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NCT06205498: ARISE
Acalabrutinib Real World Italian obSErvational Study -ARISE
trial testing acalabrutinib in Chronic Lymphocytic Leukemia in 151 participants. Participants enrolled and being followed up; not accepting new ones.
30 April 2027
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 151 |
| Start date | 8 August 2023 |
| Primary completion | 30 April 2027 |
| Estimated completion | 30 April 2027 |
| Sites | 41 locations across Italy |
Drugs / interventions tested
- acalabrutinib (ACALABRUTINIB) — full drug profile →
Conditions studied
- Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
Sponsor
AstraZeneca — full company profile →
Who can join
18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06205498
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT03205046 — A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies · Phase 1, PHASE2 · terminated
- NCT02180711 — Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Chronic Lymphocytic Leukemia
Currently open trials in the same condition.
- NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
- NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype · Phase 2 · recruiting
- NCT07218510 — Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Smal · Phase 2 · recruiting
- NCT07288515 — Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus · recruiting
- NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06205498 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 22 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06205498.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing