Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Other: the prevalence of comorbid conditions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| newly diagnosed CML patients<br> | Other: the prevalence of comorbid conditions<br>* analysis of history of comorbidities at the time of CML diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

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