NCT05611216

Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation

Assessing Real-world Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation in the United States (ARC Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study was a retrospective, non-interventional patient chart review and used a panel of oncologists/hematologists from the US to collect real-world clinical outcomes of patients with CML-CP in 3L+ and those with the T315I mutation.

Detailed description

This study included two distinct cohorts of CML-CP patients; that is, patients with CML-CP who initiated 3L for CML-CP (i.e., 3L cohort) and patients with CML-CP with T315I mutation (i.e., T315I cohort). Study design for the analyses of the 3L cohort: * The index date: date of initiation of 3L therapy for CML-CP * The study period: period of ≥ 24 months following the index date unless the patient died before * Patient characteristics were measured at CML diagnosis and at the index date * The clinical outcomes of interest were measured during the study period Study design for the analyses of the T315I cohort: * The index date: date of initiation of a line of therapy identified as the T315I line of interest (i.e., identification of T315I mutation before initiation or over the course of line of therapy) * The study period: period of ≥ 24 months following the index date unless the patient died before * Patient characteristics were measured at CML diagnosis and at the index date. * The clinical outcomes of interest were measured during the study period

Conditions

• Chronic Myeloid Leukemia

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2022-11-09
• Last updated: 2023-04-06

Locations

1 site across 1 country: United States