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

NCT06692803 | Completed

• 1 other identifier: CABL001A0US04
• Study Type: observational
• Target: 2,043
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Treatment Patterns

  Tyrosine kinase inhibitor (TKI) treatment management patterns in CML patients on first line or second line TKI were assessed.

  Up to approximately 10 years

Secondary Outcomes (17)

• Proportion of Days Covered (PDC)

  Up to approximately 10 years

• Number of Patients per PDC Category

  Up to approximately 10 years

• Time to Treatment Discontinuation

  Up to approximately 10 years

• Time to Treatment Switch

  Up to approximately 10 years

• Time to First Treatment Interruption

  Up to approximately 10 years

Study Arms (2)

First Treatment Cohort

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: May 23, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)