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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• France
  • Paris, France, 75002
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CP-CML participants initiating dasatinib	Other: Non-Interventional; Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of CP-CML patients remaining on dasatinib treatment	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Distribution of median age of CP-CML patients receiving dasatinib	24 months
Distribution of sex ratio 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 body mass index (BMI) of CP-CML patients receiving dasatinib	24 months
Distribution of comorbidities 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
Distribution disease characteristics of last known molecular response 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
Incidence of initiating dasatinib due to suboptimal response	24 months
Incidence of initiating dasatinib due to failure	24 months
Incidence of initiating dasatinib due to intolerance	24 months
Incidence of initiating dasatinib due to convenience	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2016
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): January 16, 2020

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: CA180-616

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No