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Polycythemia VeraVeRavieNCT07839858

A Study of Real-world Use and Effectiveness of Cytoreductive Strategies for the Treatment of Second-line Polycythemia Vera in France

An observational study of Polycythemia Vera, run by Novartis Pharmaceuticals at 51 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to assess which cytoreductive treatments are currently administered in standard practice as second-line therapy to patients with polycythemia vera (PV) in France and to find out the reasons physicians switch treatments. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Polycythemia Vera
How many people
237 participants
Where
51 sitesFrance
Study dates
13 Mar 2025to 14 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with PV who received a first dose of a second-line cytoreductive treatment between 1 January 2022 and 31 December 2023.

Who may be able to join

  • Male or female patient diagnosed with PV after 01 Jan 2014 according to World Health Organization (WHO) criteria.
  • Patient ≥ 18 years of age at the time of PV diagnosis.
  • Patient who received a first dose of a second-line cytoreductive treatment between 01 Jan 2022 and 31 Dec 2023.

Who cannot join

  • Patient alive at study initiation who opposed to data use for research purposes.
  • Patient who died before study initiation and who had opposed to data use for research purpose prior to their death.
  • Patient who took part in an interventional clinical trial(s) between 01 January 2022 and 31 December 2023.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

France51 sites

  • Novartis Investigative Site

    Aix-en-Provence, 13616

  • Novartis Investigative Site

    Amiens, 80054

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Antony, 92160

  • Novartis Investigative Site

    Arras, 62022

  • Novartis Investigative Site

    Aurillac, 15000

  • Novartis Investigative Site

    Avignon, 84000

  • Novartis Investigative Site

    Bayonne, Bayonne Cedex, 64109

  • Novartis Investigative Site

    Béziers, 34525

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Cesson-Sévigné, 35576

  • Novartis Investigative Site

    Challes-les-Eaux, 73190

  • Novartis Investigative Site

    Chambéry, 73000

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Dunkirk, 59240

  • Novartis Investigative Site

    Essey-lès-Nancy, 54270

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Le Bouscat, 33110

  • Novartis Investigative Site

    Le Chesnay, 78150

  • Novartis Investigative Site

    Le Coudray, 28630

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Libourne, 33505

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Marseille, 13005

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Morlaix Cdex, 29672

  • Novartis Investigative Site

    Nantes, 44277

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Orléans, 45100

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Paris, 75475

  • Novartis Investigative Site

    Perpignan, 66046

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Pierre-Bénite, 69310

  • Novartis Investigative Site

    Poitiers, 86021

  • Novartis Investigative Site

    Quimper, 29000

  • Novartis Investigative Site

    Rennescedex9, 35033

  • Novartis Investigative Site

    Rochefort, 17301

  • Novartis Investigative Site

    Roubaix, 59100

  • Novartis Investigative Site

    Saint Priest Jarez, Pays de la Loire Region, 42270

  • Novartis Investigative Site

    Saint-Brieuc, 22000

  • Novartis Investigative Site

    St-Malo, 35400

  • Novartis Investigative Site

    Strasbourg, 67085

  • Novartis Investigative Site

    Trévenans, 90400

  • Novartis Investigative Site

    Troyes, 10003

Other trials in France

About this study

Official title: Real-world Use and Effectiveness of Cytoreductive Strategies for the Treatment of Second-line Polycythemia Vera: A Multicenter, Retrospective, Non-interventional Study in France

The aim of this study was to assess which cytoreductive treatments are currently administered in standard practice as second-line therapy to patients with polycythemia vera (PV) in France and to find out the reasons physicians switch treatments. In addition, the research aimed to describe real-world effectiveness of second-line cytoreductive therapies and the occurrence of adverse events of special interest.

Study data were collected from the medical charts of patients who initiated a second-line cytoreductive agent for the treatment of PV and received their first dose between 1 Jan 2022 and 31 Dec 2023.

Keywords
Polycythemia Vera, Second-line cytoreductive treatment, Real-world data
Medical subject headings
Polycythemia Vera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07839858
Study groupRoleWhat they receive
PV CohortAdult PV patients who received a first dose of a second-line cytoreductive treatment between 1 January 2022 and 31 December 2023.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients per Type of Second-line Cytoreductive Treatment

    Measured: Day 1 (first dose of second-line cytoreductive treatment)

Secondary outcomes (39)

  1. Proportion of Patients per Type of First-line Cytoreductive Treatment

    Measured: Baseline

  2. Proportion of Patients per Type of Third-line Cytoreductive Treatment

    Measured: Up to approximately 12 months

  3. Initial Dose of Second-line Cytoreductive Treatment Received for Each Type of Treatment

    Measured: Day 1 (first dose of second-line cytoreductive treatment)

  4. Duration of Each Line of Treatment

    Measured: Baseline up to approximately 12 months

  5. Duration Between PV Diagnosis and Second-line Cytoreductive Treatment Initiation

    Measured: Baseline

  6. Proportion of Patients With Treatment Interruptions and Dose Modification During Second-line Treatment

    Measured: Up to approximately 12 months

  7. Proportion of Patients by Number of Dose Modifications During Second-line Cytoreductive Treatment

    Dose modifications were categorized as an increase or decrease in dose.

    Measured: Up to approximately 12 months

  8. Proportion of Patients Who Permanently Discontinued Second-line Cytoreductive Treatment

    Measured: Up to approximately 12 months

  9. Proportion of Patients by Reasons for Switching to Second-line Cytoreductive Treatment

    Measured: Baseline

  10. Proportion of Patients by Reasons for Switching to Third-line Cytoreductive Treatment

    Measured: Up to approximately 12 months

  11. Proportion of Patients per Type of Concomitant Treatment/Procedure During Second-line Cytoreductive Treatment

    Measured: Up to approximately 12 months

  12. Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to First-line Cytoreductive Treatment

    Timing of bone marrow biopsy was categorized as:

    • Prior to first-line treatment
    • Prior to second-line treatment

    Measured: Baseline

  13. Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to Second-line Cytoreductive Treatment

    Timing of bone marrow biopsy was categorized as:

    • During second-line treatment
    • After second-line treatment

    Measured: Baseline

  14. Proportion of Patients Achieving Hematocrit Control

    Hematocrit control was defined as hematocrit < 45% with the absence of phlebotomy eligibility during the last 3 months.

    Measured: Approximately 6 months

  15. Proportion of Patients Achieving Clinicohematologic Response

    Proportion of patients achieving clinicohematologic response according to the European LeukemiaNet (ELN) criteria (complete or partial).

    Complete clinicohematologic response was defined by:

    • Hematocrit < 45% without phlebotomies during the last 3 months, and
    • Platelet count ≤ 400 x 10^9/L, and
    • White blood cell count ≤ 10 x 10^9/L, and
    • Normal spleen size evaluated by physical examination and/or by imaging.

    Partial clinicohematologic response was defined by:

    In patients who do not fulfill the criteria for complete response, hematocrit < 45% without phlebotomy for 3 months OR response in 3 of the other criteria.

    Measured: Approximately 6 months

  16. Proportion of Patients Achieving Symptom Response

    Proportion of patients achieving symptom response according to the ELN criteria. Symptom response is defined as an absolute 10-point improvement in the Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS).

    The MPN-SAF TSS (or MPN-10) is a validated patient-reported questionnaire that measures symptom burden in patients with myeloproliferative neoplasms. The instrument assesses 10 key disease-related symptoms, each scored from 0 (absent) to 10 (worst imaginable), generating a total score ranging from 0 to 100. Higher scores indicate greater symptom burden, and changes in the score are commonly used to evaluate clinical benefit and treatment response in both clinical practice and clinical trials

    Measured: Approximately 6 months

  17. Proportion of Patients Achieving Molecular Response

    Proportion of patients achieving molecular response according to the ELN criteria (complete or partial).

    Complete molecular response was defined by the reduction of any specific molecular abnormality to undetectable levels.

    Partial molecular response was defined by:

    • A reduction of ≥ 50% from baseline value in patients with < 50% mutant allele burden at baseline OR
    • A reduction of ≥ 25% from baseline value in patients with ≥ 50% mutant allele burden at baseline.

