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

NCT07839858 | Completed

• 1 other identifier: CINC424BFR01
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 51

Brief 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. 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.

Conditions

Polycythemia Vera

Keywords

Polycythemia Vera; Second-line cytoreductive treatment; Real-world data

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients per Type of Second-line Cytoreductive Treatment

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

Secondary Outcomes (39)

• Proportion of Patients per Type of First-line Cytoreductive Treatment

  Baseline

• Proportion of Patients per Type of Third-line Cytoreductive Treatment

  Up to approximately 12 months

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

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

• Duration of Each Line of Treatment

  Baseline up to approximately 12 months

• Duration Between PV Diagnosis and Second-line Cytoreductive Treatment Initiation

  Baseline

Study Arms (1)

PV Cohort

Adult PV patients who received a first dose of a second-line cytoreductive treatment between 1 January 2022 and 31 December 2023.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (51)

Novartis Investigative Site

Bayonne, Bayonne Cedex, 64109, France

Location

Novartis Investigative Site

Saint Priest Jarez, Pays de la Loire Region, 42270, France

Location

Novartis Investigative Site

Aix-en-Provence, 13616, France

Location

Novartis Investigative Site

Amiens, 80054, France

Location

Novartis Investigative Site

Angers, 49933, France

Location

Novartis Investigative Site

Antony, 92160, France

Location

Novartis Investigative Site

Arras, 62022, France

Location

Novartis Investigative Site

Aurillac, 15000, France

Location

Novartis Investigative Site

Avignon, 84000, France

Location

Novartis Investigative Site

Béziers, 34525, France

Location

Novartis Investigative Site

Bordeaux, 33076, France

Location

Novartis Investigative Site

Brest, 29200, France

Location

Novartis Investigative Site

Cesson-Sévigné, 35576, France

Location

Novartis Investigative Site

Challes-les-Eaux, 73190, France

Location

Novartis Investigative Site

Chambéry, 73000, France

Location

Novartis Investigative Site

Clermont-Ferrand, 63003, France

Location

Novartis Investigative Site

Corbeil-Essonnes, 91100, France

Location

Novartis Investigative Site

Dunkirk, 59240, France

Location

Novartis Investigative Site

Essey-lès-Nancy, 54270, France

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Le Bouscat, 33110, France

Location

Novartis Investigative Site

Le Chesnay, 78150, France

Location

Novartis Investigative Site

Le Coudray, 28630, France

Location

Novartis Investigative Site

Le Kremlin-Bicêtre, 94275, France

Location

Novartis Investigative Site

Le Mans, 72000, France

Location

Novartis Investigative Site

Libourne, 33505, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Marseille, 13005, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Morlaix Cdex, 29672, France

Location

Novartis Investigative Site

Nantes, 44277, France

Location

Novartis Investigative Site

Nîmes, 30029, France

Location

Novartis Investigative Site

Orléans, 45100, France

Location

Novartis Investigative Site

Paris, 75013, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Paris, 75475, France

Location

Novartis Investigative Site

Perpignan, 66046, France

Location

Novartis Investigative Site

Pessac, 33604, France

Location

Novartis Investigative Site

Pierre-Bénite, 69310, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Quimper, 29000, France

Location

Novartis Investigative Site

Rennescedex9, 35033, France

Location

Novartis Investigative Site

Rochefort, 17301, France

Location

Novartis Investigative Site

Roubaix, 59100, France

Location

Novartis Investigative Site

Saint-Brieuc, 22000, France

Location

Novartis Investigative Site

St-Malo, 35400, France

Location

Novartis Investigative Site

Strasbourg, 67085, France

Location

Novartis Investigative Site

Trévenans, 90400, France

Location

Novartis Investigative Site

Troyes, 10003, France

Location

MeSH Terms

Conditions

Polycythemia Vera

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: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: March 13, 2025
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (51)