Chronic Myeloid Leukemia (CML)NCT02363868
Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population
An observational study of Chronic Myeloid Leukemia (CML), run by Bristol-Myers Squibb at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Others: Retrospecitve database analysis of patients in a health plan
Who may be able to join
- 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)
Who cannot join
- History of bone marrow or stem cell transplant as identified in the 6 month pre-period
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Pharmaceutical Consulting, Llc
Clinton, South Carolina, 29325
About this study
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
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.
- Conditions
- Chronic Myeloid Leukemia (CML)
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare costs
Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy
Measured: Intent-to-treat (ITT) at 6 months
Secondary outcomes (2)
Healthcare costs by line of therapy
Measured: Intent-to-treat (ITT) at 6 months
Resource utilization by line of therapy
Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions
Measured: Intent-to-treat (ITT) at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363868
- Sponsor's protocol ID
- CA180-568
- Status last verified
- Jul 2015
- First submitted
- 10 Feb 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02363868
- Acronym / sponsor ID
- CA180-568
- Conditions
- Chronic Myeloid Leukemia (CML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Others: Retrospecitve database analysis of patients in a health plan
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- History of bone marrow or stem cell transplant as identified in the 6 month pre-period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healthcare costs
Time frame: Intent-to-treat (ITT) at 6 months
Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Related trials for Chronic Myeloid Leukemia (CML)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia (CML), run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare costs (time frame: Intent-to-treat (ITT) at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.