Acalabrutinib Real World Italian obSErvational Study -ARISE

NCT06205498 | Active Not Recruiting

• 1 other identifier: D8221R00002
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 41

Brief 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

Keywords

Chronic Lymphocytic Leukemia; acalabrutinib; CLL; Observational

Outcome Measures

Primary Outcomes (1)

• time to acalabrutinib discontinuation

  The primary outcome is the time to acalabrutinib discontinuation (defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment) Kaplan-Meier median time to acalabrutinib discontinuation (defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment). (Note: Any acalabrutinib treatment suspension \>28 days is defined as discontinuation. Any acalabrutinib treatment suspension ≤ 28 days is defined as interruption and should not be considered for the analysis of the primary objective.

  through study completion, an average of 5 years

Secondary Outcomes (17)

• demographic and clinical characteristics of CLL patients treated with acalabrutinib

  baseline

• describe acalabrutinib treatment patterns

  through study completion, an average of 5 years

• CLL clinical stage

  baseline

• FISH profile

  baseline

• Date of birth

  baseline

Other Outcomes (3)

• measure effectiveness of acalabrutinib

  through study completion, an average of 5 years

• evaluate effectiveness of CLL treatments following acalabrutinib discontinuation

  through study completion, an average of 5 years

• estimate Healthcare Resources Utilization

  through study completion, an average of 5 years

Interventions

acalabrutinib DRUG

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

Also known as: Calquence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Investigators participating in this observational study should include all patients with CLL who initiated treatment with acalabrutinib over the period between May 1st, 2021 and April 30th, 2022, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

You may qualify if:

• 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).

You may not qualify if:

• Patients who meet any of the following criteria will be excluded:
• \. Acalabrutinib treatment initiation before 1st May 2021 or after 30th April 2022.

Sponsors & Collaborators

• AstraZeneca: lead
• Yghea: collaborator

Study Sites (41)

Research Site

Alessandria, 15121, Italy

Location

Research Site

Ancona, 60126, Italy

Location

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Bari, 70124, Italy

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Barletta, 76121, Italy

Location

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Brindisi, 72100, Italy

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Campobasso, 86100, Italy

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Catania, 95100, Italy

Location

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Catanzaro, 88100, Italy

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Cosenza, 87100, Italy

Location

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Crema, 26013, Italy

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Cuneo, 12100, Italy

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Foggia, 71122, Italy

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Frosinone, 03100, Italy

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Genova, 16132, Italy

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Lecce, 73100, Italy

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Messina, 98158, Italy

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Milan, 20122, Italy

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Milan, 20132, Italy

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Monza, 20900, Italy

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Naples, 80131, Italy

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Padova, 35128, Italy

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Pagani, 84016, Italy

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Perugia, 06132, Italy

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Pescara, 65124, Italy

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Ravenna, 48121, Italy

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Reggio Calabria, 89133, Italy

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Roma, 00133, Italy

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Roma, 00161, Italy

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Roma, 00168, Italy

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Roma, 00184, Italy

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Roma, 00189, Italy

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Rozzano, 20089, Italy

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Salerno, 84078, Italy

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San Giovanni Rotondo, 71013, Italy

