REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania (NCT06170671) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania
Romania250 participantsStarted 2023-12-13
Plain-language summary
Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (age \>18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma
* Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol
* Patients able and willing to provide their written informed consent to participate in the study
Exclusion Criteria:
* The treatment with acalabrutinib was initiated during an interventional clinical trial
* Enrolment performed less than 30 days from start of treatment with acalabrutinib
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a real-world observational study in Romania tracking how long patients stay on acalabrutinib before stopping it, could you explain whether joining would affect my actual treatment plan or if I would just be monitored on whatever regimen you already recommend?
2The study is no longer enrolling new participants — does that mean there's no opportunity for me to take part, and if so, are there other active studies on acalabrutinib for CLL that I might be eligible for?
3Because this is a real-world outcomes study rather than a randomized clinical trial, what does that mean for what we can learn from its results about how well acalabrutinib works and how safe it is for patients like me?
4The main thing being tracked is how long patients stay on acalabrutinib before discontinuing — what are the most common reasons patients in your experience stop this drug, and how might those reasons apply to my specific situation?
5Given that this trial is observational and based in Romania, would the findings from this study be relevant to my care here, and is acalabrutinib already considered a standard treatment option for my stage of CLL?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to acalabrutinib treatment discontinuation (TTD)
Timeframe: Once a year during the 3 years of follow up since acalabrutinib start