Trial Outcomes & Findings for Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma (NCT NCT04257578)

Last Updated: 2026-06-25

Results Overview

Toxicity as defined by the following: grade \>= 3 cytokine release syndrome, grade \>= 3 neurotoxicity within 30 days of infusion of axicabtagene ciloleucel. Grading will be done in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for neurotoxicity and the Lee Criteria for cytokine release syndrome, unless otherwise specified.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 30 days post axicabtagene ciloleucel infusion

Results posted on

2026-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Overall Study STARTED	23	0
Overall Study COMPLETED	23	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

No HIV-positive patients were analyzed as no HIV-positive patients were enrolled.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 30 days post axicabtagene ciloleucel infusion

Population: No HIV-positive patients were analyzed as no HIV-positive patients were enrolled.

Outcome measures

Outcome measures
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 Participants Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Incidence of Adverse Events	9 Participants	—

SECONDARY outcome

Timeframe: 30 days after T-cell infusion, with a window of -7 to +14 days

Population: Data for this outcome was analyzed separately for molecular subtypes of Diffuse Large B-cell Lymphoma (DLBCL), which includes High-Grade B-cell Lymphoma. No HIV-positive patients were analyzed as no HIV-positive patients were enrolled.

Will be assessed per Lugano criteria.

Outcome measures

Outcome measures
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 Participants Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Complete Response Rate Following Chimeric Antigen Receptor T-cells Therapy (CART) Germinal Center DLBCL Molecular Subtype	7 Participants	—
Complete Response Rate Following Chimeric Antigen Receptor T-cells Therapy (CART) Non-Germinal Center DLBCL Molecular Subtype	4 Participants	—
Complete Response Rate Following Chimeric Antigen Receptor T-cells Therapy (CART) DLBCL Molecular Subtype Unknown	1 Participants	—
Complete Response Rate Following Chimeric Antigen Receptor T-cells Therapy (CART) Primary Mediastinal Large B-cell Lymphoma and Follicular Lymphoma	2 Participants	—

SECONDARY outcome

Timeframe: Up to 5 years post treatment

Population: No HIV-positive patients were analyzed as no HIV-positive patients were enrolled.

Outcome measures

Outcome measures
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 Participants Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Overall Survival	16 Participants	—

SECONDARY outcome

Timeframe: Up to 5 years post treatment

Population: No HIV-positive patients were analyzed as no HIV-positive patients were enrolled.

Outcome measures

Outcome measures
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 Participants Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Progression-free Survival	15 Participants	—

SECONDARY outcome

Timeframe: Prior to (within 14 days of) lymphodepleting therapy

Will assess response rate (complete response + partial response + stable response) following bridging prior to CART.

Outcome measures

Outcome measures
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 Participants Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Response Rate Germinal Center DLBCL Molecular Subtype	4 Participants	—
Response Rate Non-Germinal Center DLBCL Molecular Subtype	5 Participants	—
Response Rate DLBCL Molecular Subtype Unknown	1 Participants	—
Response Rate Primary Mediastinal Large B-cell Lymphoma and Follicular Lymphoma	0 Participants	—

Adverse Events

Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort

Serious events: 9 serious events

Other events: 23 other events

Deaths: 7 deaths

Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 participants at risk Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Cardiac disorders Bradycardia	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Immune system disorders Cytokine release syndrome	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Blood and lymphatic system disorders Febrile neutropenia	8.7% 2/23 • Number of events 2 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Investigations Neurotoxicity	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Infections and infestations Lung infection	8.7% 2/23 • Number of events 2 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Injury, poisoning and procedural complications Chemotherapy-induced toxicity	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Infections and infestations Sepsis	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Gastrointestinal disorders Diverticulitis	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
General disorders Fever	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
General disorders Prolonged hospitalization	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	4.3% 1/23 • Number of events 1 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.

