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

Leukemia Clinical Trial

— PASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546791
• Other study ID #: CA180-556
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: July 24, 2017
• Start date: July 22, 2015
• Est. completion date: March 29, 2017

Study information

• Verified date: July 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 29, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Pleural Effusion

Intervention

Drug:
• Dasatinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form