NCT04089839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

3.7 years

First QC Date

January 8, 2019

Last Update Submit

June 17, 2022

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of CP-CML patients remaining on dasatinib treatment

    24 months

Secondary Outcomes (20)

  • 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

  • +15 more secondary outcomes

Study Arms (1)

CP-CML participants initiating dasatinib

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

CP-CML participants initiating dasatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients aged greater than or equal to 18 years
  • Patients diagnosed with CP-CML

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Paris, 75002, France

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

September 13, 2019

Study Start

April 21, 2016

Primary Completion

January 16, 2020

Study Completion

January 16, 2020

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

FR(1)