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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04089839

Enrollment

177

Registered

2019-09-13

Start date

2016-04-21

Completion date

2020-01-16

Last updated

2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

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.

Interventions

OTHERNon-Interventional

Non-Interventional

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Distribution of median age of CP-CML patients receiving dasatinib	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
Incidence of initiating dasatinib due to suboptimal response	24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026