Real-World Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia in Earlier Lines of Therapy

NCT ID: NCT06692803

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2043 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2023-11-30

Brief Summary

This was a retrospective, non-interventional, observational cohort study using Optum's de-identified Clinformatics® Data Mart Database. Adult patients newly diagnosed with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) were identified using the Optum database and classified into the following cohorts:

• First treatment cohort: Patients newly diagnosed with CML who received first treatment with a TKI.
• Second treatment cohort: Patients from first treatment cohort with a subsequent line of therapy (i.e., second treatment) with a TKI.

The observation period spanned from the start of data availability (i.e., 01 January 2007) to the earliest of end of data (i.e., 30 June 2022), end of continuous health plan enrollment, or death (if available). The index date was defined as the first treatment initiation for the first treatment TKI cohort and as the second treatment initiation for the second treatment TKI cohort. The baseline period consisted of the 6 months prior to the index date. The follow-up period started on the index date and ended at the earliest of end of observation period or hematopoietic stem cell transplantation (HSCT).

Conditions

Chronic Myeloid Leukemia

Study Design

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

Study Groups

First Treatment Cohort

Patients newly diagnosed with CML who received first treatment with imatinib, dasatinib, nilotinib, or bosutinib.

No interventions assigned to this group

Second Treatment Cohort

Patients from first treatment cohort with a subsequent line of therapy (i.e., second treatment) with imatinib, dasatinib, nilotinib, bosutinib, or ponatinib.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adult patients who initiated their first treatment with imatinib, dasatinib, nilotinib, or bosutinib (conditional on Food and Drug Administration (FDA) approval dates) with 6 months continuous health plan enrollment prior to the first prescription fill date.
• Patients with 2 or more diagnoses for CML (adult as of the first diagnosis for CML).
• Patients had index date on or after first CML diagnosis.
• Patients had no diagnoses for CML remission/relapse prior to index date.
• Patients had no gastrointestinal stomach tumor (GIST) or chronic myelomonocytic leukemia (CMML) at any time.
• Patients had no medical claims associated with a clinical trial during the baseline period.
• Patients had no hematopoietic stem cell transplantation (HSCT) during the baseline period.
• Patients had no CML-related chemotherapy treatments for accelerated phase (AP)/blast crisis (BC) during the baseline period.
• First treatment cohort:

• Patients started first treatment for CML with imatinib, dasatinib, nilotinib, or bosutinib in 2012 or later.
• Patients had no HSCT during the first treatment baseline period.
• Patients had no CML-related chemotherapy treatment for AP/BC during the first treatment baseline period.
• Second treatment cohort:

• Patients started second treatment for CML with imatinib, dasatinib, nilotinib, or bosutinib in 2012 or later.
• Patients had no HSCT from the first treatment baseline period up to second treatment initiation.
• Patients had no CML-related chemotherapy treatment for AP/BC from the first treatment baseline period up to second treatment initiation.

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

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CABL001A0US04

Identifier Type: -

Identifier Source: org_study_id