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Chronic Lymphocytic LeukemiaARISENCT06205498

Acalabrutinib Real World Italian obSErvational Study -ARISE

An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 41 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
acalabrutinib
How many people
151 participants
Where
41 sitesItaly
Study dates
8 Aug 2023to 30 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Italy41 sites

  • Research Site

    Alessandria, 15121

  • Research Site

    Ancona, 60126

  • Research Site

    Bari, 70124

  • Research Site

    Barletta, 76121

  • Research Site

    Brindisi, 72100

  • Research Site

    Campobasso, 86100

  • Research Site

    Catania, 95100

  • Research Site

    Catanzaro, 88100

  • Research Site

    Cosenza, 87100

  • Research Site

    Crema, 26013

  • Research Site

    Cuneo, 12100

  • Research Site

    Foggia, 71122

  • Research Site

    Frosinone, 03100

  • Research Site

    Genova, 16132

  • Research Site

    Lecce, 73100

  • Research Site

    Messina, 98158

  • Research Site

    Milan, 20122

  • Research Site

    Milan, 20132

  • Research Site

    Monza, 20900

  • Research Site

    Naples, 80131

  • Research Site

    Padova, 35128

  • Research Site

    Pagani, 84016

  • Research Site

    Perugia, 06132

  • Research Site

    Pescara, 65124

  • Research Site

    Ravenna, 48121

  • Research Site

    Reggio Calabria, 89133

  • Research Site

    Roma, 00133

  • Research Site

    Roma, 00161

  • Research Site

    Roma, 00168

  • Research Site

    Roma, 00184

  • Research Site

    Roma, 00189

  • Research Site

    Rozzano, 20089

  • Research Site

    Salerno, 84078

  • Research Site

    San Giovanni Rotondo, 71013

  • Research Site

    Torino, 10043

  • Research Site

    Torino, 10073

  • Research Site

    Torino, 10126

  • Research Site

    Torino, 10154

  • Research Site

    Tricase, 73039

  • Research Site

    Varese, 21100

  • Research Site

    Viterbo, 01100

Other trials in Italy

About this study

Official title: Acalabrutinib Real World Italian obSErvational Secondary Data Collection Study of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia.

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.

Read the detailed description

Study design:

This is an Italian non-interventional / observational, multicenter, longitudinal secondary data usage study based on a retrospective cohort of patients with CLL, who initiated treatment with acalabrutinib between 1st May 2021 and 30th April 2022 (index date), regardless of the treatment status at the time of inclusion. Each patient will be followed-up up to 5 years since the last enrolled patient index date (therefore for a maximum of 72 months). Five data extraction timepoints are planned for the investigators to proceed with secondary data extraction from patients' medical records and data entry into the electronic case report form (eCRFs).

Data Source(s):

Source documents (paper or electronic) are those in which patient data are recorded and documented for the first time as part of patients' path of care (e.g., patient's hospital records, pharmacy dispensing records).

A standardized, validated eCRF will be developed to capture data extracted from source documents at each participating site.

Study Population:

All consecutive adult 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.

Outcome(s):

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).

Secondary outcomes include: Time from diagnosis to start of acalabrutinib, immunophenotype, CLL clinical stage (Binet), FISH profile, mutations, karyotype, CLL treatments before acalabrutinib, socio-demographic characteristics at baseline, medical history, concomitant treatments, COVID-19 prophylaxis and treatments, constitutional symptoms, patient clinical status, ECG/TTE, complete blood count with differential, serum chemistry, HIV and Hepatitis serology, active haemolysis, time to acalabrutinib discontinuation, acalabrutinib treatment (dosage, relative changes, temporary interruption/permanent discontinuation).

Exploratory outcomes include: Time to progression, Time to death, CLL status (according to iwCLL), Time to Next Treatment, Time to progression on next line treatment, reasons for ending of CLL treatments following acalabrutinib discontinuation, visits and hospitalizations due to CLL or suspected ADR during acalabrutinib treatment.

Being tested
acalabrutinib
Keywords
Chronic Lymphocytic Leukemia, acalabrutinib, CLL, Observational
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acalabrutinibDrug

    Also called Calquence

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 5 years

Secondary outcomes (17)

  1. demographic and clinical characteristics of CLL patients treated with acalabrutinib

    To describe demographic and clinical characteristics of CLL patients treated with acalabrutinib, by treatment line and potential associations with acalabrutinib permanent discontinuation.

    Measured: baseline

  2. describe acalabrutinib treatment patterns

    Duration of acalabrutinib suspension= time from the date of last dose before suspension to the date of acalabrutinib restart.

    Frequency of acalabrutinib interruptions Time to interruption= time from the first dose of acalabrutinib to the date of last dose before interruption Proportion of each reason for treatment ending (adverse events, disease progression, compliance issues, patient's decision, physician's choice, death, other) In case of discontinuation for adverse event: proportion of each type of adverse event.

    Frequency of acalabrutinib dose changes Proportion of each reason for dose change Time to dose change= time from the first dose of acalabrutinib to the first dose administered at the new dosage Mean dose at last acalabrutinib use Relative dose intensity= received dose/prescribed dose (where received dose is the total dose actually received by patient during the whole observation period; prescribed dose is the dose at the acalabrutinib )initiation

    Measured: through study completion, an average of 5 years

  3. CLL clinical stage

    according to Binet staging system (stage A, B, C) according to Eichhorst et al., 2020.

    Measured: baseline

  4. FISH profile

    del(11q) del(17p); trisomy 12; del(13q); normal

    Measured: baseline

  5. Date of birth

    month/year

    Measured: baseline

  6. gender

    male or famale

    Measured: baseline

  7. Height

    cm

    Measured: baseline

  8. Weight

    Kg

    Measured: throught study completion, an average of 5 years

  9. Body Mass Index

    kg/m2

    Measured: Through study completion, an average of 5 years

  10. Medical illness burden

    CIRS-G scale

    Measured: Through study completion, an average of 5 years

  11. Red blood cell count

    x10^12/L

    Measured: Through study completion, an average of 5 years

  12. White blood cell count

    x10^9/L

    Measured: Through study completion, an average of 5 years

  13. platelets count

    x10^9/L

    Measured: Through study completion, an average of 5 years

  14. hemoglobin

    gr/dL

    Measured: Through study completion, an average of 5 years

  15. differential count of lymphocytes and neutrophils

    Measured: Through study completion, an average of 5 years

  16. creatinine clearance (mL/min), aspartate transaminase (AST; U/L), alanine transaminase (ALT; U/L), gamma-glutamyl transferase (GGT; U/L), bilirubin (mg/dL), LDH (U/L), β2-microglobulin (mg/dL), IgG, IgA, IgM levels (mg/dL)

    Measured: baseline

  17. Anti-HIV antibodies test and Hepatitis serology tests including hepatitis B surface antigen (HbsAg), hepatitis B surface antibody (HbsAb), hepatitis B core antibody (anti-HBc), and hepatitis C (HCV) antibody

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start8 Aug 2023
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06205498
Sponsor's protocol ID
D8221R00002
Acronym
ARISE
Status last verified
Apr 2026
First submitted
6 Jul 2023
Last updated
23 Apr 2026
Results posted
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 41 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to acalabrutinib discontinuation (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06205498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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