Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population

Chronic Myeloid Leukemia (CML) Clinical Trial

Official title:

Costs and Outcome Among Patients With Chronic Myelogenous Leukemia (CML) Receiving Dasatinib or Nilotinib as First or Second Line Therapy in a Commercial and Medicare Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363868
• Other study ID #: CA180-568
• Status: Completed
• Phase: N/A
• First received: February 10, 2015
• Last updated: July 3, 2015
• Start date: February 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the healthcare costs among patients with CML receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Age >18 years

• International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) code for CML (205.1x)

• At least 2 prescriptions for dasatinib or nilotinib from July 1, 2008 to June 31, 2013

• Continuous eligibility for the 6 months pre- and post-index date (defined as the date of first fill for dasatinib or nilotinib)

Exclusion Criteria:

• History of bone marrow or stem cell transplant as identified in the 6 month pre-period

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia (CML)
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Locations

Country	Name	City	State
United States	Franklin Pharmaceutical Consulting, Llc	Clinton	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare costs	Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy	Intent-to-treat (ITT) at 6 months	No
Secondary	Healthcare costs by line of therapy		Intent-to-treat (ITT) at 6 months	No
Secondary	Resource utilization by line of therapy	Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions	Intent-to-treat (ITT) at 6 months	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form