Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06042660

Enrollment

527

Registered

2023-09-18

Start date

2016-02-29

Completion date

2016-08-31

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

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.

Interventions

OTHERthe prevalence of comorbid conditions

analysis of history of comorbidities at the time of CML diagnosis

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
the prevalence of comorbid conditions in newly diagnosed CML patients	February - July 2016	data collected through an on-line questionnaire, descriptive data
the number of concomitant medications in newly diagnosed CML patients	February - July 2016	data collected through an on-line questionnaire, descriptive data

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026