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Completed

NCT Number: NCT02546791

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

Primary outcomes

  1. 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

    Time frame: 1 year and 4 month of data collection

Secondary outcomes

  1. Establish the factors associated with response of the patients who develop pleural effusion

    Time frame: 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

  2. Main characteristics of the patients who develop pleural effusion

    Time frame: 1 year and 4 month of data collection

    Characteristics: Age, gender, comorbidity

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Acronym: PASS

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 11, 2015
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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