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

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.

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Key information

Conditions

Chronic Myeloid Leukemia (CML) Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Franklin Pharmaceutical Consulting, Llc

Clinton, South Carolina, 29325, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Healthcare costs

Time frame: Intent-to-treat (ITT) at 6 months

Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy

Secondary outcomes

Healthcare costs by line of therapy

Time frame: Intent-to-treat (ITT) at 6 months
Resource utilization by line of therapy

Time frame: Intent-to-treat (ITT) at 6 months

Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 16, 2015
Registry last updated: Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed