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Acalabrutinib Real World Italian obSErvational Study -ARISE
Acalabrutinib Real World Italian obSErvational Study -ARISE

NCT06205498

Active Not RecruitingN/A

Sponsor: AstraZeneca

Conditions: Chronic Lymphocytic Leukemia

Interventions: acalabrutinib

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria All consecutive patients with CLL who received acalabrutinib according to Italian legislation dlg 219/2006 art.125 will be eligible for inclusion in the study, subject to site agreement and patient consent to participate.

Patients must meet the following criteria for study entry:

1. Age ≥ 18 years old at the date of consent subscription.
2. Diagnosis of CLL.
3. Treatment of CLL with acalabrutinib at physician's discretion initiated between 1st May 2021 and 30th April 2022.
4. Informed consent to participate in the study and privacy form signed by the patient (or their legal representative).

Exclusion Criteria

Patients who meet any of the following criteria will be excluded:

1\. Acalabrutinib treatment initiation before 1st May 2021 or after 30th April 2022.
Locations (41)
  • Alessandria, Italy
  • Ancona, Italy
  • Bari, Italy
  • Barletta, Italy
  • Brindisi, Italy
  • Campobasso, Italy
  • Catania, Italy
  • Catanzaro, Italy
  • Cosenza, Italy
  • Crema, Italy
  • Cuneo, Italy
  • Foggia, Italy
  • Frosinone, Italy
  • Genova, Italy
  • Lecce, Italy
  • Messina, Italy
  • Milan, Italy
  • Milan, Italy
  • Monza, Italy
  • Naples, Italy
  • Padova, Italy
  • Pagani, Italy
  • Perugia, Italy
  • Pescara, Italy
  • Ravenna, Italy
  • Reggio Calabria, Italy
  • Roma, Italy
  • Roma, Italy
  • Roma, Italy
  • Roma, Italy
  • + 11 more on CT.gov