Study Conducted Among Patients With CML
Study Details
Study Description
Brief Summary
Retrospective, non-interventional observational cohort study conducted among patients with CML.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| First-line Therapy 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.
|
| Second-line Therapy 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.
|
| Third-line Therapy 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.
|
| Fourth-line Therapy 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.
|
Outcome Measures
Primary Outcome Measures
- Number of patients across all lines of therapy [throughout the study, approximately 20 years]
Number of patients across all lines of therapy were reported to evaluate treatment sequences among the patients.
- Number of patients with the use of pre-treatment hydroxyurea [throughout the study, approximately 20 years]
Number of patients with the use of pre-treatment hydroxyurea were reported to evaluate treatment patterns in patients.
- Number of patients Treatment received and initial dose at each line [throughout the study, approximately 20 years]
Number of patients Treatment received and initial dose at each line were reported to evaluate treatment patterns in patients.
- Number of patients as per the calendar year of line of therapy initiation [throughout the study, approximately 20 years]
Number of patients as per the calendar year of line of therapy initiation were reported to evaluate treatment patterns in patients.
- Duration of the line of therapy [throughout the study, approximately 20 years]
Duration of the line of therapy was reported to evaluate treatment patterns in patients.
- Treatment-free period among those with an observed subsequent line of therapy [throughout the study, approximately 20 years]
Treatment-free period among those with an observed subsequent line of therapy was reported to evaluate treatment patterns in patients.
- Number of patients who discontinued treatment [throughout the study, approximately 20 years]
Number of patients who discontinued treatment were reported to evaluate treatment patterns in patients.
- Number of patients: All cause Health Resource Utilization among patients with three lines of therapy or more [throughout the study, approximately 20 years]
Number of patients: All cause Health Resource Utilization were reported to estimate HRU among patients with three lines of therapy or more.
- Healthcare costs among patients with three lines of therapy or more [throughout the study, approximately 20 years]
Healthcare costs among patients with three lines of therapy or more were reported.
Secondary Outcome Measures
- Prevalence of second and third or later lines of therapy [Calendar year 2006 to 2018, approximately 12 years]
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
- Healthcare costs among patients with earlier lines of therapy [throughout the study, approximately 20 years]
Healthcare costs among patients with earlier lines of therapy were reported.
- Number of patients: All cause Health Resource Utilization among patients with earlier lines of therapy [throughout the study, approximately 20 years]
Number of patients: All cause Health Resource Utilization among patients with earlier lines of therapy were reported.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | East Hanover | New Jersey | United States | 07936-1080 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CABL001AUS07