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Clinical Trials/NCT06042660
NCT06042660CompletedNot Applicable

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

Polish Adult Leukemia Group0 sites527 target enrollmentStarted: February 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
527
Primary Endpoint
the prevalence of comorbid conditions in newly diagnosed CML patients

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

the prevalence of comorbid conditions in newly diagnosed CML patients

Time Frame: February - July 2016

data collected through an on-line questionnaire, descriptive data

the number of concomitant medications in newly diagnosed CML patients

Time Frame: February - July 2016

data collected through an on-line questionnaire, descriptive data

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Polish Adult Leukemia Group
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Krec

Project Manager of Polish Adult Leukemia Group

Polish Adult Leukemia Group

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