NCT06205498Active, not recruiting
Acalabrutinib Real World Italian obSErvational Study -ARISE
Acalabrutinib Real World Italian obSErvational Secondary Data Collection Study of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia.
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the adults in the Western world, with an annual incidence of approximately 5 cases per 100,000 inhabitants in Italy. Acalabrutinib (CalquenceTM), a selective second-generation Bruton Tyrosine Kinase (BTK) inhibitor developed by AstraZeneca, has been assessed for the treatment of CLL in three phase III clinical trials, ELEVATE-TN (treatment-naïve CLL), ASCEND and ELEVATE R/R (relapsed and refractory CLL). These pivotal randomized clinical trials established the efficacy and safety of acalabrutinib in patients with CLL and based on these data CalquenceTM received EMA approval in November 2020 for the treatment of CLL in adult patients and received AIFA (Agenzia Italiana del Farmaco) reimbursement as monotherapy in December 2021. However, further data are still required to evaluate the use of acalabrutinib in the real-life conditions of post-marketing authorization. The primary aim of ARISE study is to evaluate the time to treatment discontinuation and reasons for discontinuation for acalabrutinib in a real world setting of patients with CLL. This study will provide the first real-world data on the use of acalabrutinib in the treatment of CLL in Italy.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 151 (actual)
- First submitted
- 6 Jul 2023
- Start date
- 8 Aug 2023
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT06205498
What you commit to
- Study type: Observational
- Participants enrolled: 151
- From 8 Aug 2023 to the primary completion date, 30 Apr 2027
- 33 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients who meet any of the following criteria will be excluded:
- 1\. Acalabrutinib treatment initiation before 1st May 2021 or after 30th April 2022.
Who the study is looking for
- Patients must meet the following criteria for study entry:
- Age ≥ 18 years old at the date of consent subscription.
- Diagnosis of CLL.
- Treatment of CLL with acalabrutinib at physician's discretion initiated between 1st May 2021 and 30th April 2022.
- Informed consent to participate in the study and privacy form signed by the patient (or their legal representative).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.