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OpenTrials
Completed

NCT Number: NCT06211153

Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)

This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.

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Key information

Conditions

Chronic Myeloid Leukemia With T315I Mutation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Study Population: Key Inclusion/Exclusion Criteria Inclusion criteria

  • Diagnosis of CML (chronic phase, accelerated phase or blast crisis).
  • Confirmed presence of T315I mutation prior to asciminib initiation.
  • Patients enrolled in the asciminib MAP and received their first dose of asciminib between 01 November 2018 and 30 April 2022. Patients must have received at least one dose of asciminib.
  • Appropriate approval was obtained for the patient chart review including:
  • Patient signed the informed consent form (ICF) or,
  • Individual ICF waiver was granted by an institutional review board/ Independent Ethics Committee (IRB)/ IEC.

Exclusion criteria

  • Age less than 18 years old at the time of initiating asciminib treatment.

Treatment and study plan

Primary outcomes

  1. Major molecular response (MMR) at 6 months

    Time frame: At 6 months

  2. Major molecular response (MMR) by 6 months

    Time frame: By 6 months

Secondary outcomes

  1. MMR at and by 3, 9, and 12 months

    Time frame: At and by 3, 9, and 12 months

  2. Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months

    Time frame: At and by 3, 6, 9, and 12 months

  3. Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months

    Time frame: At and by 3, 6, 9, and 12 months

  4. Time to first CCyR at and by 3, 6, 9, and 12 months

    Time frame: At and by 3, 6, 9, and 12 months

  5. Gender

    Time frame: Baseline

  6. Race

    Time frame: Baseline

  7. Time from CML diagnosis to study index (i.e., asciminib) start date

    Time frame: Baseline

  8. Country of residence

    Time frame: Baseline

  9. Status of CML at baseline

    Time frame: Baseline

  10. Number of patients per response type at asciminib start date

    Time frame: Baseline

    Response types were MMR, CCyR, and CHR.

  11. Stem-cell transplant performed status

    Time frame: Baseline

  12. Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date

    Time frame: Baseline

  13. Overall tyrosine kinase inhibitors (TKIs) prior to index date

    Time frame: Baseline

  14. Prior TKIs between CML diagnosis and T315I mutation diagnosis

    Time frame: Baseline

  15. Prior TKIs between T315I mutation diagnosis and index date

    Time frame: Baseline

  16. Sequence of prior TKI treatment patterns

    Time frame: Baseline

  17. Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date)

    Time frame: Baseline

    Response types were MMR, CCyR, and CHR.

  18. Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis

    Time frame: Baseline

    Response types were MMR, CCyR, and CHR.

  19. Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date)

    Time frame: Baseline

    Response types were MMR, CCyR, and CHR.

  20. Number of patients with intolerance to prior TKIs, per category

    Time frame: Baseline

    Categories were discontinuation due to adverse events, relationship to treatment, and outcome.

  21. Number of patients with intolerance to last TKI prior to asciminib, per category

    Time frame: Baseline

    Categories were discontinuation due to adverse events, relationship to treatment, and outcome.

  22. Asciminib dose

    Time frame: Up to 13 months

  23. Asciminib discontinuation

    Time frame: Up to 13 months

  24. Duration of exposure to asciminib

    Time frame: Up to 13 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2024
Registry last updated
Jan 18, 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.