Other adverse events

Other adverse events
Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 participants at risk Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV
Investigations Alanine aminotransferase increased	13.0% 3/23 • Number of events 3 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Blood and lymphatic system disorders Anemia	13.0% 3/23 • Number of events 3 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Immune system disorders Cytokine release syndrom	87.0% 20/23 • Number of events 37 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Investigations Lymphocyte count decreased	39.1% 9/23 • Number of events 26 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Nervous system disorders Neurotoxicity	65.2% 15/23 • Number of events 32 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Investigations Neutrophil count decreased	78.3% 18/23 • Number of events 59 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Investigations Platelet count decreased	21.7% 5/23 • Number of events 11 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.
Investigations White blood cell decreased	34.8% 8/23 • Number of events 25 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.	— 0/0 • Adverse events were collected from the start of acalabrutinib until 30 days after the last dose of acalabrutinib, up to 15 months. All-cause mortality was monitored from the time of study enrollment up to 5 years. Only adverse events of grade 3 or higher were reported, with the exception of cytokine release syndrome and neurotoxicity, for which all grades were reported. Serious adverse events of any grade were reported.

Additional Information

Ajay Gopal, MD

University of Washington

Phone: 2066062037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort n=23 Participants Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy. Acalabrutinib: Given PO Axicabtagene Ciloleucel: Given IV	Total n=23 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants	0 Participants n=23 Participants
Age, Categorical <=18 years	0 Participants n=23 Participants	0 Participants	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=23 Participants	0 Participants	15 Participants n=23 Participants
Age, Categorical >=65 years	8 Participants n=23 Participants	0 Participants	8 Participants n=23 Participants
Age, Continuous	57 years n=23 Participants • No HIV-positive patients were analyzed as no HIV-positive patients were enrolled.	—	57 years n=23 Participants • No HIV-positive patients were analyzed as no HIV-positive patients were enrolled.
Sex: Female, Male Female	8 Participants n=23 Participants	0 Participants	8 Participants n=23 Participants
Sex: Female, Male Male	15 Participants n=23 Participants	0 Participants	15 Participants n=23 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=23 Participants	0 Participants	2 Participants n=23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=23 Participants	0 Participants	21 Participants n=23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants	0 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants	0 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Asian	1 Participants n=23 Participants	0 Participants	1 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	0 Participants n=23 Participants	0 Participants	0 Participants n=23 Participants
Race (NIH/OMB) White	22 Participants n=23 Participants	0 Participants	22 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=23 Participants	0 Participants	0 Participants n=23 Participants
Region of Enrollment United States	23 participants n=23 Participants	—	23 participants n=23 Participants
B-cell Non-Hodgkin Lymphoma Histologies Diffuse Large B-cell Lymphoma	12 Participants n=23 Participants	0 Participants	12 Participants n=23 Participants
B-cell Non-Hodgkin Lymphoma Histologies High-Grade B-cell Lymphoma	7 Participants n=23 Participants	0 Participants	7 Participants n=23 Participants
B-cell Non-Hodgkin Lymphoma Histologies Primary Mediastinal Large B-cell Lymphoma	1 Participants n=23 Participants	0 Participants	1 Participants n=23 Participants
B-cell Non-Hodgkin Lymphoma Histologies Follicular Lymphoma	3 Participants n=23 Participants	0 Participants	3 Participants n=23 Participants
Diffuse Large B-cell Lymphoma Molecular Subtypes Germinal Center	12 Participants n=19 Participants • Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.	0 Participants Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.	12 Participants n=19 Participants • Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.
Diffuse Large B-cell Lymphoma Molecular Subtypes Non-Germinal Center	6 Participants n=19 Participants • Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.	0 Participants Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.	6 Participants n=19 Participants • Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.
Diffuse Large B-cell Lymphoma Molecular Subtypes Unknown	1 Participants n=19 Participants • Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.	0 Participants Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.	1 Participants n=19 Participants • Analysis includes patients with Diffuse Large B-cell Lymphoma and does not include patients with Follicular Lymphoma or Primary Mediastinal B-cell Lymphoma as it is not applicable for those histologies.