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

NCT ID: NCT06516029

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2023-10-02

Brief Summary

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.

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Overall Asciminib Cohort

Adult patients diagnosed with Ph+ CML-CP, with or without the T3151 mutation, who initiated asciminib in any line of therapy.

No interventions assigned to this group

Eligibility Criteria

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.).

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CABL001A0US03

Identifier Type: -

Identifier Source: org_study_id