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

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.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Drug: Dasatinib

• Study Type: Observational
• Enrollment (Actual): 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Public centers in the Mexican Republic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2015
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): March 29, 2017

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Pleural Diseases; Myeloproliferative Disorders; Leukemia, Myeloid; Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Pleural Effusion; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: CA180-556

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No