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Torino, 10043, Italy

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Torino, 10073, Italy

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Torino, 10126, Italy

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Torino, 10154, Italy

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Tricase, 73039, Italy

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Varese, 21100, Italy

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Viterbo, 01100, Italy

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

acalabrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carola Boccomini

  AOU Città della Salute e della Scienza di Torino - Presidio Molinette

  PRINCIPAL INVESTIGATOR

• Chiara Borrella

  IRCCS San Gerardo Monza

  PRINCIPAL INVESTIGATOR

• Catello Califano

  PO A. TORTORA

  PRINCIPAL INVESTIGATOR

• Daniele Caracciolo

  AOU Mater Domini / Università Magna Grecia

  PRINCIPAL INVESTIGATOR

• Gioacchino Catania

  AO SS Antonio e Biagio e Cesare Arrigo

  PRINCIPAL INVESTIGATOR

• Marta Coscia

  AOU Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

• Luigi Curreli

  PO San Martino

  PRINCIPAL INVESTIGATOR

• Giovanni D'Arena

  PO S.Luca - DEA I livello

  PRINCIPAL INVESTIGATOR

• Federica De Marco

  Ospedale San Giovanni Bosco, ASL Città di Torino

  PRINCIPAL INVESTIGATOR

• Gaetano De Santis

  Ospedale "Mon. Dimiccoli" Barletta

  PRINCIPAL INVESTIGATOR

• Nicola Di Renzo

  PO Vito Fazzi ASL di Lecce

  PRINCIPAL INVESTIGATOR

• Ambra Di Veroli

  ASL Viterbo

  PRINCIPAL INVESTIGATOR

• Amalia Stefania Figuera

  AOU Policlinico G.Rodolico - San Marco

  PRINCIPAL INVESTIGATOR

• Myriam Foglietta

  AO S. Croce e Carle

  PRINCIPAL INVESTIGATOR

• Vincenzo Fraticelli

  Responsible Research Hospital

  PRINCIPAL INVESTIGATOR

• Susanna Gallo

  ASLTO4 Sedi di Ciriè - Chivasso ed Ivrea

  PRINCIPAL INVESTIGATOR

• Massimo Gentile

  AO Cosenza

  PRINCIPAL INVESTIGATOR

• Giulio Giordano

  Ospedale di riferimento regionale "A. Cardarelli" - Campobasso

  PRINCIPAL INVESTIGATOR

• Adalberto Ibatici

  Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

• Luca Laurenti

  Policlinico Universitario Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Massimo Magagnoli

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

• Luigi Malandruccolo

  Ospedale Spaziani - ASL Frosinone

  PRINCIPAL INVESTIGATOR

• Alessandro Noto

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

• Francesca Romana Mauro

  Università Sapienza di Roma

  PRINCIPAL INVESTIGATOR

• Carla Minoia

  IRCCS Giovanni Paolo II

  PRINCIPAL INVESTIGATOR

• Roberta Murru

  Ospedale Oncologico" A. Businco" - ARNAS "G. Brotzu"

  PRINCIPAL INVESTIGATOR

• Marina Motta

  Asst Degli Spedali Civili Di Brescia

  PRINCIPAL INVESTIGATOR

• Pellegrino Musto

  AOU Policlinico Consorziale di Bari

  PRINCIPAL INVESTIGATOR

• Marco De Gobbi

  AOU San Luigi Gonzaga

  PRINCIPAL INVESTIGATOR

• Getano Palumbo

  Ospedali Riuniti di Foggia

  PRINCIPAL INVESTIGATOR

• Fabrizio Pane

  Federico II University

  PRINCIPAL INVESTIGATOR

• Maria Cristina Pasquini

  Ospedale Maggiore Crema

  PRINCIPAL INVESTIGATOR

• Domenico Pastore

  PO "A.Perrino" di Brindisi

  PRINCIPAL INVESTIGATOR

• Elsa Pennese

  ASL Pescara

  PRINCIPAL INVESTIGATOR

• Rosario Potito Scalzulli

  IRCCS Casa Sollievo della Sofferenza

  PRINCIPAL INVESTIGATOR

• Lydia Scarfò

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

• Ilaria Scortechini

  AOU delle Marche

  PRINCIPAL INVESTIGATOR

• Paolo Sportoletti

  Università degli Studi di Perugia - Azienda Ospedaliera S.M. Perugia

  PRINCIPAL INVESTIGATOR

• Caterina Cecilia Stelitano

  Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

  PRINCIPAL INVESTIGATOR

• Agostino Tafuri

  AOU Sant'Andrea

  PRINCIPAL INVESTIGATOR

• Anna Tamburini

  Azienda Ospedaliera S. Giovanni Addolorata

  PRINCIPAL INVESTIGATOR

• Monica Tani

  Ospedale Santa Maria delle Croci - Ravenna

  PRINCIPAL INVESTIGATOR

• Vincenzo Pavone

  Azienda Ospedaliera Cardinale G. Panico

  PRINCIPAL INVESTIGATOR

• Andrea Visentin

  Azienda Ospedale Università Padova

  PRINCIPAL INVESTIGATOR

• Massimiliano Postorino

  Ospedale Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

• Laura Nocilli

  Ospedale Papardo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: January 16, 2024
• Study Start: August 8, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

IT (41)