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

NCT ID: NCT06092879

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-06

Study Completion Date

2026-12-15

Brief Summary

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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.

Detailed Description

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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

Conditions

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Chronic Myeloid Leukemia

Keywords

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Chronic myeloid leukemia CML asciminib France

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Asciminib

Adult patients with Ph+ CML-CP previously treated with two or more tyrosine kinase inhibitors

Asciminib

Intervention Type OTHER

There is no treatment allocation. Patients administered Asciminib by prescription will be enrolled

Interventions

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Asciminib

There is no treatment allocation. Patients administered Asciminib by prescription will be enrolled

Intervention Type OTHER

Other Intervention Names

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Scemblix

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Angers, France, France

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Novartis Investigative Site

Challes-les-Eaux, France, France

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Limoges, Haute Vienne, France

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Saint Priest Jarez, Pays de la Loire Region, France

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Aix-en-Provence, , France

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Amiens, , France

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Antibes, , France

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Avignon, , France

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Besançon, , France

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Bobigny, , France

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Bordeaux, , France

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Bordeaux, , France

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Brest, , France

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Brive-la-Gaillarde, , France

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Caen, , France

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Cagnes-sur-Mer, , France

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Cannes, , France

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Castelnau-le-Lez, , France

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Cesson-Sévigné, , France

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Chambéry, , France

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Clermont-Ferrand, , France

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Corbeil-Essonnes, , France

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Dunkirk, , France

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Essey-lès-Nancy, , France

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Grenoble, , France

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Le Kremlin-Bicêtre, , France

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Le Mans, , France

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Lens, , France

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Libourne, , France

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Lorient, , France

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Lyon, , France

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Montpellier, , France

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Montpellier, , France

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Mulhouse, , France

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Nantes, , France

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Nevers, , France

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Nice, , France

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Nîmes, , France

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Orléans, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Perpignan, , France

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Périgueux, , France

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Pierre-Bénite, , France

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Poitiers, , France

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Quimper, , France

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Rennes, , France

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Roubaix, , France

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St-Malo, , France

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Strasbourg, , France

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Tarbes, , France

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Toulouse, , France

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Tours, , France

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Trévenans, , France

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Troyes, , France

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Valence, , France

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Vandœuvre-lès-Nancy, , France

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Novartis Investigative Site

Vesoul, , France

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Countries

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France

Other Identifiers

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CABL001AFR04

Identifier Type: -

Identifier Source: org_study_id