Treatment Patterns and Key Endpoints Among Patients With Chronic-Phase Chronic Myeloid Leukemia in a Community Oncology Setting

Novartis

Status: Completed

Conditions: Leukemia, Myeloid, Chronic-Phase

Study type: Observational

Funder types: Industry

Identifiers

NCT07374120

CABL001A0US12

Details and patient eligibility

About

This was a retrospective observational study to examine treatment patterns, molecular testing patterns, treatment response, and clinical outcomes among patients initiating first-line (1L) tyrosine kinase inhibitor (TKI) treatment for CML-CP in The United States (US) Oncology Network practices.

Patients who initiated 1L therapy between 01 January 2016 and 31 December 2022 were eligible for inclusion in the study. Study-eligible patients were followed longitudinally post-index until death (if the patient had documentation of death during the study observation period) or last available patient record that occurred on or before the end of the study observation period. The study observation period was from 01 January 2016 to 30 November 2023. The index date was defined as the start date of 1L therapy for CML-CP.

Enrollment: 1,480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients whose data were accessible for research purposes during the study observation period.
2. Patients diagnosed with CML-CP at first recorded diagnosis of CML.
3. Patients ≥ 18 years of age at first recorded diagnosis of CML.
4. Patients who initiated qualifying 1L therapy for CML-CP during the study identification period. Qualifying 1L therapy treatments consisted of imatinib, dasatinib, bosutinib, or nilotinib as monotherapy.
5. Patients with ≥1 visit within The US Oncology Network practices following initiation of 1L therapy and through the end of the study observation period.

Exclusion criteria

1. Patients enrolled in interventional clinical trials during the study observation period.
2. Patients who received any systemic treatment indicated for another primary cancer during the study observation period.

Trial design

1,480 participants in 1 patient group

CML-CP Group

Description:

Patients with a diagnosis of CML-CP who initiated 1L TKI treatment in The US Oncology Network practices between 01 January 2016 and 31 December 2022.