NCT02363868

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

February 10, 2015

Last Update Submit

July 3, 2015

Conditions

Chronic Myeloid Leukemia (CML)

Outcome Measures

Primary Outcomes (1)

  • Healthcare costs

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

    Intent-to-treat (ITT) at 6 months

Secondary Outcomes (2)

  • Healthcare costs by line of therapy

    Intent-to-treat (ITT) at 6 months

  • Resource utilization by line of therapy

    Intent-to-treat (ITT) at 6 months

Study Arms (2)

CML subjects receiving Dasatinib

CML receiving dasatinib as first or second line therapy will be conducted to assess healthcare costs

CML subjects receiving Nilotinib

CML receiving nilotinib as first or second line therapy will be conducted to assess healthcare costs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Others: Retrospecitve database analysis of patients in a health plan

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin Pharmaceutical Consulting, Llc

Clinton, South Carolina, 29325, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 16, 2015

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

US(1)