A Study of Dasatinib Management Among CP-CML (Chronic Phase, Chronic Myeloid Leukemia) Participants Initiating Dasatinib in a Real Life Setting

Chronic Myeloid Leukemia Clinical Trial

Official title:

Prospective Assessment of Dasatinib Management Among CP-CML Patients With Dasatinib Initiation in a Real Life Setting: DasaREALISE.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089839
• Other study ID #: CA180-616
• Status: Completed
• Start date: April 21, 2016
• Est. completion date: January 16, 2020

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
France	Local Institution	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CP-CML patients remaining on dasatinib treatment		24 months
Secondary	Distribution of median age of CP-CML patients receiving dasatinib		24 months
Secondary	Distribution of sex ratio of CP-CML patients receiving dasatinib		24 months
Secondary	Distribution of concomitant treatment of CP-CML patients receiving dasatinib		24 months
Secondary	Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib		24 months
Secondary	Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib		24 months
Secondary	Distribution of comorbidities of CP-CML patients receiving dasatinib		24 months
Secondary	Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib		24 months
Secondary	Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib		24 months
Secondary	SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib		24 months
Secondary	Distribution of prior treatment(s) of CP-CML patients receiving dasatinib		24 months
Secondary	Incidence of initiating dasatinib due to suboptimal response		24 months
Secondary	Incidence of initiating dasatinib due to failure		24 months
Secondary	Incidence of initiating dasatinib due to intolerance		24 months
Secondary	Incidence of initiating dasatinib due to convenience		24 months
Secondary	Incidence of initiating dasatinib due to physician decision		24 months
Secondary	Incidence of AE's		24 months
Secondary	Incidence of SAE's		24 months
Secondary	Utilization of dasatinib		24 months
Secondary	Incidence of complete molecular response (CMR)		Up to 24 months
Secondary	Incidence of major molecular response (MMR)		Up to 24 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls