Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

Completed

• Conditions: Chronic Myeloid Leukemia
• Interventions: Other: the prevalence of comorbid conditions

• Registration Number: NCT06042660
• Lead Sponsor: Polish Adult Leukemia Group

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 Timeline

• Study Start: 2016-02
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2023-09
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-16
• Last Update Submitted: 2023-09-16
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
newly diagnosed CML patients	the prevalence of comorbid conditions	-

Primary Outcome Measures

Name	Time	Method
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