NCT02546791

Brief Summary

This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include 100 patients treated in different public centers in the Mexican Republic.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

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

July 22, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

September 9, 2015

Last Update Submit

July 24, 2017

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • Detect the absence and presence of pleural effusion in Mexican patients measured from the medical records and databases of each of the participating medical centers

    1 year and 4 month of data collection

Secondary Outcomes (2)

  • Establish the factors associated with response of the patients who develop pleural effusion

    1 year and 4 month of data collection

  • Main characteristics of the patients who develop pleural effusion

    1 year and 4 month of data collection

Study Arms (1)

Chronic myeloid leukemia patients treated with Dasatinib

patients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days

Drug: Dasatinib

Interventions

DasatinibDRUG
Chronic myeloid leukemia patients treated with Dasatinib

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Public centers in the Mexican Republic

You may qualify if:

  • Men and women ≥15 years of age
  • Diagnosis of chronic myeloid leukemia in any phase that used dasatinib at any time between January 2008 and November 2014
  • Have received dasatinib as part of their first-line or second-line treatment for at least 45 days

You may not qualify if:

  • Patients who received dasatinib as part of any clinical trial
  • Patients who do not have complete data on the data collection sheet
  • Patients who do not have medical records available at the moment of the data verification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Leukemia

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

July 22, 2015

Primary Completion

November 30, 2016

Study Completion

March 29, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07