time frame: Up to 36 months

    Number of patients with change in constitutional symptoms

  3. Quality of Life (QoL) - (SF-36)

    Time frame: Up to 36 months

    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.

  4. Bone marrow aspiration and biopsy

    Time frame: Up to 36 months

    Number of Biopsies per visit

  5. Molecular examination

    Time frame: Up to 36 months

    Number of performed assessments of JAK2V617F mutation per visist

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PAVE

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 10, 2023
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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