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

NCT06092879 | Active Not Recruiting

• 1 other identifier: CABL001AFR04
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 59

Brief 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.

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemia; CML; asciminib; France

Outcome Measures

Primary Outcomes (1)

• Proportion of patients remaining on asciminib at 12 months

  Proportion of patients remaining on asciminib treatment at 12 months to be provided

  Month 12

Secondary Outcomes (17)

• Proportion of patients in major molecular response (MMR) - for patients not in MMR at treatment initiation

  12 months

• Proportion of patients in MMR - for patients in MMR at treatment initiation

  12 months

• Proportion of patients in MR2, MMR, MR4.0, MR4.5, uMR4.5 - for all patients

  3 months, 6 months, 9 months, 12 months and 15 months

• BCR::ABL1 on the International Scale (IS) kinetics along treatment - for all patients

  15 months

• Time to MMR from the index date - for patients not in MMR at treatment initiation

  Up to 15 months

Study Arms (1)

Asciminib

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

Other: Asciminib

Interventions

Asciminib OTHER

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

Also known as: Scemblix

Asciminib

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

Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors

You may qualify if:

• Patient with Ph+ CML-CP previously treated with two or more TKIs,
• 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,
• Patient having given their non objection to participate to the study

You may not qualify if:

• Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment,
• Patient with known history of T315I mutation,
• Patient who previously received asciminib treatment,
• Patient currently participating to an interventional clinical trial,
• Patient with known contra-indication to asciminib according to the SmPC.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (59)

Novartis Investigative Site

Angers, France, 49933, France

Location

Novartis Investigative Site

Challes-les-Eaux, France, 73190, France

Location

Novartis Investigative Site

Limoges, Haute Vienne, 87000, 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

Antibes, 06600, France

Location

Novartis Investigative Site

Avignon, 84000, France

Location

Novartis Investigative Site

Besançon, 25030, France

Location

Novartis Investigative Site

Bobigny, 93009, France

Location

Novartis Investigative Site

Bordeaux, 33000, France

Location

Novartis Investigative Site

Bordeaux, 33076, France

Location

Novartis Investigative Site

Brest, 29609, France

Location

Novartis Investigative Site

Brive-la-Gaillarde, 19100, France

Location

Novartis Investigative Site

Caen, 14033, France

Location

Novartis Investigative Site

Cagnes-sur-Mer, 06800, France

Location

Novartis Investigative Site

Cannes, 06414, France

Location

Novartis Investigative Site

Castelnau-le-Lez, 34170, France

Location

Novartis Investigative Site

Cesson-Sévigné, 35576, 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 Kremlin-Bicêtre, 94275, France

Location

Novartis Investigative Site

Le Mans, 72000, France

Location

Novartis Investigative Site

Lens, 62307, France

Location

Novartis Investigative Site

Libourne, 33505, France

Location

Novartis Investigative Site

Lorient, 56100, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Montpellier, 34070, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Mulhouse, 68070, France

Location

Novartis Investigative Site

Nantes, 44277, France

Location

Novartis Investigative Site

Nevers, 58000, France

Location

Novartis Investigative Site

Nice, 06105, 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, 75015, France

Location

Novartis Investigative Site

Paris, 75475, France

Location

Novartis Investigative Site

Perpignan, 66046, France

Location

Novartis Investigative Site

Périgueux, 24019, France

Location

Novartis Investigative Site

Pierre-Bénite, 69495, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Quimper, 29000, France

Location

Novartis Investigative Site

Rennes, 35033, France

Location

Novartis Investigative Site

Roubaix, 59100, France

Location

Novartis Investigative Site

St-Malo, 35403, France

Location

Novartis Investigative Site

Strasbourg, 67085, France

Location

Novartis Investigative Site

Tarbes, 65100, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Tours, 37044, France

Location

Novartis Investigative Site

Trévenans, 90400, France

Location

Novartis Investigative Site

Troyes, 10003, France

Location

Novartis Investigative Site

Valence, 26953, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

Location

Novartis Investigative Site

Vesoul, 70014, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

asciminib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: March 6, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (59)