An observational study in Chronic Myeloid Leukemia, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
Retrospective, non-interventional observational cohort study conducted among patients with CML.
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:
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 3,234 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study was conducted among patients with CML.
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:
Exclusion Criteria:
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)
Other: Tyrosine Kinase Inhibitors (TKIs)
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)
Other: Tyrosine Kinase Inhibitors (TKIs)
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)
Other: Tyrosine Kinase Inhibitors (TKIs)
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)
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.
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.
Time frame: throughout the study, approximately 20 years
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.
Time frame: throughout the study, approximately 20 years
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.
Time frame: throughout the study, approximately 20 years
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.
Time frame: throughout the study, approximately 20 years
Duration of the line of therapy
Duration of the line of therapy was reported to evaluate treatment patterns in patients.
Time frame: throughout the study, approximately 20 years
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.
Time frame: throughout the study, approximately 20 years
Number of patients who discontinued treatment
Number of patients who discontinued treatment were reported to evaluate treatment patterns in patients.
Time frame: throughout the study, approximately 20 years
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.
Time frame: throughout the study, approximately 20 years
Healthcare costs among patients with three lines of therapy or more
Healthcare costs among patients with three lines of therapy or more were reported.
Time frame: throughout the study, approximately 20 years
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
Time frame: Calendar year 2006 to 2018, approximately 12 years
Healthcare costs among patients with earlier lines of therapy
Healthcare costs among patients with earlier lines of therapy were reported.
Time frame: throughout the study, approximately 20 years
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.
Time frame: throughout the study, approximately 20 years
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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