Trial Outcomes & Findings for Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas (NCT NCT05583149)

Last Updated: 2026-01-29

Results Overview

The CRR is defined as the percentage of subjects achieving an objective response of complete response (CR) according to the Lugano Classification (Chesson et al., 2014), prior to start of another non-study anticancer therapy. CR is defined as a complete metabolic and radiologic response (Lugano score 1-3, target nodes/nodal masses must regress to ≤ 1.5 cm in longest diameter.)

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

1 year 8 months

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	ACALABRUTINIB and LISOCABTAGENE MARALEUCEL The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ACALABRUTINIB and LISOCABTAGENE MARALEUCEL The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib
Overall Study Development of concurrent medical condition that interferes with trial participation	1
Overall Study Physician Decision	1

Baseline Characteristics

Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACALABRUTINIB and LISOCABTAGENE MARALEUCEL n=28 Participants The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib ACALABRUTINIB: Oral, twice daily, timing and dosage per protocol LISOCABTAGENE MARALEUCEL: via IV timings and dosage per protocol Lymphodepleting chemotherapy: lymphodepleting chemotherapy with cyclophosphamide and fludarabine once a day for 3 days via IV about 2-4 hours. This will occur only once prior to lisocabtagene maraleucel infusion.
Age, Continuous	70 years n=41 Participants
Sex: Female, Male Female	15 Participants n=41 Participants
Sex: Female, Male Male	13 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	3 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	2 Participants n=41 Participants
Race (NIH/OMB) White	16 Participants n=41 Participants
Race (NIH/OMB) More than one race	1 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=41 Participants

PRIMARY outcome

Timeframe: 1 year 8 months

Outcome measures

Outcome measures
Measure	ACALABRUTINIB and LISOCABTAGENE MARALEUCEL n=27 Participants The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib
Complete Response Rate (CRR)	22 Participants

SECONDARY outcome

Timeframe: 3 Months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation up to 15 years

PFS will be summarized using Kaplan-Meier estimates.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: defined as the time from registration to death due to any cause, or censored at date last known alive up to 15 years

OS will be summarized using Kaplan- Meier estimates.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: time from first response to disease progression or death up to 15 years

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).DOR will be summarized using Kaplan-Meier estimates.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from registration to death from any cause, disease progression, or starting a new anti-lymphoma therapy, whichever occurs first up to 15 years

Time to event outcomes will be estimated using Kaplan Meier method or cumulative incidence curves

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 years

Rates of bridging therapy defined as the percentage of participants requiring any lymphoma-directed therapy other than the investigational therapy in order to control the disease prior to liso-cel infusion. Reported with descriptive statistics

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, day -5 (+/- 3 days), day +7 (+/- 3 days), day +30 (+/- 7 days), day +90 (+/- 14 days), and day +180 (+/- 14 days) after liso-cel infusion

Functional Assessment of Cancer Treatment-General (FACT-G). The FACT-G consists of four subscales assessing well-being across four domains. These self-reported measures possess strong psychometric properties and have been validated for patients with cancer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 90 days

ICU admission rates defined as the percentage of participants with an ICU admission within 90 days of liso-cel infusion. Reported with descriptive statistics

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 90 days

All cause re-hospitalization rates defined as the percentage of participants who experience an unplanned hospitalization within 90 days of liso-cel infusion. Planned hospital admissions for a procedure or treatment will be excluded. Reported with descriptive statistics

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 90 days

All cause ER visit rates defined as the percentage of participants who experience an unplanned ER visit within 90 days of liso-cel infusion. Planned ER visits/hospital admissions for a procedure or treatment will be excluded.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Length of stay (LOS) defined as the number of days a participant is hospitalized for liso-cel infusion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: time of their first treatment up to 3 years

Rates of acalabrutinib discontinuation in participants due to acalabrutinib toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 Years

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Outcome measures

Outcome data not reported

Adverse Events

ACALABRUTINIB and LISOCABTAGENE MARALEUCEL

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ACALABRUTINIB and LISOCABTAGENE MARALEUCEL n=27 participants at risk The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib
Investigations Alanine aminotransferase increased	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Aspartate aminotransferase increased	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Cytokine Release Syndrome	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Fever	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hypercalcemia	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Vascular disorders Hypotension	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Nausea	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)

