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Leukemia, Chronic MyeloidNCT07188428

Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia (CML) in All Lines of Treatment

An observational study of Leukemia, Chronic Myeloid, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to evaluate the real-world treatment patterns, healthcare resource use and costs among patients newly diagnosed with CML who were treated with tyrosine kinase inhibitors (TKIs) in first- and second-line therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Chronic Myeloid
How many people
2,298 participants
Where
1 siteUnited States
Study dates
27 Feb 2024to 2 Dec 2024
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, non-interventional cohort study.

Who may be able to join

  • L Cohort:
  • Patients had at least one diagnosis for CML (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]: C92.1x) during the observation period.
  • Patients ≥18 years of age as of the first CML diagnosis.
  • Patients received imatinib, dasatinib, nilotinib, or bosutinib in 1L.
  • Patients initiated 1L within a maximum of 3 months following the first observed CML diagnosis.
  • Patients had at least 12 months of continuous enrollment prior to the index date.
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  • Patients had at least 6 months of continuous enrollment post index date (including index date).
  • L Cohort:
  • Patients in the 1L cohort.
  • Patients received imatinib, dasatinib, nilotinib, bosutinib, ponatinib or asciminib in 2L.
  • Patients with at least 12 months of continuous enrollment prior to the index date.
  • Patients with at least 6 months of continuous enrollment post index date (including index date).

Who cannot join

  • L Cohort:
  • Patients with medical services with a procedure code for imatinib any time during the observation period.
  • Patients with a diagnosis for CML remission (identified by ICD-10-CM code: C92.11) or CML relapse (ICD-10-CM code: C92.12) any time in the baseline period before the 1L initiation.
  • Patients with a medical claim associated with a clinical trial drug during the baseline period before the 1L initiation up to the end of the observation period.
  • Patients who received chemotherapy, or a TKI of interest or had a hematopoietic stem cell transplantation (HSCT) during the baseline period before 1L initiation.
  • L Cohort:
  • Patients with a diagnosis for CML remission (identified by ICD-10-CM code: C92.11) or CML relapse (ICD-10-CM code: C92.12) any time before the 2L initiation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Novartis

    East Hanover, New Jersey, 07936

Other trials in United States

About this study

Official title: Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia (CML) in All Lines of Therapy: An Analysis of Medicare Fee-for-Service (FFS) Data

The aim of this study was to evaluate the real-world treatment patterns, healthcare resource use and costs among patients newly diagnosed with CML who were treated with tyrosine kinase inhibitors (TKIs) in first- and second-line therapy.

Read the detailed description

The study used claims from Medicare FFS data from 1 January 2016 to 31 December 2022 (observation period). The patient identification period spanned from 1 January 2017 to 30 June 2022. The index date was the date of treatment line initiation. Patients were followed from index date until death, end of enrollment, or study end (31 December 2022), whichever came first. Each patient's follow-up was variable in length.

Variables were assessed during the follow-up period in first-line (1L) and second-line (2L) treatment cohorts and were stratified by generations of TKIs and treatment profiles. Patients were categorized into non-optimal treatment (NOPT) profiles and reference groups, and treatment patterns, healthcare resource utilization (HCRU), and payer healthcare costs were summarized descriptively for each group.

Keywords
Tyrosine kinase inhibitors, Treatment pattern, Non-optimal treatment profile
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07188428
Study groupRoleWhat they receive
1L CohortAdult patients newly diagnosed with CML who received 1L treatment with imatinib, dasatinib, nilotinib, or bosutinib.
2L CohortAdult patients from the 1L Cohort with a subsequent line of treatment (i.e., second treatment) with imatinib, dasatinib, nilotinib, bosutinib, ponatinib, or asciminib.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Who Switched to Another CML-related Treatment by TKI Generation and Treatment Profile

    Measured: Up to approximately 6 years

  2. Number of Patients Who Switched to Another CML-related Treatment Within 6 Months of Starting Treatment by TKI Generation and Treatment Profile

    Measured: 6 months

  3. Time to Treatment Switch by TKI Generation and Treatment Profile

    Measured: Up to approximately 6 years

Secondary outcomes (13)

  1. Proportion of Days Covered (PDC) by TKI Generation and Treatment Profile

    Adherence was assessed using PDC. The PDC was defined as the number of days of medication covered during the treatment line, divided by the number of calendar days between the start and end dates of the line of treatment.

    Measured: Up to approximately 6 years

  2. Number of Patients With PDC >80% by TKI Generation and Treatment Profile

    Adherence was assessed using PDC. The PDC was defined as the number of days of medication covered during the treatment line, divided by the number of calendar days between the start and end dates of the line of treatment.

    Measured: Up to approximately 6 years

  3. Number of Patients who Discontinued Treatment by TKI Generation and Treatment Profile

    Measured: Up to approximately 6 years

  4. Time to Treatment Discontinuation by TKI Generation and Treatment Profile

    Measured: Up to approximately 6 years

  5. Number of Patients With Treatment Interruption by TKI Generation and Treatment Profile

    Treatment interruption was defined as a gap of ≥14 days in CML treatment with resumption of that treatment after the gap.

    Measured: Up to approximately 6 years

  6. Time to First Treatment Interruption by TKI Generation and Treatment Profile

    Measured: Up to approximately 6 years

  7. Number of Patients With a Dose Reduction by TKI Generation and Treatment Profile

    Measured: Up to approximately 6 years

  8. Time to Dose Reduction by TKI Generation and Treatment Profile

    Measured: Up to approximately 6 years

  9. Mean Number of All-cause Healthcare Visits per Person per Year (PPPY) by Treatment Profile

    Healthcare visits included inpatient visits, outpatient visits, emergency department visits, and pharmacy visits.

    Measured: Up to approximately 6 years

  10. Mean Number of CML-related Healthcare Visits per Person per Year (PPPY) by Treatment Profile

    Healthcare visits included inpatient visits, outpatient visits, emergency department visits, and pharmacy visits.

    Measured: Up to approximately 6 years

  11. Mean Length of Stay (LoS) of Inpatient Visits PPPY by Treatment Profile

    Measured: Up to approximately 6 years

  12. Mean All-cause Healthcare Cost PPPY by Treatment Profile

    Healthcare costs included:

    • Total costs
    • Inpatient costs
    • Emergency department costs
    • Outpatient costs
    • Other costs
    • Pharmacy costs

    Measured: Up to approximately 6 years

  13. Mean CML-related Healthcare Cost PPPY by Treatment Profile

    Healthcare costs included:

    • Total costs
    • Inpatient costs
    • Emergency department costs
    • Outpatient costs
    • Other costs
    • Pharmacy costs

    Measured: Up to approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start27 Feb 2024
  3. Primary completion2 Dec 2024
  4. Study completion2 Dec 2024

Resources

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
2,298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07188428
Sponsor's protocol ID
CABL001A0US06
Status last verified
Sep 2025
First submitted
16 Sep 2025
Last updated
23 Sep 2025
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, Chronic Myeloid, run by Novartis Pharmaceuticals 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 12 inclusion and 7 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 Sep 2025. 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?

Number of Patients Who Switched to Another CML-related Treatment by TKI Generation and Treatment Profile (time frame: Up to approximately 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07188428.

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 Sep 2025.

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