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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04089839
Collaborator
(none)
177
Enrollment
1
Location
44.8
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-Interventional

Study Design

Study Type:
Observational
Actual Enrollment :
177 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Assessment of Dasatinib Management Among CP-CML Patients With Dasatinib Initiation in a Real Life Setting: DasaREALISE.
Actual Study Start Date :
Apr 21, 2016
Actual Primary Completion Date :
Jan 16, 2020
Actual Study Completion Date :
Jan 16, 2020

Arms and Interventions

Arm Intervention/Treatment
CP-CML participants initiating dasatinib

Other: Non-Interventional
Non-Interventional

Outcome Measures

Primary Outcome Measures

  1. Incidence of CP-CML patients remaining on dasatinib treatment [24 months]

Secondary Outcome Measures

  1. Distribution of median age of CP-CML patients receiving dasatinib [24 months]

  2. Distribution of sex ratio of CP-CML patients receiving dasatinib [24 months]

  3. Distribution of concomitant treatment of CP-CML patients receiving dasatinib [24 months]

  4. Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib [24 months]

  5. Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib [24 months]

  6. Distribution of comorbidities of CP-CML patients receiving dasatinib [24 months]

  7. Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib [24 months]

  8. Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib [24 months]

  9. SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib [24 months]

  10. Distribution of prior treatment(s) of CP-CML patients receiving dasatinib [24 months]

  11. Incidence of initiating dasatinib due to suboptimal response [24 months]

  12. Incidence of initiating dasatinib due to failure [24 months]

  13. Incidence of initiating dasatinib due to intolerance [24 months]

  14. Incidence of initiating dasatinib due to convenience [24 months]

  15. Incidence of initiating dasatinib due to physician decision [24 months]

  16. Incidence of AE's [24 months]

  17. Incidence of SAE's [24 months]

  18. Utilization of dasatinib [24 months]

  19. Incidence of complete molecular response (CMR) [Up to 24 months]

  20. Incidence of major molecular response (MMR) [Up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Local Institution Paris France 75002

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04089839
Other Study ID Numbers:
  • CA180-616
First Posted:
Sep 13, 2019
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Jun 21, 2022