Other adverse events

Other adverse events
Measure	ACALABRUTINIB and LISOCABTAGENE MARALEUCEL n=27 participants at risk The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib
Infections and infestations Abdominal infection	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Abdominal Pain	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Psychiatric disorders Agitation	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Alanine aminotransferase increased	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Alkaline phosphatase increased	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Immune system disorders Allergic reaction	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Alopecia	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Blood and lymphatic system disorders Anemia	22.2% 6/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Anorexia	33.3% 9/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Psychiatric disorders Anxiety	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Arthritis	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Aspartate aminotransferase increased	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Cardiac disorders Atrial fibrillation	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Cardiac disorders Atrial flutter	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Back pain	33.3% 9/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Bacteremia	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Bloating	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Blood antidiuretic hormone abnormal	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Blood bilirubin increased	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Eye disorders Blurred vision	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Bone pain	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Bronchial infection	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Bronchial stricture	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Injury, poisoning and procedural complications Bruising	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Eye disorders Cataract	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Chills	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Renal and urinary disorders Chronic kidney disease	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Cognitive disturbance	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Colitis	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Constipation	55.6% 15/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Cough	48.1% 13/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Creatinine increased	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Immune system disorders Cytokine release syndrome	59.3% 16/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Dehydration	55.6% 15/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Psychiatric disorders Depression	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Diarrhea	44.4% 12/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Dizziness	51.9% 14/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Eye disorders Dry eye	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Dry mouth	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Dry skin	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Dysarthria	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Dysgeusia	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Dyspepsia	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Dysphagia	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Dyspnea	25.9% 7/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Renal and urinary disorders Dysuria	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Edema face	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Edema limbs	25.9% 7/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Epistaxis	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Eye disorders Eye disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Injury, poisoning and procedural complications Fall	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Fatigue	85.2% 23/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Blood and lymphatic system disorders Febrile neutropenia	29.6% 8/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Fecal incontinence	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Fever	37.0% 10/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Fibrinogen decreased	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Flank pain	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Flu like symptoms	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Gastric ulcer	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 9/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders General disorders and administration site conditions - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Glucose intolerance	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Headache	48.1% 13/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Ear and labyrinth disorders Hearing impaired	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Cardiac disorders Heart failure	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Vascular disorders Hematoma	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Hemorrhoids	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hypercalcemia	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hyperglycemia	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Dysphasia	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Hyperhidrosis	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hyperlipidemia	25.9% 7/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Vascular disorders Hypertension	40.7% 11/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hypoglycemia	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hypokalemia	29.6% 8/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hypomagnesemia	25.9% 7/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hyponatremia	25.9% 7/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Hypophosphatemia	29.6% 8/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Vascular disorders Hypotension	44.4% 12/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Hypothermia	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Endocrine disorders Hypothyroidism	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Immune system disorders Immune system disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Infections and infestations - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Injury, poisoning and procedural complications Infusion related reaction	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations INR increased	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Psychiatric disorders Insomnia	25.9% 7/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Intracranial hemorrhage	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Investigations - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Lethargy	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Lung infection	22.2% 6/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Mucositis oral	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Muscle cramp	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Myalgia	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Nasal congestion	29.6% 8/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Nausea	66.7% 18/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Neck edema	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Neck pain	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Nervous system disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Neutrophil count decreased	63.0% 17/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Non-cardiac chest pain	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Osteoporosis	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
General disorders Pain	48.1% 13/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Musculoskeletal and connective tissue disorders Pain in extremity	37.0% 10/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Pain of skin	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Pancreatitis	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Papulopustular rash	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Paresthesia	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Reproductive system and breast disorders Perineal pain	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Peripheral sensory neuropathy	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Platelet count decreased	18.5% 5/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Productive cough	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Reproductive system and breast disorders Prostatic obstruction	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Pruritus	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Psychiatric disorders Psychiatric disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Purpura	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Rash maculo-papular	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Rectal pain	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Renal and urinary disorders Renal and urinary disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Seizure	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Sepsis	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Cardiac disorders Sinus bradycardia	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Sinusitis	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Cardiac disorders Sinus tachycardia	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Skin infection	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Skin and subcutaneous tissue disorders Skin ulceration	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Sleep apnea	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Sneezing	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Somnolence	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Respiratory, thoracic and mediastinal disorders Sore throat	22.2% 6/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Syncope	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Endocrine disorders Testosterone deficiency	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Vascular disorders Thromboembolic event	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Thrush	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Ear and labyrinth disorders Tinnitus	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Toothache	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Nervous system disorders Tremor	22.2% 6/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Metabolism and nutrition disorders Tumor lysis syndrome	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Upper respiratory infection	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Renal and urinary disorders Urinary frequency	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Renal and urinary disorders Urinary incontinence	22.2% 6/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Renal and urinary disorders Urinary retention	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Infections and infestations Urinary tract infection	14.8% 4/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Renal and urinary disorders Urinary urgency	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Reproductive system and breast disorders Vaginal discharge	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Reproductive system and breast disorders Vaginal dryness	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Injury, poisoning and procedural complications Vascular access complication	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Cardiac disorders Ventricular tachycardia	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Ear and labyrinth disorders Vertigo	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Gastrointestinal disorders Vomiting	22.2% 6/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Weight gain	11.1% 3/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations White blood cell decreased	7.4% 2/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)
Investigations Weight loss	3.7% 1/27 • All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.)

Additional Information

Patrick Connor Johnson, MD

Massachusetts General Hospital

Phone: 6177244000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place