Real-World Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia in Earlier Lines of Therapy (ABL-2022-03)

Novartis

Status: Completed

Conditions: Chronic Myeloid Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT06692803

CABL001A0US04

Details and patient eligibility

About

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).

Enrollment: 2,043 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

2,043 participants in 2 patient groups

First Treatment Cohort

Description:

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

Second Treatment Cohort

Description:

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