Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

Chronic Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06042660
• Other study ID #: PALG CML Comorbidity
• Status: Completed
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2023
• Source: Polish Adult Leukemia Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Polish Adult Leukemia Group

References & Publications (1)

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. Comorbid — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prevalence of comorbid conditions in newly diagnosed CML patients	data collected through an on-line questionnaire, descriptive data	February - July 2016
Primary	the number of concomitant medications in newly diagnosed CML patients	data collected through an on-line questionnaire, descriptive data	February - July 2016

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