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NCT02363868 Clinical Trial

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
Secondary ID
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

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
See also
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Active, not recruiting NCT03746054 - Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality Phase 3
Completed NCT01667133 - A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) Phase 1/Phase 2
Completed NCT00720785 - Natural Killer Cells and Bortezomib to Treat Cancer Phase 1
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