Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Registration Number
- NCT06516029
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Eastern Cooperative Oncology Group Performance Score (ECOG-PS) at Index Date 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.Median Duration of Observation from Index Date to the end of the Study Period 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.
Age at Index Date Up to 137 months Index date was defined as the date of initiation for asciminib.
Number of Patients Categorized by the Five Most Common Baseline Comorbidities 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).
Number of Patients by Most Common Treatment Sequence From initial CML diagnosis until the end of study period, up to 143 months Gender at Index Date Up to 137 months Index date was defined as the date of initiation for asciminib.
Number of Patients by First Observed Line of Therapy with Asciminib at Index Date Up to 137 months Index date was defined as the date of initiation for asciminib.
Asciminib Treatment Persistence Rate Post-Index Date Week 12, week 24 post-index date Index date was defined as the date of initiation for asciminib.
Number of Patients Categorized by Last Molecular Response (MR) Achieved Within 3-months Prior to Index Date 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.Number of Patients by Status at End of First Observed Line of Therapy with Asciminib 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.Number of Patients by Type of TKI Received Immediately Before Asciminib Initiation Up to 137 months Race at Index Date Up to 137 months Index date was defined as the date of initiation for asciminib.
Type of Practice at Index Date Up to 137 months Types of practices included: community and academic practices. Index date was defined as the date of initiation for asciminib.
Number of Patients Categorized by Dosage of Asciminib at Index Date Up to 137 months Index date was defined as the date of initiation for asciminib.
Number of Patients by Type of First Tyrosine Kinase Inhibitor (TKI) Received Before Asciminib Initiation Up to 137 months Number of Patients by Type of TKI Received Anytime Before Asciminib Initiation Up to 137 months
- Secondary Outcome Measures
Name Time Method Median Time to MR3/MMR Post-index Date Among Patients Without MR3/MMR Prior to Asciminib Initiation 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.
Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR3/Major MR (MMR) 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.
Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR2 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.
Number of Patients Without MR3/MMR Prior to Asciminib Initiation who Achieved MR3/MMR Post-index Date 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.
Median Time to MR2 Post-index Date Among Patients Without MR2 Prior to Asciminib Initiation 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.
Number of Patients Without MR2 Prior to Asciminib Initiation who Achieved MR2 Post-index Date 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.
Number of Patients Categorized by Best Molecular Response (MR) Achieved Within 12-months Post-index Date 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.
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
šŗšøEast Hanover, New Jersey, United States