Clinical trial NCT06042660: Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis
Official title: Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis: A Retrospective Analysis of 527 Patients From the Polish Adult Leukemia Group Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Polish Adult Leukemia Group
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with diagnosis of chronic phase CML diagnosed between January 1st and December 31st 2014, treated with TKI (imatinib, dasatinib, nilotynib)

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.

Eligibility criteria: 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

Primary outcomes:
measure: the prevalence of comorbid conditions in newly diagnosed CML patients
timeFrame: February - July 2016
measure: the number of concomitant medications in newly diagnosed CML patients
timeFrame: February - July 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gora-Tybor J, Sacha T, Waclaw J, Niesiobedzka-Krezel J, Grzybowska-Izydorczyk O, Medras E, Deren-Wagemann I, Patkowska E, Seferynska I, Lewandowski K, Wache A, Blajer-Olszewska B, Watek M, Kotwica-Mojzych K, Wasilewska E, Warzocha K, Jamroziak K. Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis: A Retrospective Analysis of 527 Patients From the Polish Adult Leukemia Group Registry. Clin Lymphoma Myeloma Leuk. 2018 Jul;18(7):e283-e285. doi: 10.1016/j.clml.2018.05.001. Epub 2018 May 9. No abstract available.