Clinical trial NCT04089839: A Study of Dasatinib Management Among CP-CML (Chronic Phase, Chronic Myeloid Leukemia) Participants Initiating Dasatinib in a Real Life Setting
Official title: Prospective Assessment of Dasatinib Management Among CP-CML Patients With Dasatinib Initiation in a Real Life Setting: DasaREALISE.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients participating in an ongoing interventional trial
* Patients diagnosed with AP-CML (accelerated phase) or BP-CML (blast phase)

Primary outcomes:
measure: Incidence of CP-CML patients remaining on dasatinib treatment
timeFrame: 24 months
Secondary outcomes:
measure: Distribution of median age of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution of sex ratio of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution of concomitant treatment of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution of comorbidities of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Distribution of prior treatment(s) of CP-CML patients receiving dasatinib
timeFrame: 24 months
measure: Incidence of initiating dasatinib due to suboptimal response
timeFrame: 24 months
measure: Incidence of initiating dasatinib due to failure
timeFrame: 24 months
measure: Incidence of initiating dasatinib due to intolerance
timeFrame: 24 months
measure: Incidence of initiating dasatinib due to convenience
timeFrame: 24 months
measure: Incidence of initiating dasatinib due to physician decision
timeFrame: 24 months
measure: Incidence of AE's
timeFrame: 24 months
measure: Incidence of SAE's
timeFrame: 24 months
measure: Utilization of dasatinib
timeFrame: 24 months
measure: Incidence of complete molecular response (CMR)
timeFrame: Up to 24 months
measure: Incidence of major molecular response (MMR)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: