Chronic Myeloid LeukemiaNCT04089839
A Study of Dasatinib Management Among CP-CML (Chronic Phase, Chronic Myeloid Leukemia) Participants Initiating Dasatinib in a Real Life Setting
An observational study of Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 1 site in France.
Trial summary
This is a prospective, non-interventional study conducted in CP-CML patients receiving dasatinib who are enrolled by a sample of hematologists in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Non-Interventional
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2016to 16 Jan 2020
- 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: All French hematologists will be invited to participate to the study, and the study will be conducted by hematologists agreeing to participate. Each participating investigator will need to enroll consecutive CP-CML patients who meet the selection criteria.
Who may be able to join
- Patients aged greater than or equal to 18 years
- Patients diagnosed with CP-CML
- Patients who started dasatinib within the last month before inclusion, or on the day of inclusion or within the month after inclusion
Who cannot join
- Patients participating in an ongoing interventional trial
- Patients diagnosed with AP-CML (accelerated phase) or BP-CML (blast phase)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Assessment of Dasatinib Management Among CP-CML Patients With Dasatinib Initiation in a Real Life Setting: DasaREALISE.
This is a prospective, non-interventional study conducted in CP-CML patients receiving dasatinib who are enrolled by a sample of hematologists in France.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Non-Interventional
- 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.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| CP-CML participants initiating dasatinib | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CP-CML patients remaining on dasatinib treatment
Measured: 24 months
Secondary outcomes (20)
Distribution of median age of CP-CML patients receiving dasatinib
Measured: 24 months
Distribution of sex ratio of CP-CML patients receiving dasatinib
Measured: 24 months
Distribution of concomitant treatment of CP-CML patients receiving dasatinib
Measured: 24 months
Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib
Measured: 24 months
Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib
Measured: 24 months
Distribution of comorbidities of CP-CML patients receiving dasatinib
Measured: 24 months
Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib
Measured: 24 months
Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib
Measured: 24 months
SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib
Measured: 24 months
Distribution of prior treatment(s) of CP-CML patients receiving dasatinib
Measured: 24 months
Incidence of initiating dasatinib due to suboptimal response
Measured: 24 months
Incidence of initiating dasatinib due to failure
Measured: 24 months
Incidence of initiating dasatinib due to intolerance
Measured: 24 months
Incidence of initiating dasatinib due to convenience
Measured: 24 months
Incidence of initiating dasatinib due to physician decision
Measured: 24 months
Incidence of AE's
Measured: 24 months
Incidence of SAE's
Measured: 24 months
Utilization of dasatinib
Measured: 24 months
Incidence of complete molecular response (CMR)
Measured: Up to 24 months
Incidence of major molecular response (MMR)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start21 Apr 2016
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies 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
- Prospective
- Enrolment
- 177 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
- NCT04089839
- Sponsor's protocol ID
- CA180-616
- Status last verified
- Jun 2022
- First submitted
- 8 Jan 2019
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Dasatinib Management Among CP-CML Patients With Dasatinib Initiation in a Real Life Setting: DasaREALISE.
- ClinicalTrials.gov ID
- NCT04089839
- Acronym / sponsor ID
- CA180-616
- Conditions
- Chronic Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 13 Sep 2019 (actual)
- 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.
This is a prospective, non-interventional study conducted in CP-CML patients receiving dasatinib who are enrolled by a sample of hematologists in France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CP-CML participants initiating dasatinib | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All French hematologists will be invited to participate to the study, and the study will be conducted by hematologists agreeing to participate. Each participating investigator will need to enroll consecutive CP-CML patients who meet the selection criteria.
Key inclusion criteria (3 listed)
- Patients aged greater than or equal to 18 years
- Patients diagnosed with CP-CML
- Patients who started dasatinib within the last month before inclusion, or on the day of inclusion or within the month after inclusion
Key exclusion criteria (2 listed)
- Patients participating in an ongoing interventional trial
- Patients diagnosed with AP-CML (accelerated phase) or BP-CML (blast phase)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | CP-CML participants initiating dasatinib |
Primary outcome
Incidence of CP-CML patients remaining on dasatinib treatment
Time frame: 24 months
20 secondary outcomes
Distribution of median age of CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution of sex ratio of CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution of concomitant treatment of CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution of comorbidities of CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib
Time frame: 24 months
SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib
Time frame: 24 months
Distribution of prior treatment(s) of CP-CML patients receiving dasatinib
Time frame: 24 months
Incidence of initiating dasatinib due to suboptimal response
Time frame: 24 months
Incidence of initiating dasatinib due to failure
Time frame: 24 months
Incidence of initiating dasatinib due to intolerance
Time frame: 24 months
Incidence of initiating dasatinib due to convenience
Time frame: 24 months
Incidence of initiating dasatinib due to physician decision
Time frame: 24 months
Incidence of AE's
Time frame: 24 months
Incidence of SAE's
Time frame: 24 months
Utilization of dasatinib
Time frame: 24 months
Incidence of complete molecular response (CMR)
Time frame: Up to 24 months
Incidence of major molecular response (MMR)
Time frame: Up to 24 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 21 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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, run by Bristol-Myers Squibb at 1 site in France.
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 3 inclusion and 2 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 21 Jun 2022. 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 France. 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?
Incidence of CP-CML patients remaining on dasatinib treatment (time frame: 24 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 21 Jun 2022.