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Completed

NCT Number: NCT06516029

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

A retrospective, non-interventional cohort study design using data obtained from the Flatiron Health oncology electronic health record (EHR)-derived de-identified database, was used to address the study objectives.

The overall asciminib cohort included adult patients with Philadelphia positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CML-CP), with or without the T3151 mutation, who initiated asciminib in any line of therapy. The third-line or later (3L+) asciminib cohort included adult patients with Ph+ CML-CP who did not have T315I mutation and initiated asciminib after prior use of at least 2 different tyrosine kinase inhibitors (TKIs) or omacetaxine. The 3L asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of 2 different TKIs or omacetaxine. The fourth-line or later (4L+) asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of at least 3 different TKIs or omacetaxine.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who initiated asciminib as identified by Flatiron through the Flatiron Health-Novartis Scemblix CML Spotlight database study.
  • Patients had at least one diagnosis for CML (International Classification of Diseases, 9th Edition, Clinical Modification [ICD-9-CM]: 205.1x; International Classification of Diseases, 10th Edition, Clinical Modification [ICD-10-CM]: C92.1x).
  • Diagnosed with CP as identified by Flatiron through chart abstraction.
  • Had 2 or more documented clinical visits, on different days in the Flatiron data on or after 1 January 2011.
  • Had evidence of treatment with asciminib on or after Food and Drug Administration (FDA) approval date (29 October 2021), with data granularity availability at least at the month level for dates of asciminib use.
  • Had CML initial diagnosis date on or after 1 January 2011.
  • Had 1 or more clinical activity within 6 months prior to asciminib initiation (e.g., medical visit, medication order, lab test, etc.).

Exclusion criteria

  • Patients who did not meet inclusion criteria listed above.
  • Had stem-cell transplant (SCT) on or prior to asciminib initiation or unknown SCT date.
  • Diagnosed with CML in accelerated phase (AP) or blast crisis (BC) before asciminib initiation, as identified by Flatiron through chart abstraction, or had blast greater than 15% or unknown blast result within 60 days prior to asciminib initiation.
  • Patients had received a clinical study drug between 15 November 2017 and 4 December 2019 (randomization dates for the ASCEMBL trial).

Treatment and study plan

Primary outcomes

  1. Age at Index Date

    Time frame: Up to 137 months

    Index date was defined as the date of initiation for asciminib.

  2. Gender at Index Date

    Time frame: Up to 137 months

    Index date was defined as the date of initiation for asciminib.

  3. Race at Index Date

    Time frame: Up to 137 months

    Index date was defined as the date of initiation for asciminib.

  4. Type of Practice at Index Date

    Time frame: Up to 137 months

    Types of practices included: community and academic practices. Index date was defined as the date of initiation for asciminib.

  5. Eastern Cooperative Oncology Group Performance Score (ECOG-PS) at Index Date

    Time frame: Up to 137 months

    ECOG-PS describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores ranged from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 4 (completely disabled; cannot carry on any selfcare; totally confined to bed or chair).

    Index date was defined as the date of initiation for asciminib.

  6. Number of Patients Categorized by the Five Most Common Baseline Comorbidities

    Time frame: Baseline

    Baseline was defined as the time between the date of initial CML diagnosis up to (and excluding) the date of asciminib initiation (index date).

  7. Number of Patients Categorized by Last Molecular Response (MR) Achieved Within 3-months Prior to Index Date

    Time frame: Up to 3 months pre-index date

    MR categories included:

    • MR0 (BCR::ABL1 greater than 10%)
    • MR1 (BCR::ABL1 less than or equal to 10%)
    • MR2 (BCR::ABL1 less than or equal to 1%)
    • MR3/Major MR (BCR::ABL1 less than or equal to 0.1%)
    • MR4 or better (BCR::ABL1 less than or equal to 0.01%)

    Index date was defined as the date of initiation for asciminib.

  8. Median Duration of Observation from Index Date to the end of the Study Period

    Time frame: Up to 13 months

    The study period was defined as the time between the index date (inclusive) until the earliest of stem-cell transplant (SCT), death, loss-to-follow-up (i.e., last activity in the electronic medical record data), or end of data availability (i.e., 30 November 2022). The index date was the date of initiation for asciminib.

  9. Number of Patients by First Observed Line of Therapy with Asciminib at Index Date

    Time frame: Up to 137 months

    Index date was defined as the date of initiation for asciminib.

  10. Number of Patients Categorized by Dosage of Asciminib at Index Date

    Time frame: Up to 137 months

    Index date was defined as the date of initiation for asciminib.

  11. Number of Patients by Status at End of First Observed Line of Therapy with Asciminib

    Time frame: From date of asciminib initiation to end of study period, up to 13 months

    Status:

    • Continued asciminib treatment (included dose change/held).
    • Discontinued asciminib treatment.

  12. Number of Patients by Type of First Tyrosine Kinase Inhibitor (TKI) Received Before Asciminib Initiation

    Time frame: Up to 137 months

  13. Number of Patients by Type of TKI Received Immediately Before Asciminib Initiation

    Time frame: Up to 137 months

  14. Number of Patients by Type of TKI Received Anytime Before Asciminib Initiation

    Time frame: Up to 137 months

  15. Number of Patients by Most Common Treatment Sequence

    Time frame: From initial CML diagnosis until the end of study period, up to 143 months

  16. Asciminib Treatment Persistence Rate Post-Index Date

    Time frame: Week 12, week 24 post-index date

    Index date was defined as the date of initiation for asciminib.

Secondary outcomes

  1. Number of Patients Categorized by Best Molecular Response (MR) Achieved Within 12-months Post-index Date

    Time frame: 12 months post-index date

    MR categories included:

    • MR0 (BCR::ABL1 greater than 10%)
    • MR1 (BCR::ABL1 less than or equal to 10%)
    • MR2 (BCR::ABL1 less than or equal to 1%)
    • MR3/Major MR (BCR::ABL1 less than or equal to 0.1%)
    • MR4 or better (BCR::ABL1 less than or equal to 0.01%)

    Index date was defined as the date of initiation for asciminib.

  2. Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR3/Major MR (MMR)

    Time frame: Week 12, week 24 post-index date

    MR3/MMR was defined as BCR::ABL1 less than or equal to 0.1%. Index date was defined as the date of initiation for asciminib.

  3. Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR2

    Time frame: Week 12, week 24 post-index date

    MR2 was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib.

  4. Number of Patients Without MR3/MMR Prior to Asciminib Initiation who Achieved MR3/MMR Post-index Date

    Time frame: Week 12, week 24 post-index date

    MR3/MMR was defined as BCR::ABL1 less than or equal to 0.1%. Index date was defined as the date of initiation for asciminib.

  5. Median Time to MR3/MMR Post-index Date Among Patients Without MR3/MMR Prior to Asciminib Initiation

    Time frame: From index date until the end of study period, up to 13 months

    MR3/MMR was defined as BCR::ABL1 less than or equal to 0.1%. Index date was defined as the date of initiation for asciminib.

  6. Number of Patients Without MR2 Prior to Asciminib Initiation who Achieved MR2 Post-index Date

    Time frame: Week 12, week 24 post-index date

    MR2 was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib.

  7. Median Time to MR2 Post-index Date Among Patients Without MR2 Prior to Asciminib Initiation

    Time frame: From index date until the end of study period, up to 13 months

    MR3/MMR was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib (ABL-2022-02)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

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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