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

Study Overview
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Brief Summary
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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.

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

Conditions
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Leukemia

Intervention / Treatment
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* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic myeloid leukemia patients treated with Dasatinib<br>patients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days | Drug: Dasatinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the factors associated with response of the patients who develop pleural effusion | 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 | 1 year and 4 month of data collection | 
| Main characteristics of the patients who develop pleural effusion | Characteristics: Age, gender, comorbidity | 1 year and 4 month of data collection |