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Spots Global Cancer Trial Database for Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation

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Trial Identification

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

Official Title: 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)

Study ID: NCT05611216

Interventions

Study Description

Brief 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Novartis Investigative Site, East Hanover, New Jersey, United States

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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