Acalabrutinib Real World Italian obSErvational Study -ARISE

Summary

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

DRUG

acalabrutinib

patients with CLL who initiated treatment with acalabrutinib over the period between 1st May 2021 and 30th April 2022, according to Italian legislation dlg 219/2006 art.125

Sponsors & Collaborators

• Yghea

  collaborator UNKNOWN

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Carola Boccomini · AOU Città della Salute e della Scienza di Torino - Presidio Molinette

• Chiara Borrella · IRCCS San Gerardo Monza

• Catello Califano · PO A. TORTORA

• Daniele Caracciolo · AOU Mater Domini / Università Magna Grecia

• Gioacchino Catania · AO SS Antonio e Biagio e Cesare Arrigo

• Marta Coscia · AOU Città della Salute e della Scienza

• Luigi Curreli · PO San Martino

• Giovanni D'Arena · PO S.Luca - DEA I livello

• Federica De Marco · Ospedale San Giovanni Bosco, ASL Città di Torino

• Gaetano De Santis · Ospedale "Mon. Dimiccoli" Barletta

• Nicola Di Renzo · PO Vito Fazzi ASL di Lecce

• Ambra Di Veroli · ASL Viterbo

• Amalia Stefania Figuera · AOU Policlinico G.Rodolico - San Marco

• Myriam Foglietta · AO S. Croce e Carle

• Vincenzo Fraticelli · Responsible Research Hospital

• Susanna Gallo · ASLTO4 Sedi di Ciriè - Chivasso ed Ivrea

• Massimo Gentile · AO Cosenza

• Giulio Giordano · Ospedale di riferimento regionale "A. Cardarelli" - Campobasso

• Adalberto Ibatici · Ospedale Policlinico San Martino

• Luca Laurenti · Policlinico Universitario Gemelli IRCCS

• Massimo Magagnoli · Istituto Clinico Humanitas

• Luigi Malandruccolo · Ospedale Spaziani - ASL Frosinone

• Alessandro Noto · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

• Francesca Romana Mauro · Università Sapienza di Roma

• Carla Minoia · IRCCS Giovanni Paolo II

• Roberta Murru · Ospedale Oncologico" A. Businco" - ARNAS "G. Brotzu"

• Marina Motta · Asst Degli Spedali Civili Di Brescia

• Pellegrino Musto · AOU Policlinico Consorziale di Bari

• Marco De Gobbi · AOU San Luigi Gonzaga

• Getano Palumbo · Ospedali Riuniti di Foggia

• Fabrizio Pane · Federico II University

• Maria Cristina Pasquini · Ospedale Maggiore Crema

• Domenico Pastore · PO "A.Perrino" di Brindisi

• Elsa Pennese · ASL Pescara

• Rosario Potito Scalzulli · IRCCS Casa Sollievo della Sofferenza

• Lydia Scarfò · IRCCS Ospedale San Raffaele

• Ilaria Scortechini · AOU delle Marche

• Paolo Sportoletti · Università degli Studi di Perugia - Azienda Ospedaliera S.M. Perugia

• Caterina Cecilia Stelitano · Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

• Agostino Tafuri · AOU Sant'Andrea

• Anna Tamburini · Azienda Ospedaliera S. Giovanni Addolorata

• Monica Tani · Ospedale Santa Maria delle Croci - Ravenna

• Vincenzo Pavone · Azienda Ospedaliera Cardinale G. Panico

• Andrea Visentin · Azienda Ospedale Università Padova

• Massimiliano Postorino · Ospedale Policlinico Tor Vergata

• Laura Nocilli · Ospedale Papardo

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-08

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• Italy

Study Locations