A Phase 2 interventional study of ACALABRUTINIB and LISOCABTAGENE MARALEUCEL in Refractory Aggressive B-cell Lymphomas, Refractory B-Cell Non-Hodgkin Lymphoma and Aggressive B-cell NHL, sponsored by Patrick C. Johnson, MD. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Patrick C. Johnson, MD · Phase 2, Interventional, and Treatment
This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma.
This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce
This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleucel.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- Participants will receive one infusion of liso-cel and will receive acalabrutinib capsules twice daily as long as treatment is tolerated and disease does not worsen (disease progression) for up to one year.
Participants will be followed by clinical visits for up to 5 years and the medical record will be monitored for up to 15 years.
It is expected that about 27 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The U.S. Food and Drug Administration (FDA) has not approved acalabrutinib for this specific disease, but it has been approved for other uses.
The U.S. FDA has approved lisocabtagene maraleucel for this specific disease.
AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and supplying acalabrutinib.
1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.
This study's enrollment of 28 is below the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →Patrick C. Johnson, MD is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Serologic status reflecting active hepatitis B or C infection
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, breastfeeding should be discontinued if the mother is treated with acalabrutinib.
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
Drug: ACALABRUTINIB · Drug: LISOCABTAGENE MARALEUCEL · Drug: Lymphodepleting chemotherapy
Oral, twice daily, timing and dosage per protocol
Also known as: Calquence
via IV timings and dosage per protocol
Also known as: Breyanzi
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.
Also known as: cyclophosphamide and fludarabine
Complete Response Rate (CRR)
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.)
Time frame: 1 year 8 months
Overall Response Rate
Time frame: 3 Months
Overall Response Rate
Time frame: 6 Months
Overall Response Rate
Time frame: 12 Months
Progression Free Survival
PFS will be summarized using Kaplan-Meier estimates.
Time frame: 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
Overall Survival
OS will be summarized using Kaplan- Meier estimates.
Time frame: defined as the time from registration to death due to any cause, or censored at date last known alive up to 15 years
Duration of Response
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.
Time frame: time from first response to disease progression or death up to 15 years
Event Free Survival
Time to event outcomes will be estimated using Kaplan Meier method or cumulative incidence curves
Time frame: from registration to death from any cause, disease progression, or starting a new anti-lymphoma therapy, whichever occurs first up to 15 years
Rates of Bridging Therapy
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
Time frame: 1 years
FACT-G QOL
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
Time frame: 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
ICU Rates
ICU admission rates defined as the percentage of participants with an ICU admission within 90 days of liso-cel infusion. Reported with descriptive statistics
Time frame: up to 90 days
Re-hospitalization Rates
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
Time frame: up to 90 days
ER Visit Rates
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.
Time frame: within 90 days
Length of Stay
Length of stay (LOS) defined as the number of days a participant is hospitalized for liso-cel infusion.
Time frame: 1 year
Rates of Acalabrutinib Discontinuation Due to Toxicity
Rates of acalabrutinib discontinuation in participants due to acalabrutinib toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: time of their first treatment up to 3 years
Number of Participants Treatment Related Adverse Event NCI CTCAE 5.0
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: up to 3 Years
| Milestone | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
|---|---|
| Started | 28 |
| Completed | 26 |
| Not completed | 2 |
| Withdrew: Development of concurrent medical condition that interferes with trial participation | 1 |
| Withdrew: Physician decision | 1 |
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.)
| Participants | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
|---|---|
| Complete Response Rate (CRR) | 22 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
PFS will be summarized using Kaplan-Meier estimates.
Results for this outcome have not been posted.
OS will be summarized using Kaplan- Meier estimates.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Time to event outcomes will be estimated using Kaplan Meier method or cumulative incidence curves
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
ICU admission rates defined as the percentage of participants with an ICU admission within 90 days of liso-cel infusion. Reported with descriptive statistics
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Length of stay (LOS) defined as the number of days a participant is hospitalized for liso-cel infusion.
Results for this outcome have not been posted.
Rates of acalabrutinib discontinuation in participants due to acalabrutinib toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Results for this outcome have not been posted.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Results for this outcome have not been posted.
Collected over 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.). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACALABRUTINIB and LISOCABTAGENE MARALEUCEL | 0/27 (0%) | 7/27 (25.9%) | 27/27 (100%) |
| Event | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
|---|---|
| FeverGeneral disorders | 2/27 |
| Alanine aminotransferase increasedInvestigations | 1/27 |
| Aspartate aminotransferase increasedInvestigations | 1/27 |
| Cytokine Release SyndromeInvestigations | 1/27 |
| HypercalcemiaMetabolism and nutrition disorders | 1/27 |
| HypotensionVascular disorders | 1/27 |
| NauseaGastrointestinal disorders | 1/27 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/27 |
| Event | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
|---|---|
| FatigueGeneral disorders | 23/27 |
| NauseaGastrointestinal disorders | 18/27 |
| Neutrophil count decreasedInvestigations | 17/27 |
| Cytokine release syndromeImmune system disorders | 16/27 |
| ConstipationGastrointestinal disorders | 15/27 |
| DehydrationMetabolism and nutrition disorders | 15/27 |
| DizzinessNervous system disorders | 14/27 |
| CoughRespiratory, thoracic and mediastinal disorders | 13/27 |
| HeadacheNervous system disorders | 13/27 |
| PainGeneral disorders | 13/27 |
| Age, Continuous(years) | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
|---|---|
| Median | 70 (28 to 85) |
| Sex: Female, Male(Participants) | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
|---|---|
| Female | 15 |
| Male | 13 |
| Race (NIH/OMB)(Participants) | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 16 |
| More than one race | 1 |
| Unknown or Not Reported | 6 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
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Patrick C. Johnson, MD