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NCT Number: NCT06092879

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged ≥ 18 years at inclusion,
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Asciminib

Other

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

Other names: Scemblix

Primary outcomes

  1. Proportion of patients remaining on asciminib at 12 months

    Time frame: Month 12

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

Secondary outcomes

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

    Time frame: 12 months

    Molecular response to treatment: Response to treatment (MMR, BCR::ABL1 ≤ 0.1% on the International Scale, IS) at 12 months (+/- 1 month) for patients not in MMR at treatment initiation

  2. Proportion of patients in MMR - for patients in MMR at treatment initiation

    Time frame: 12 months

    Molecular response to treatment: Maintenance of molecular response (MMR, BCR::ABL1 ≤ 0.1% on the International Scale, IS) at 12 months (+/- 1 month) for patients in MMR at treatment initiation

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

    Time frame: 3 months, 6 months, 9 months, 12 months and 15 months

    Molecular response to treatment: Kinetics of response: MR2, MMR, MR4.0, MR4.5, undetectable MR4.5 for all patients.

    MR2, MR4, MR4.5 are defined as the transcript ratio of BCR-ABL1/ABL1 being 1% or less, 0.01% or less and 0.0032% or less respectively

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

    Time frame: 15 months

    Kinetics of response: BCR::ABL1 on the International Scale (IS) for all patients

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

    Time frame: Up to 15 months

    Kinetics of response: Time to MMR for patients not in MMR at treatment initiation

  6. Time from the first MMR to the first loss of MMR - for patients not in MMR at treatment initiation

    Time frame: Up to 15 months

    Molecular response to treatment: Duration of MMR for patients not in MMR at treatment initiation

  7. Event-Free Surviva (EFS)

    Time frame: Up to 15 months

    EFS: time from index date to occurrence of one the events listed among variables:

    • lack of efficacy, i.e., BRC::ABL1>1% or loss of CCyR if assessed
    • disease progression (CML-AP/BP, CML death)
    • death from any cause
    • definitive treatment discontinuation due to any reason

  8. Progression-Free Survival (PFS)

    Time frame: Up to 15 months

    PFS: time from index date to occurrence of one of the progression markers listed among variables:

    • disease progression (CML-AP/BP, CML death),
    • death from any cause,
    • definitive treatment discontinuation due to any reason

  9. Comorbidity profile

    Time frame: Baseline

    Charlson comorbidity index (CCI) at index date

  10. Disease characteristics

    Time frame: Baseline

    Disease characteristics to be provided

  11. History of TKI treatment

    Time frame: Baseline

    History of TKI treatment to be provided

  12. Management of patients in real-life

    Time frame: 15 months

    Concomitant medications

  13. Exposure patterns to asciminib

    Time frame: 15 months

    Exposure patterns to be provided

  14. EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)

    Time frame: Baseline, 3months, 6months, 9months, 12months, 15months

    The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role functioning, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status/Quality of Life (QOL) scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from "Not at all" to "Very much." The two questions concerning global health status/ QOL have 7 point scales with ratings ranging from "Very poor" to "Excellent." For each of the 14 domains, final scores are transformed such that they range from 0-100, where higher scores indicate improvement.

  15. EORTC QLQ-CML24 questionnaire

    Time frame: Baseline, 3months, 6months, 9months, 12months, 15months

    The EORTC QLQ-CML24 was designed to supplement the QLQ-C30 - the QLQ-CML24 is not a stand-alone instrument but is to be used in conjunction with the QLQ-C30.

    The EORTC QLQ-CML 24 is composed of four multi-item scales and two single-item scales. The module consists of 24 items assessing symptoms burden (13 items), impact on worry/mood (4 items), impact on daily life (3 items), satisfaction with care and information (2 items) body image problems (1 item) and satisfaction with social life (1 item). The items were measured on four levels: 1=not at all, 2=a little, 3=quite a bit, 4=very much. For each domain, scores were averaged and transformed to 0 to 100. A higher score in satisfaction with social life domain indicates a higher level of satisfaction. A positive change from baseline indicates increasing satisfaction.

  16. Emergence of mutations

    Time frame: Up to 15 months

    If available at end of treatment: mutational analysis, methods and results

  17. Proportion of patient with an AE described during asciminib treatment among patient reporting the same AE which led to discontinuation with previous TKI treatments

    Time frame: Up to 15 months

    Cross intolerance with previous TKI treatments

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: ASSURE-3

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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