    Measured: Approximately 6 months

  18. Proportion of Patients With Occurrence of Disease Progression Events

    Disease progression events include acute myeloid leukemia, myelofibrosis, and PV related death.

    Measured: Up to 6 approximately months

  19. Proportion of Patients With Occurrence of Thromboembolic or Hemorrhagic Events

    Thromboembolic and hemorrhagic events include arterial thrombotic, venous thrombotic, and hemorrhage.

    Measured: Up to 6 approximately months

  20. Proportion of Patients by Sex

    Measured: Day 1 (first dose of second-line cytoreductive treatment)

  21. Age

    Measured: Day 1 (first dose of second-line cytoreductive treatment)

  22. Proportion of Patients With Cardiovascular and Thromboembolic Risk Factors

    Measured: Baseline

  23. Proportion of Patients With a History of Medical Conditions

    Medical conditions include cancer, autoimmune disease, and opportunistic infection.

    Measured: Baseline

  24. Proportion of Patients With Other Ongoing Comorbidities

    Measured: Baseline

  25. Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Prior to First-line Treatment

    Measured: Baseline

  26. Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Between First- and Second-line Cytoreductive Treatment

    Measured: Baseline

  27. Duration Between Most Recent Thromboembolic or Hemorrhagic Event and Initiation of First and Second-line Cytoreductive Treatment

    Measured: Baseline

  28. Proportion of Patients by Reason for Initiating First-line Cytoreductive Treatment

    Measured: Baseline

  29. Proportion of Patients per Type of Pre-specified Emergency Treatment/Procedure Administered Prior to Second-line Cytoreductive Treatment Initiation

    Emergency treatments/procedures include antiplatelet drugs, anticoagulants, and phlebotomies.

    Measured: Baseline

  30. Proportion of Patients by Number of Phlebotomies Required in the 3 Months Prior to Second-line Cytoreductive Treatment

    Measured: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

  31. Proportion of Patients by PV Symptoms

    PV symptoms include splenomegaly, pruritus, fatigue, and bone pain.

    Measured: Day 1 (first dose of second-line cytoreductive treatment)

  32. MPN-SAF TSS Score

    The MPN-SAF TSS (or MPN-10) is a validated patient-reported questionnaire that measures symptom burden in patients with myeloproliferative neoplasms. The instrument assesses 10 key disease-related symptoms, each scored from 0 (absent) to 10 (worst imaginable), generating a total score ranging from 0 to 100. Higher scores indicate greater symptom burden, and changes in the score are commonly used to evaluate clinical benefit and treatment response in both clinical practice and clinical trials.

    Measured: Day 1 (first dose of second-line cytoreductive treatment)

  33. Hemoglobin Level

    Measured: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

  34. Hematocrit Level

    Measured: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

  35. Leukocyte Count

    Measured: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

  36. Platelet Count

    Measured: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

  37. Proportion of Patients by Type of Mutation

    Measured: Baseline

  38. Mutant Allele Burden

    Mutant allele burden is a molecular measure that quantifies the proportion of cells harboring a specific disease-associated mutation (e.g., JAK2 V617F, CALR, or MPL) within a patient sample. It is usually reported as the variant allele frequency (VAF), representing the percentage of mutant alleles among all alleles analyzed, and serves as an indicator of the size of the malignant clone in myeloproliferative neoplasms (MPNs). Changes in mutant allele burden may provide insight into the biological activity of the disease and the molecular effects of therapy.

    Mutant allele burden was categorized as ≥ 50% or < 50%.

    Measured: Baseline

  39. Proportion of Patients With Pre-specified Adverse Events of Special Interest Occurring After Initiation of the Second-line Cytoreductive Treatment

    Pre-specified adverse events of special interest include thrombocytopenia, anemia, neutropenia, infection, weight gain, psychological disorders, nonmelanoma skin cancer, skin disorders, and autoimmune disorders.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study start13 Mar 2025
  3. Primary completion14 Oct 2025
  4. Study completion14 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07839858
Sponsor's protocol ID
CINC424BFR01
Acronym
VeRavie
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Polycythemia Vera, run by Novartis Pharmaceuticals at 51 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients per Type of Second-line Cytoreductive Treatment (time frame: Day 1 (first dose of second-line cytoreductive treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07839858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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