Overview

This trial is active, not recruiting.

Condition small cell lung cancer
Treatment dasatinib
Target BCR-ABL
Sponsor Bristol-Myers Squibb
Start date January 2008
End date March 2017
Trial size 100 participants
Trial identifier NCT02546791, CA180-556

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
patients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days
dasatinib

Primary Outcomes

Measure
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
time frame: 1 year and 4 month of data collection

Secondary Outcomes

Measure
Establish the factors associated with response of the patients who develop pleural effusion
time frame: 1 year and 4 month of data collection
Main characteristics of the patients who develop pleural effusion
time frame: 1 year and 4 month of data collection

Eligibility Criteria

Male or female participants at least 15 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Frequency and Severity of Pleural Effusion Associated With the Use of Dasatinib in Patients With Chronic Myeloid Leukemia. A Descriptive, Mexican Multicenter Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.