A Study of Dasatinib Management Among CP-CML (Chronic Phase, Chronic Myeloid Leukemia) Participants Initiating Dasatinib in a Real Life Setting
Completed
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT04089839
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CP-CML participants initiating dasatinib Non-Interventional -
- Primary Outcome Measures
Name Time Method Incidence of CP-CML patients remaining on dasatinib treatment 24 months
- Secondary Outcome Measures
Name Time Method Distribution of sex ratio of CP-CML patients receiving dasatinib 24 months Distribution of median age of CP-CML patients receiving dasatinib 24 months Distribution of concomitant treatment of CP-CML patients receiving dasatinib 24 months Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib 24 months Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib 24 months SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib 24 months Distribution of prior treatment(s) of CP-CML patients receiving dasatinib 24 months Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib 24 months Distribution of comorbidities of CP-CML patients receiving dasatinib 24 months Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib 24 months Incidence of initiating dasatinib due to failure 24 months Incidence of initiating dasatinib due to suboptimal response 24 months Incidence of initiating dasatinib due to convenience 24 months Incidence of initiating dasatinib due to intolerance 24 months Incidence of initiating dasatinib due to physician decision 24 months Incidence of AE's 24 months Incidence of SAE's 24 months Utilization of dasatinib 24 months Incidence of complete molecular response (CMR) Up to 24 months Incidence of major molecular response (MMR) Up to 24 months
Trial Locations
- Locations (1)
Local Institution
🇫🇷Paris, France