Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

Overview

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.

Full Title of Study: “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

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: July 2016

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.

Interventions

• Other: the prevalence of comorbid conditions
  • analysis of history of comorbidities at the time of CML diagnosis

Arms, Groups and Cohorts

• newly diagnosed CML patients

Clinical Trial Outcome Measures

Primary Measures

• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Polish Adult Leukemia Group
• Provider of Information About this Clinical Study
  • Principal Investigator: Anna Krec, Project Manager of Polish Adult Leukemia Group – Polish Adult Leukemia Group

Citations Reporting on Results

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. Erratum In: Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):692.