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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02546791

Acronym

PASS

Enrollment

101

Registered

2015-09-11

Start date

2015-07-22

Completion date

2017-03-29

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

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.

Interventions

DRUGDasatinib

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
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
Main characteristics of the patients who develop pleural effusion	1 year and 4 month of data collection	Characteristics: Age, gender, comorbidity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026