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OpenTrials
Completed

NCT Number: NCT06042660

Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

The aim of the retrospective study was to further characterize the prevalence of comorbid conditions as well as the use of concomitant medications in newly diagnosed CML patients in a real-world setting. Hematologists from ten Polish hematological tertiary care centers were asked to analyze medical records for all consecutive CML patients diagnosed with chronic phase CML between January 1st 2005 and December 31st 2014.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

All three TKIs used as first line treatment of CML, (imatinib, dasatinib and nilotinib), may be associated with the so called "off-target" effects causing specific adverse events (AEs).

Interestingly, some co-morbidities may predispose towards developing these specific TKIs' "offtarget" AEs.

The aim of the retrospective study was to further characterize the prevalence of comorbid conditions as well as the use of concomitant medications in newly diagnosed CML patients in a real-world setting. Hematologists from ten Polish hematological tertiary care centers were asked to analyze medical records for all consecutive CML patients diagnosed with chronic phase CML between January 1st 2005 and December 31st 2014. Data were collected through on-line case report form of the Polish Adult Leukemia Group (PALG) Registry. Baseline patients' characteristics including sex, age, body mass index (BMI), risk group according to Sokal score, as well as comorbidities and concomitant therapies, were recorded at the time of CML diagnosis. The study was conducted in accordance with the provisions of the Declaration of Helsinki.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1) age ≥ 18 years; 2) diagnosis of chronic phase CML between January 1st 2005 and December 31st 2014.

Exclusion criteria

  • primary diagnosis of CML in accelerated or blastic phase

Treatment and study plan

the prevalence of comorbid conditions

Other

analysis of history of comorbidities at the time of CML diagnosis

Primary outcomes

  1. the prevalence of comorbid conditions in newly diagnosed CML patients

    Time frame: February - July 2016

    data collected through an on-line questionnaire, descriptive data

  2. the number of concomitant medications in newly diagnosed CML patients

    Time frame: February - July 2016

    data collected through an on-line questionnaire, descriptive data

Sponsors and collaborators

Lead sponsor

Polish Adult Leukemia Group

Other

Registry information

Official study title

Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis: A Retrospective Analysis of 527 Patients From the Polish Adult Leukemia Group Registry

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2023
Registry last updated
Sep 18, 2023

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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