Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

Sponsor

Polish Adult Leukemia Group (Other)

Overall Status

Completed

CT.gov ID

NCT06042660

Collaborator

(none)

527

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Other: the prevalence of comorbid conditions

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

Actual Enrollment :

527 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
newly diagnosed CML patients	Other: the prevalence of comorbid conditions analysis of history of comorbidities at the time of CML diagnosis

Arm

Intervention/Treatment

newly diagnosed CML patients

Other: the prevalence of comorbid conditions

analysis of history of comorbidities at the time of CML diagnosis

Outcome Measures

Primary Outcome Measures

the prevalence of comorbid conditions in newly diagnosed CML patients [February - July 2016]
data collected through an on-line questionnaire, descriptive data
the number of concomitant medications in newly diagnosed CML patients [February - July 2016]
data collected through an on-line questionnaire, descriptive data

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Polish Adult Leukemia Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Anna Krec, Project Manager of Polish Adult Leukemia Group, Polish Adult Leukemia Group

ClinicalTrials.gov Identifier:

NCT06042660

Other Study ID Numbers:

PALG CML Comorbidity

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 18, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Sep 18, 2023