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