Chronic Myeloid Leukemia, Chronic PhaseNCT06516029
Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib
An observational study of Chronic Myeloid Leukemia, Chronic Phase, run by Novartis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2023to 2 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- 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.).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib (ABL-2022-02)
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
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overall Asciminib Cohort | Adult patients diagnosed with Ph+ CML-CP, with or without the T3151 mutation, who initiated asciminib in any line of therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at Index Date
Index date was defined as the date of initiation for asciminib.
Measured: Up to 137 months
Gender at Index Date
Index date was defined as the date of initiation for asciminib.
Measured: Up to 137 months
Race at Index Date
Index date was defined as the date of initiation for asciminib.
Measured: Up to 137 months
Type of Practice at Index Date
Types of practices included: community and academic practices. Index date was defined as the date of initiation for asciminib.
Measured: Up to 137 months
Eastern Cooperative Oncology Group Performance Score (ECOG-PS) at Index Date
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.
Measured: Up to 137 months
Number of Patients Categorized by the Five Most Common Baseline Comorbidities
Baseline was defined as the time between the date of initial CML diagnosis up to (and excluding) the date of asciminib initiation (index date).
Measured: Baseline
Number of Patients Categorized by Last Molecular Response (MR) Achieved Within 3-months Prior to 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.
Measured: Up to 3 months pre-index date
Median Duration of Observation from Index Date to the end of the Study Period
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.
Measured: Up to 13 months
Number of Patients by First Observed Line of Therapy with Asciminib at Index Date
Index date was defined as the date of initiation for asciminib.
Measured: Up to 137 months
Number of Patients Categorized by Dosage of Asciminib at Index Date
Index date was defined as the date of initiation for asciminib.
Measured: Up to 137 months
Number of Patients by Status at End of First Observed Line of Therapy with Asciminib
Status:
- Continued asciminib treatment (included dose change/held).
- Discontinued asciminib treatment.
Measured: From date of asciminib initiation to end of study period, up to 13 months
Number of Patients by Type of First Tyrosine Kinase Inhibitor (TKI) Received Before Asciminib Initiation
Measured: Up to 137 months
Number of Patients by Type of TKI Received Immediately Before Asciminib Initiation
Measured: Up to 137 months
Number of Patients by Type of TKI Received Anytime Before Asciminib Initiation
Measured: Up to 137 months
Number of Patients by Most Common Treatment Sequence
Measured: From initial CML diagnosis until the end of study period, up to 143 months
Asciminib Treatment Persistence Rate Post-Index Date
Index date was defined as the date of initiation for asciminib.
Measured: Week 12, week 24 post-index date
Secondary outcomes (7)
Number of Patients Categorized by Best Molecular Response (MR) Achieved Within 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.
Measured: 12 months post-index date
Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR3/Major MR (MMR)
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.
Measured: Week 12, week 24 post-index date
Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR2
MR2 was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib.
Measured: Week 12, week 24 post-index date
Number of Patients Without MR3/MMR Prior to Asciminib Initiation who Achieved MR3/MMR 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.
Measured: Week 12, week 24 post-index date
Median Time to MR3/MMR Post-index Date Among Patients Without MR3/MMR Prior to Asciminib Initiation
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.
Measured: From index date until the end of study period, up to 13 months
Number of Patients Without MR2 Prior to Asciminib Initiation who Achieved MR2 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.
Measured: Week 12, week 24 post-index date
Median Time to MR2 Post-index Date Among Patients Without MR2 Prior to Asciminib Initiation
MR3/MMR was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib.
Measured: From index date until the end of study period, up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start21 Apr 2023
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia, Chronic PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516029
- Sponsor's protocol ID
- CABL001A0US03
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib (ABL-2022-02)
- ClinicalTrials.gov ID
- NCT06516029
- Acronym / sponsor ID
- CABL001A0US03
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Asciminib Cohort | – | –Adult patients diagnosed with Ph+ CML-CP, with or without the T3151 mutation, who initiated asciminib in any line of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age at Index Date
Time frame: Up to 137 months
Index date was defined as the date of initiation for asciminib.
Gender at Index Date
Time frame: Up to 137 months
Index date was defined as the date of initiation for asciminib.
Race at Index Date
Time frame: Up to 137 months
Index date was defined as the date of initiation for asciminib.
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.
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.
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).
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.
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.
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.
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.
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.
Number of Patients by Type of First Tyrosine Kinase Inhibitor (TKI) Received Before Asciminib Initiation
Time frame: Up to 137 months
Number of Patients by Type of TKI Received Immediately Before Asciminib Initiation
Time frame: Up to 137 months
Number of Patients by Type of TKI Received Anytime Before Asciminib Initiation
Time frame: Up to 137 months
Number of Patients by Most Common Treatment Sequence
Time frame: From initial CML diagnosis until the end of study period, up to 143 months
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.
7 secondary outcomes
Number of Patients Categorized by Best Molecular Response (MR) Achieved Within 12-months Post-index Date
Time frame: 12 months post-index date
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
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
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
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
Number of Patients Without MR2 Prior to Asciminib Initiation who Achieved MR2 Post-index Date
Time frame: Week 12, week 24 post-index date
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, Chronic Phase, run by Novartis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at Index Date (time frame: Up to 137 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.