NCT06042660

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
• Phase: —
• Study type: Observational
• Enrollment: 527 (actual)
• Sponsor: Polish Adult Leukemia Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	the prevalence of comorbid conditions	analysis of history of comorbidities at the time of CML diagnosis

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2023-09-18
• Last updated: 2023-09-18