Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

Asciminib

Clinical Study ID

NCT06092879
CABL001AFR04
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients treated with asciminib, with a primary objective represented by maintenance on treatment at 12 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient aged ≥ 18 years at inclusion,

  2. Patient with Ph+ CML-CP previously treated with two or more TKIs,

  3. Patient for whom a decision has been taken by the treating physician (investigator)to initiate treatment with asciminib according to his own practice, the drug label /Summary of Product Characteristics (SmPC), and regardless of study participation,

  4. Patient having given their non objection to participate to the study

Exclusion

Exclusion Criteria:

  1. Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment,

  2. Patient with known history of T315I mutation,

  3. Patient who previously received asciminib treatment,

  4. Patient currently participating to an interventional clinical trial,

  5. Patient with known contra-indication to asciminib according to the SmPC.

Study Design

Total Participants: 168
Treatment Group(s): 1
Primary Treatment: Asciminib
Phase:
Study Start date:
March 06, 2024
Estimated Completion Date:
December 15, 2026

Study Description

The ASSURE-3 study is a national, multicentric, non-interventional, prospective study in real-life conditions with primary data collection in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more Tyrosine Kinase Inhibitors (TKIs). It will be conducted in France with hematologists, onco-hematologists, physicians with documented involvement in managing Ph+ CML-CP patients in routine practice, practicing in public or private health care institutions. Each patient will be followed during 15 months at M0, M1 and then every 3 months (rhythm of visits according to the routine clinical care), or until premature discontinuation of asciminib treatment.

Historical data will be abstracted retrospectively by the participating physicians from patient files, to collect information using an electronic case report form (eCRF). Primary data will be collected during inclusion and follow-up visits

Connect with a study center

  • Novartis Investigative Site

    Saint Priest en Jarez, Loire 42270
    France

    Active - Recruiting

  • Novartis Investigative Site

    Aix en Provence, 13616
    France

    Active - Recruiting

  • Novartis Investigative Site

    Amiens, 80054
    France

    Active - Recruiting

  • Novartis Investigative Site

    Angers Cedex 9, 49933
    France

    Active - Recruiting

  • Novartis Investigative Site

    Antibes, 06600
    France

    Active - Recruiting

  • Novartis Investigative Site

    Avignon, 84000
    France

    Active - Recruiting

  • Novartis Investigative Site

    Avignon cedex 9, 84902
    France

    Site Not Available

  • Novartis Investigative Site

    Besancon Cedex, 25030
    France

    Active - Recruiting

  • Novartis Investigative Site

    Bordeaux, 33000
    France

    Active - Recruiting

  • Novartis Investigative Site

    Brest, 29609
    France

    Active - Recruiting

  • Novartis Investigative Site

    Brive La Gaillarde, 19132
    France

    Active - Recruiting

  • Novartis Investigative Site

    Caen, 14033
    France

    Active - Recruiting

  • Novartis Investigative Site

    Cagnes Sur Mer, 06800
    France

    Site Not Available

  • Novartis Investigative Site

    Cannes, 06414
    France

    Active - Recruiting

  • Novartis Investigative Site

    Challes Les Eaux, 73190
    France

    Active - Recruiting

  • Novartis Investigative Site

    Dunkerque, 59385
    France

    Active - Recruiting

  • Novartis Investigative Site

    Grenoble, 38043
    France

    Active - Recruiting

  • Novartis Investigative Site

    Le Mans, 72000
    France

    Site Not Available

  • Novartis Investigative Site

    Lens, 62307
    France

    Active - Recruiting

  • Novartis Investigative Site

    Libourne, 33505
    France

    Site Not Available

  • Novartis Investigative Site

    Lyon, 69373
    France

    Site Not Available

  • Novartis Investigative Site

    Montpellier, 34070
    France

    Active - Recruiting

  • Novartis Investigative Site

    Mulhouse cedex, 68070
    France

    Active - Recruiting

  • Novartis Investigative Site

    Nice, 06105
    France

    Active - Recruiting

  • Novartis Investigative Site

    Nimes, 30029
    France

    Active - Recruiting

  • Novartis Investigative Site

    Orleans, 45100
    France

    Active - Recruiting

  • Novartis Investigative Site

    Perigueux, 24019
    France

    Active - Recruiting

  • Novartis Investigative Site

    Quimper, 29000
    France

    Active - Recruiting

  • Novartis Investigative Site

    RENNES Cedex 9, 35033
    France

    Site Not Available

  • Novartis Investigative Site

    Rennes, 35043
    France

    Active - Recruiting

  • Novartis Investigative Site

    ST Malo Cedex, 35403
    France

    Active - Recruiting

  • Novartis Investigative Site

    Strasbourg cedex, 67085
    France

    Active - Recruiting

  • Novartis Investigative Site

    Tarbes, 65100
    France

    Active - Recruiting

  • Novartis Investigative Site

    Tours, 37044
    France

    Active - Recruiting

  • Novartis Investigative Site

    Trevenans, 90400
    France

    Active - Recruiting

  • Novartis Investigative Site

    Troyes, 10003
    France

    Active - Recruiting

  • Novartis Investigative Site

    Valence Cedex 9, 26953
    France

    Active - Recruiting

  • Novartis Investigative Site

    Vesoul, 70014
    France

    Active - Recruiting

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