CClinicalTrials.gg
CompletedNCT04089839Updated Jun 21, 2022

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

An observational study in Chronic Myeloid Leukemia, sponsored by Bristol-Myers Squibb. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
177
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 177 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients participating in an ongoing interventional trial
  • Patients diagnosed with AP-CML (accelerated phase) or BP-CML (blast phase)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
177 participants (actual)
Patient registry
No

Groups and cohorts

  • CP-CML participants initiating dasatinib

    Other: Non-Interventional

Interventions

  • OtherNon-Interventional

    Non-Interventional

06

What researchers measure

Primary outcomes

  1. Incidence of CP-CML patients remaining on dasatinib treatment

    Time frame: 24 months

Secondary outcomes

  1. Distribution of median age of CP-CML patients receiving dasatinib

    Time frame: 24 months

  2. Distribution of sex ratio of CP-CML patients receiving dasatinib

    Time frame: 24 months

  3. Distribution of concomitant treatment of CP-CML patients receiving dasatinib

    Time frame: 24 months

  4. Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib

    Time frame: 24 months

  5. Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib

    Time frame: 24 months

  6. Distribution of comorbidities of CP-CML patients receiving dasatinib

    Time frame: 24 months

  7. Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib

    Time frame: 24 months

  8. Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib

    Time frame: 24 months

  9. SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib

    Time frame: 24 months

  10. Distribution of prior treatment(s) of CP-CML patients receiving dasatinib

    Time frame: 24 months

  11. Incidence of initiating dasatinib due to suboptimal response

    Time frame: 24 months

  12. Incidence of initiating dasatinib due to failure

    Time frame: 24 months

  13. Incidence of initiating dasatinib due to intolerance

    Time frame: 24 months

  14. Incidence of initiating dasatinib due to convenience

    Time frame: 24 months

  15. Incidence of initiating dasatinib due to physician decision

    Time frame: 24 months

  16. Incidence of AE's

    Time frame: 24 months

  17. Incidence of SAE's

    Time frame: 24 months

  18. Utilization of dasatinib

    Time frame: 24 months

  19. Incidence of complete molecular response (CMR)

    Time frame: Up to 24 months

  20. Incidence of major molecular response (MMR)

    Time frame: Up to 24 months

07

Study locations

1 site
  • Local Institution
    Paris, 75002, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04089839
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 13, 2019
Start date
Apr 21, 2016
Primary completion
Jan 16, 2020
Completion
Jan 16, 2020
Last update
Jun 21, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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