Study Conducted Among Patients With CML

Chronic Myeloid Leukemia Clinical Trial

Official title:

Real-World Treatment Patterns, Healthcare Resource Utilization and Associated Costs Among Patients With Chronic Myeloid Leukemia in Later Lines of Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476562
• Other study ID #: CABL001AUS07
• Status: Completed
• Start date: March 8, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective, non-interventional observational cohort study conducted among patients with CML.

Description:

A retrospective, non-interventional cohort study was used to address the study objectives. A cohort of adult patients with CML who were treated with TKIs were identified using the IBM® MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan database) to have a better understanding of real-world treatment patterns, HRU and healthcare costs among patients with CML treated with later lines of therapy (i.e., third line or later). For Phase I, the IBM® MarketScan® Commercial Claims and Encounters and Medicare Supplemental Databases were used (commercial claims). The commercial claims covered the period from 01/01/2001 to 06/30/2019. The study consisted of the following periods: - The baseline period was defined as the 6-month period before the first line therapy initiation for CML. - The observation period was defined as the period of at least 12 months from the first CML diagnosis to the end of data availability or end of health plan coverage, whichever occurs first; the observation period varied by patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3234
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Patients were selected for the analysis of later lines of therapy in commercial claims (i.e., were previously treated with TKIs, who are relapsed/refractory to/intolerant of

TKIs) if they met the following criteria:

• Had at least one diagnosis for CML, with first CML diagnosis observed in claims on or after May 10, 2001, the date of FDA approval for imatinib
• Were at least 18 years of age as of the first CML diagnosis
• Started a first line therapy for CML with imatinib, dasatinib, nilotinib, or bosutinib (conditional on FDA-approval dates)
• Initiated first line therapy within a maximum of 1 month prior to the first diagnosis for CML or a maximum 3 months following the first diagnosis for CML
• Had continuous health plan enrollment (pharmacy and medical benefits) from the washout period to at least 12 months following the first CML diagnosis

Exclusion Criteria:

• Patients had a diagnosis for CML remission or relapse anytime prior to first line therapy
• Patients had a medical claim associated with a clinical trial during the washout period up to the end of the observation period
• Patients had an HSCT during the washout period up to the first line therapy initiation
• Patients had chemotherapy treatment (except hydroxyurea) during the washout period up to the first line therapy initiation

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• Tyrosine Kinase Inhibitors (TKIs)
The study included patients with CML who were previously treated with TKIs, who are relapsed/refractory to/intolerant of TKIs on third or later lines of therapy in the US.

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients across all lines of therapy	Number of patients across all lines of therapy were reported to evaluate treatment sequences among the patients.	throughout the study, approximately 20 years
Primary	Number of patients with the use of pre-treatment hydroxyurea	Number of patients with the use of pre-treatment hydroxyurea were reported to evaluate treatment patterns in patients.	throughout the study, approximately 20 years
Primary	Number of patients Treatment received and initial dose at each line	Number of patients Treatment received and initial dose at each line were reported to evaluate treatment patterns in patients.	throughout the study, approximately 20 years
Primary	Number of patients as per the calendar year of line of therapy initiation	Number of patients as per the calendar year of line of therapy initiation were reported to evaluate treatment patterns in patients.	throughout the study, approximately 20 years
Primary	Duration of the line of therapy	Duration of the line of therapy was reported to evaluate treatment patterns in patients.	throughout the study, approximately 20 years
Primary	Treatment-free period among those with an observed subsequent line of therapy	Treatment-free period among those with an observed subsequent line of therapy was reported to evaluate treatment patterns in patients.	throughout the study, approximately 20 years
Primary	Number of patients who discontinued treatment	Number of patients who discontinued treatment were reported to evaluate treatment patterns in patients.	throughout the study, approximately 20 years
Primary	Number of patients: All cause Health Resource Utilization among patients with three lines of therapy or more	Number of patients: All cause Health Resource Utilization were reported to estimate HRU among patients with three lines of therapy or more.	throughout the study, approximately 20 years
Primary	Healthcare costs among patients with three lines of therapy or more	Healthcare costs among patients with three lines of therapy or more were reported.	throughout the study, approximately 20 years
Secondary	Prevalence of second and third or later lines of therapy	Prevalence was defined as the number of cases alive per year of patients with CML who were currently or previously treated on later lines of therapy (third line or later), by calendar year from 2006 to 2018	Calendar year 2006 to 2018, approximately 12 years
Secondary	Healthcare costs among patients with earlier lines of therapy	Healthcare costs among patients with earlier lines of therapy were reported.	throughout the study, approximately 20 years
Secondary	Number of patients: All cause Health Resource Utilization among patients with earlier lines of therapy	Number of patients: All cause Health Resource Utilization among patients with earlier lines of therapy were reported.	throughout the study, approximately 20 years

External Links

•   Results for CABL001AUS07 from the Novartis Clinical Trials Website