Clinical trial NCT06516029: Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib
Official title: Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib (ABL-2022-02)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia, Chronic Phase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


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.).

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).

Primary outcomes:
measure: Age at Index Date
timeFrame: Up to 137 months
measure: Gender at Index Date
timeFrame: Up to 137 months
measure: Race at Index Date
timeFrame: Up to 137 months
measure: Type of Practice at Index Date
timeFrame: Up to 137 months
measure: Eastern Cooperative Oncology Group Performance Score (ECOG-PS) at Index Date
timeFrame: Up to 137 months
measure: Number of Patients Categorized by the Five Most Common Baseline Comorbidities
timeFrame: Baseline
measure: Number of Patients Categorized by Last Molecular Response (MR) Achieved Within 3-months Prior to Index Date
timeFrame: Up to 3 months pre-index date
measure: Median Duration of Observation from Index Date to the end of the Study Period
timeFrame: Up to 13 months
measure: Number of Patients by First Observed Line of Therapy with Asciminib at Index Date
timeFrame: Up to 137 months
measure: Number of Patients Categorized by Dosage of Asciminib at Index Date
timeFrame: Up to 137 months
measure: Number of Patients by Status at End of First Observed Line of Therapy with Asciminib
timeFrame: From date of asciminib initiation to end of study period, up to 13 months
measure: Number of Patients by Type of First Tyrosine Kinase Inhibitor (TKI) Received Before Asciminib Initiation
timeFrame: Up to 137 months
measure: Number of Patients by Type of TKI Received Immediately Before Asciminib Initiation
timeFrame: Up to 137 months
measure: Number of Patients by Type of TKI Received Anytime Before Asciminib Initiation
timeFrame: Up to 137 months
measure: Number of Patients by Most Common Treatment Sequence
timeFrame: From initial CML diagnosis until the end of study period, up to 143 months
measure: Asciminib Treatment Persistence Rate Post-Index Date
timeFrame: Week 12, week 24 post-index date
Secondary outcomes:
measure: Number of Patients Categorized by Best Molecular Response (MR) Achieved Within 12-months Post-index Date
timeFrame: 12 months post-index date
measure: Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR3/Major MR (MMR)
timeFrame: Week 12, week 24 post-index date
measure: Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR2
timeFrame: Week 12, week 24 post-index date
measure: Number of Patients Without MR3/MMR Prior to Asciminib Initiation who Achieved MR3/MMR Post-index Date
timeFrame: Week 12, week 24 post-index date
measure: Median Time to MR3/MMR Post-index Date Among Patients Without MR3/MMR Prior to Asciminib Initiation
timeFrame: From index date until the end of study period, up to 13 months
measure: Number of Patients Without MR2 Prior to Asciminib Initiation who Achieved MR2 Post-index Date
timeFrame: Week 12, week 24 post-index date
measure: Median Time to MR2 Post-index Date Among Patients Without MR2 Prior to Asciminib Initiation
timeFrame: From index date until the end of study period, up to 13 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: