Chronic Lymphocytic LeukemiaPICAROSNCT05999877

PICAROS - Acalabrutinib RWE on 1L CLL in Spain

An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 50 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Lymphocytic Leukemia
How many people: 315 participants
Where: 50 sitesSpain
Study dates: 11 Jul 2023to 31 Mar 2029
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: The study aims to include approximately 315 patients in the cohort 1 and 103 patients in the cohort 2 who started acalabrutinib for the first time for the treatment of their CLL. To minimize selection biases, all patients (alive or deceased) identified on acalabrutinib will be eligible for inclusion into the study. These patients will be included from approximately 50 hospitals distributed throughout Spain.

Who may be able to join

Age ≥18 years old at starting acalabrutinib treatment.
Diagnosis of CLL.
Start of acalabrutinib treatment (index date) as per the CLL SmPC:
in treatment-naïve CLL patients or those switching in first-line between first-generation BTK inhibitor to acalabrutinib due to intolerance in absence of progression according to routine clinical practice within the year before the first site initiation visit (cohort 1).
in treatment-naïve CLL patients for the fixed-duration treatment combination of acalabrutinib plus venetoclax (with or without obinutuzumab) according to routine clinical practice from the EMA approval (i.e., 2 June 2025) (cohort 2).
Decision to administer acalabrutinib must be made and documented prior to inclusion into the study and must follow local clinical practice.
Informed consent (for alive patients).

Who cannot join

Enrolled in any clinical trial during acalabrutinib treatment.
Patients who are unable to understand the study and its questionnaires due to insufficient knowledge of the Spanish language or their health status.

Trial locations and contacts

50 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

City, postcode or hospital

Sites recruiting now only

50 sites in 1 country

Spain50 sites, 15 recruiting

Research Site
Alicante, Valencia, 3010
Recruiting
Research Site
Almería, Andalusia, 4009
Recruiting
Research Site
Barcelona, Catalonia, 8003
Active, not recruiting
Research Site
Barcelona, Catalonia, 8025
Active, not recruiting
Research Site
Barcelona, Catalonia, 8035
Active, not recruiting
Research Site
Barcelona, Catalonia, 8036
Active, not recruiting
Research Site
Córdoba, Andalusia, 14004
Recruiting
Research Site
Donostia / San Sebastian, Basque Country, 20014
Withdrawn
Research Site
El Palmar, Murcia, 30120
Active, not recruiting
Research Site
Galdakao, Basque Country, 48960
Withdrawn
Research Site
Granada, Andalusia, 18014
Recruiting
Research Site
Granollers, Catalonia, 8402
Active, not recruiting
Research Site
Guadalajara, Castille-La Mancha, 19002
Recruiting
Research Site
Jaén, Andalusia, 23007
Active, not recruiting
Research Site
L'Hospitalet de Llobregat, Catalonia, 8908
Active, not recruiting
Research Site
Las Palmas de Gran Canaria, Canary Islands, 35016
Active, not recruiting
Research Site
Las Palmas de Gran Canaria, Canary Islands, 35019
Active, not recruiting
Research Site
Lleida, Catalonia, 25198
Active, not recruiting
Research Site
Madrid, Madrid, 28006
Recruiting
Research Site
Madrid, Madrid, 28031
Active, not recruiting
Research Site
Madrid, Madrid, 28034
Active, not recruiting
Research Site
Madrid, Madrid, 28040
Recruiting
Research Site
Madrid, Madrid, 28041
Recruiting
Research Site
Madrid, Madrid, 28046
Recruiting
Research Site
Madrid, Madrid, 28905
Active, not recruiting
Research Site
Madrid, Madrid, 28911
Active, not recruiting
Research Site
Majadahonda, Madrid, 28222
Active, not recruiting
Research Site
Málaga, Andalusia, 29010
Active, not recruiting
Research Site
Marbella, Andalusia, 29603
Active, not recruiting
Research Site
Murcia, Murcia, 30008
Recruiting
Research Site
Ourense, Galicia, 32005
Recruiting
Research Site
Oviedo, Principality of Asturias, 33011
Active, not recruiting
Research Site
Palma de Mallorca, Balearic Islands, 7010
Active, not recruiting
Research Site
Palma de Mallorca, Balearic Islands, 7198
Active, not recruiting
Research Site
Salamanca, Castille and León, 37007
Active, not recruiting
Research Site
San Cristóbal de La Laguna, Canary Islands, 38320
Recruiting
Research Site
Santander, Cantabria, 39008
Active, not recruiting
Research Site
Santiago de Compostela, Galicia, 15706
Active, not recruiting
Research Site
Segovia, Castille and León, 40002
Active, not recruiting
Research Site
Seville, Andalusia, 41013
Recruiting
Research Site
Terrassa, Catalonia, 8221
Active, not recruiting
Research Site
Toledo, Castille-La Mancha, 45004
Active, not recruiting
Research Site
Valencia, Valencia, 46010
Active, not recruiting
Research Site
Valencia, Valencia, 46014
Active, not recruiting
Research Site
Valencia, Valencia, 46026
Active, not recruiting
Research Site
Valladolid, Castille and León, 47003
Active, not recruiting
Research Site
Valladolid, Castille and León, 47012
Active, not recruiting
Research Site
Vigo, Galicia, 36312
Recruiting
Research Site
Zaragoza, Aragon, 50009
Active, not recruiting
Research Site
Zaragoza, Aragon, 50009
Recruiting

Other trials in Spain

About this study

Official title: Non-interventional Cohort Study of Patients Previously Untreated or First-generation BTKi Intolerant With Chronic Lymphocytic Leukemia Describing the First-line Use of Acalabrutinib and Its Real-world Outcomes in Spain: the PICAROS Study

This is a multicenter non-interventional study (NIS) of patients with CLL treated with first-line acalabrutinib according to routine clinical practice in Spain. It included an initial cohort of patients who initiated treat-to-progression acalabrutinib for the first time within the year before the first site initiation visit, both for previously untreated CLL and after switching in first line from another BTK inhibitor due to intolerance in absence of progression (cohort 1). This cohort is complemented with the addition of another regarding the first-line fixed-duration acalabrutinib use with venetoclax in routine practice (cohort 2).

Read the detailed description

This is a multicenter, non-interventional study (NIS) based on ambispective (including retrospective and/or prospective) real-world data collection of patients with CLL who received treatment with acalabrutinib for the first time in Spain.

It included an initial cohort of patients who initiated treat-to-progression acalabrutinib for the first time within the year before the first site initiation visit, both for previously untreated CLL and after switching in first line from another BTK inhibitor due to intolerance in absence of progression (cohort 1). This cohort is complemented with the addition of another regarding the first-line fixed-duration acalabrutinib use with venetoclax in routine practice (cohort 2).

For the cohort 1, the start of acalabrutinib treatment (index date) was prior to the first site initiation visit. For both cohorts 1 and 2, the clinical decision of starting patient on acalabrutinib has to independently occur prior to the patient inclusion into this study. Patients' eligibility for study inclusion is regardless of their current status of acalabrutinib therapy, for example, patients already deceased or discontinued therapy are still eligible to be included into this study. Patient data will be collected both retrospectively and/or prospectively up to approximately 32 months from the first site initiation visit for cohort 1, and approximately 25 months after the inclusion of the last patient in the cohort 2. For patients who received acalabrutinib therapy and have deceased, only retrospective medical chart review will be conducted.

Conditions: Chronic Lymphocytic Leukemia
Keywords: Observational, Chronic lymphocytic leukemia, Acalabrutinib
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.

Study groups in NCT05999877
Study group	Role	What they receive
Cohort 1		Patients who initiated treat-to-progression acalabrutinib for the first time within the year before the first site initiation visit as per routine clinical practice, both for previously untreated CLL and after switching in first line from another BTK inhibitor due to intolerance in absence of progression.
Cohort 2		Patients with first-line fixed-duration acalabrutinib use with venetoclax in routine clinical practice.

What is being measured

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

Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1).
Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1).
In addition to this outcome measured in the overall cohort, it will also be assessed by the following factors:
1. the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression),
2. presence/absence of risk factors (i.e., del17p, TP53 mutation, and unmutated IGHV).
3. cardiovascular comorbidities (yes/no).
Measured: 24 months after treatment initiation (cohort 1).
Real-world overall response rate (rwORR) achieved until the end of the observational period for first-line fixed duration acalabrutinib therapy (cohort 2)
rwORR (i.e., the proportion of patients that achieved complete or partial response) achieved until the end of the observational period for first-line fixed-duration acalabrutinib therapy as assessed by the treating physician (cohort 2). Complete response may include complete response, complete response with incomplete marrow recovery, or unconfirmed complete response (marrow biopsy not performed). Partial response may include partial response, or partial response with lymphocytosis. The rwORR will be assessed by the treating physician in routine clinical practice, including the use or not of the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. The end of observational period for first-line fixed-duration combinations of acalabrutinib is defined as the start date of a subsequent line therapy or study end date, whichever comes first.
Measured: From fixed-duration acalabrutinib start to the start date of a subsequent line therapy or study end date (cohort 2), assessed up to 25 months after the inclusion of the last patient in the cohort 2.

Secondary outcomes (7)

Acalabrutinib±venetoclax doses (cohorts 1 and 2).
Acalabrutinib±venetoclax doses (e.g., starting does and dose adjustments), overall (cohorts 1 and 2) and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
In cohort 2, doses (e.g., starting dose, dose adjustments, maximum dose achieved) and reasons for changes within the acalabrutinib±venetoclax fixed-duration regimen will also be described globally and for each drug separately, as well as the time to reach the maximal dose.
Measured: At start date and subsequent dose adjustments during acalabrutinib±venetoclax administration assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Patients with acalabrutinib±venetoclax dose adjustments (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %) (cohorts 1 and 2).
Acalabrutinib±venetoclax dose adjustments, temporary interruptions, and permanent discontinuations, overall (cohorts 1 and 2) and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
In patients with regimen modifications within cohort 2, the proportion of patients with these regimen modifications and the time from treatment initiation to the regimen modification within same line therapy prior to progression (e.g., treatment duration and number of cycles prior to the modification, and reason for the modification). In cohort 2, temporary interruptions, permanent discontinuations, and their reasons for changes within the acalabrutinib±venetoclax fixed-duration regimen will also be described globally and for each drug separately, as well as the proportion of patients requiring dose reductions after achieving maximum dose.
Measured: From acalabrutinib±venetoclax start to acalabrutinib±venetoclax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Treatment duration in months (cohorts 1 and 2).
Treatment duration (cohorts 1 and 2), overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
In cohort 2, also median number of completed cycles and the proportion of patients who complete 14 cycles.
Baseline patient characteristics associated with treatment duration in multivariate analyses, overall (cohorts 1 and 2) and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
Measured: From acalabrutinib±venetoclax start to acalabrutinib±venetoclax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib (cohort 1).
Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1).
The PDC will be based on data available on acalabrutinib treatment in pharmacy records, and defined as the percentage of days a patient has the medication available in a given period of time:
PDC (%)=(No.days covered)/(No.days of interest)×100
Measured: From acalabrutinib start to acalabrutinib end, assessed up to 32 months of prospective study follow-up (cohort 1).
TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause) (cohorts 1 and 2).
TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause [i.e. deaths are not censored]), overall (cohorts 1 and 2) and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
Measured: From the date of first dose of acalabrutinib to first dose of next CLL treatment or death, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause) (cohorts 1 and 2).
OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause), overall (cohorts 1 and 2) and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
Measured: From the date of first dose of acalabrutinib to death, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Adverse events that lead to acalabrutinib±venetoclax dose changes, temporary interruptions, or permanent discontinuation; that are considered serious during acalabrutinib±venetoclax treatment; and events of clinical interest (cohorts 1 and 2).
Adverse events that lead to acalabrutinib±venetoclax dose changes, temporary interruptions, or permanent discontinuation.
Adverse events that are considered serious (including fatal events) during acalabrutinib±venetoclax treatment, globally and treatment related (when available).
Events of clinical interest (atrial fibrillation, hypertension, bleeding, infections, ventricular arrhythmias, hepatotoxicity, secondary primary malignancies, cytopenia, and pneumonitis) during acalabrutinib treatment, globally and treatment related (when available).
They will be described overall (cohorts 1 and 2) and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
Measured: From acalabrutinib±venetoclax start to acalabrutinib±venetoxlax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.

Timeline

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

11 Jul 202331 Mar 2029

First posted21 Aug 2023
Study start11 Jul 2023
Primary completion31 Mar 2029 (estimated)
Study completion31 Mar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Cohort
Time perspective: Other
Enrolment: 315 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05999877
Sponsor's protocol ID: D8221R00003
Acronym: PICAROS
Status last verified: Nov 2026
First submitted: 29 Jun 2023
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
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RecruitingObservational study
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Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic

All Chronic Lymphocytic Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Cohort Study of Patients Previously Untreated or First-generation BTKi Intolerant With Chronic Lymphocytic Leukemia Describing the First-line Use of Acalabrutinib and Its Real-world Outcomes in Spain: the PICAROS Study
ClinicalTrials.gov ID: NCT05999877
Acronym / sponsor ID: PICAROS / D8221R00003
Conditions: Chronic Lymphocytic Leukemia
Keywords: Observational, Chronic lymphocytic leukemia, Acalabrutinib
Study type: Observational
Recruitment status: Recruiting
Enrolment: 315 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 11 Jul 2023 (actual)
Primary completion: 31 Mar 2029 (estimated)
Study completion: 31 Mar 2029 (estimated)
First posted: 21 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Cohort 1	–	–Patients who initiated treat-to-progression acalabrutinib for the first time within the year before the first site initiation visit as per routine clinical practice, both for previously untreated CLL and after switching in first line from another BTK inhibitor due to intolerance in absence of progression.
Cohort 2	–	–Patients with first-line fixed-duration acalabrutinib use with venetoclax in routine clinical practice.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study aims to include approximately 315 patients in the cohort 1 and 103 patients in the cohort 2 who started acalabrutinib for the first time for the treatment of their CLL. To minimize selection biases, all patients (alive or deceased) identified on acalabrutinib will be eligible for inclusion into the study. These patients will be included from approximately 50 hospitals distributed throughout Spain.

Key inclusion criteria (7 listed)

Age ≥18 years old at starting acalabrutinib treatment.
Diagnosis of CLL.
Start of acalabrutinib treatment (index date) as per the CLL SmPC:
in treatment-naïve CLL patients or those switching in first-line between first-generation BTK inhibitor to acalabrutinib due to intolerance in absence of progression according to routine clinical practice within the year before the first site initiation visit (cohort 1).
in treatment-naïve CLL patients for the fixed-duration treatment combination of acalabrutinib plus venetoclax (with or without obinutuzumab) according to routine clinical practice from the EMA approval (i.e., 2 June 2025) (cohort 2).

Key exclusion criteria (2 listed)

Enrolled in any clinical trial during acalabrutinib treatment.
Patients who are unable to understand the study and its questionnaires due to insufficient knowledge of the Spanish language or their health status.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1).
Time frame: 24 months after treatment initiation (cohort 1).
Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1). In addition to this outcome measured in the overall cohort, it will also be assessed by the following factors: 1. the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression), 2. presence/absence of risk factors (i.e., del17p, TP53 mutation, and unmutated IGHV). 3. cardiovascular comorbidities (yes/no).
Real-world overall response rate (rwORR) achieved until the end of the observational period for first-line fixed duration acalabrutinib therapy (cohort 2)
Time frame: From fixed-duration acalabrutinib start to the start date of a subsequent line therapy or study end date (cohort 2), assessed up to 25 months after the inclusion of the last patient in the cohort 2.
rwORR (i.e., the proportion of patients that achieved complete or partial response) achieved until the end of the observational period for first-line fixed-duration acalabrutinib therapy as assessed by the treating physician (cohort 2). Complete response may include complete response, complete response with incomplete marrow recovery, or unconfirmed complete response (marrow biopsy not performed). Partial response may include partial response, or partial response with lymphocytosis. The rwORR will be assessed by the treating physician in routine clinical practice, including the use or not of the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. The end of observational period for first-line fixed-duration combinations of acalabrutinib is defined as the start date of a subsequent line therapy or study end date, whichever comes first.

7 secondary outcomes

Acalabrutinib±venetoclax doses (cohorts 1 and 2).
Time frame: At start date and subsequent dose adjustments during acalabrutinib±venetoclax administration assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Patients with acalabrutinib±venetoclax dose adjustments (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %) (cohorts 1 and 2).
Time frame: From acalabrutinib±venetoclax start to acalabrutinib±venetoclax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Treatment duration in months (cohorts 1 and 2).
Time frame: From acalabrutinib±venetoclax start to acalabrutinib±venetoclax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib (cohort 1).
Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 32 months of prospective study follow-up (cohort 1).
TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause) (cohorts 1 and 2).
Time frame: From the date of first dose of acalabrutinib to first dose of next CLL treatment or death, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause) (cohorts 1 and 2).
Time frame: From the date of first dose of acalabrutinib to death, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Adverse events that lead to acalabrutinib±venetoclax dose changes, temporary interruptions, or permanent discontinuation; that are considered serious during acalabrutinib±venetoclax treatment; and events of clinical interest (cohorts 1 and 2).
Time frame: From acalabrutinib±venetoclax start to acalabrutinib±venetoxlax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Individual participant dataSharing planned: 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. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

50 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 50 sites in Spain.

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 7 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Spain. 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?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1). (time frame: 24 months after treatment initiation (cohort 1).). The study lists 2 primary outcomes in all. 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 NCT05999877.

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 4 Nov 2026.