Chronic Myeloid LeukemiaNCT06042660
Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis
An observational study of Chronic Myeloid Leukemia, run by Polish Adult Leukemia Group.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- the prevalence of comorbid conditions
- How many people
- 527 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diagnosis of chronic phase CML diagnosed between January 1st and December 31st 2014, treated with TKI (imatinib, dasatinib, nilotynib)
Who may be able to join
- 1) age ≥ 18 years; 2) diagnosis of chronic phase CML between January 1st 2005 and December 31st 2014.
Who cannot join
- primary diagnosis of CML in accelerated or blastic phase
About this study
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
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.
Read the 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
- Being tested
- the prevalence of comorbid conditions
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the prevalence of comorbid conditionsOther
analysis of history of comorbidities at the time of CML diagnosis
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed CML patients | Not described Receives: Other: the prevalence of comorbid conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of comorbid conditions in newly diagnosed CML patients
data collected through an on-line questionnaire, descriptive data
Measured: February - July 2016
the number of concomitant medications in newly diagnosed CML patients
data collected through an on-line questionnaire, descriptive data
Measured: February - July 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startFeb 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Adult Leukemia Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Krec, Polish Adult Leukemia Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042660
- Sponsor's protocol ID
- PALG CML Comorbidity
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29778693
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06042660
- Acronym / sponsor ID
- PALG CML Comorbidity
- Conditions
- Chronic Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Polish Adult Leukemia GroupUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed CML patients | – | Other: the prevalence of comorbid conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosis of chronic phase CML diagnosed between January 1st and December 31st 2014, treated with TKI (imatinib, dasatinib, nilotynib)
Key inclusion criteria (1 listed)
- 1) age ≥ 18 years; 2) diagnosis of chronic phase CML between January 1st 2005 and December 31st 2014.
Key exclusion criteria (1 listed)
- primary diagnosis of CML in accelerated or blastic phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the prevalence of comorbid conditionsanalysis of history of comorbidities at the time of CML diagnosis | Other | newly diagnosed CML patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Results publication: PubMed 29778693Gora-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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Polish Adult Leukemia Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of comorbid conditions in newly diagnosed CML patients (time frame: February - July 2016). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.