Frequency and Severity of Pleural Effusion Associated With the Use of Dasatinib in Patients With Chronic Myeloid Leukemia. A Descriptive, Mexican Multicenter Study

Completed

• Conditions: Leukemia
• Interventions: Drug: Dasatinib

• Registration Number: NCT02546791
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-22
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Primary Completion: 2016-11-30
• Study Completion: 2017-03-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic myeloid leukemia patients treated with Dasatinib	Dasatinib	patients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Main characteristics of the patients who develop pleural effusion	1 year and 4 month of data collection	Characteristics: Age, gender, comorbidity
Establish the factors associated with response of the patients who develop pleural effusion	1 year and 4 month of data collection	Factors: Hematological Response; * Standardization of counts in peripheral blood with leukocytes \<10 × 10\^9 and platelets \<450 ×10\^9; * Absence of immature elements in the smear; * Basophils \<5%; * Absence of palpable splenomegaly; Complete Molecular Response (CMR); Undetectable BCR-ABL mRNA transcripts by real time quantitative and/or nested Partial Cytogenetic Response (PCR) in two consecutive blood samples of adequate quality (sensitivity \>104) Major Molecular Response (MMR); Ratio of BCR-ABL to ABL (or other housekeeping genes) ≤0.1% on the international scale