Clinical trial · Observational

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

NCT02546791CI-TRIAL-00028788PASScompletedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Dasatinib	Drug	Dasatinib	ALIAS

Design

Arms and outcomes

Arms (1)

label
Chronic myeloid leukemia patients treated with Dasatinib
description
patients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days
interventionNames
1. Drug: Dasatinib

Primary outcomes (1)

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
timeFrame
1 year and 4 month of data collection

Secondary outcomes (2)

measure
Establish the factors associated with response of the patients who develop pleural effusion
timeFrame
1 year and 4 month of data collection
description
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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 15 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.