Study Conducted Among Patients With CML

NCT05476562 | Completed

• 1 other identifier: CABL001AUS07
• Study Type: observational
• Target: 3,234
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemia,; tyrosine kinase inhibitors,; treatment patterns,; HRU,; costs

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Prevalence of second and third or later lines of therapy

  Calendar year 2006 to 2018, approximately 12 years

• Healthcare costs 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

  throughout the study, approximately 20 years

Study Arms (4)

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)

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)

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)

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)

Interventions

Tyrosine Kinase Inhibitors (TKIs) OTHER

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.

First-line Therapy; Fourth-line Therapy; Second-line Therapy; Third-line Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted among patients with CML.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CABL001AUS07 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Tyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: March 8, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

US (1)