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Completed

NCT Number: NCT04089839

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

This is a prospective, non-interventional study conducted in CP-CML patients receiving dasatinib who are enrolled by a sample of hematologists in France.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Paris, 75002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-Interventional

Other

Non-Interventional

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2019
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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