Refractory Aggressive B-cell LymphomasPhase 2NCT05583149
Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas
A Phase 2 study testing ACALABRUTINIB, LISOCABTAGENE MARALEUCEL and Lymphodepleting chemotherapy in people with Refractory Aggressive B-cell Lymphomas and Refractory B-Cell Non-Hodgkin Lymphoma, run by Patrick C. Johnson, MD at 2 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Aggressive B-cell Lymphomas, Refractory B-Cell Non-Hodgkin Lymphoma, Aggressive B-cell NHL
- What is being tested?
- ACALABRUTINIB, LISOCABTAGENE MARALEUCEL and Lymphodepleting chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2023to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥18 years with histologically confirmed aggressive B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, and including DLBCL NOS, T cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr virus [EBV] positive DLBCL NOS, primary mediastinal [thymic] large B-cell lymphoma (PMBCL), high grade B-cell lymphoma NOS, or high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements [double/triple hit lymphoma (DHL/THL)]; and grade 3B follicular lymphoma. Patients with primary CNS lymphoma are not eligible. Patients with secondary CNS involvement by lymphoma are eligible if they otherwise meet all eligibility criteria.
- Relapsed or refractory to at least 2 prior lines of systemic lymphoma therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylating agent.
- PET-positive measurable disease
- ECOG Performance status 0-2
- Estimated creatinine clearance of ≥30 mL/min, calculated using the Cockcroft and Gault equation (if male, [140Age] x Mass [kg] / [72 x creatinine g/dL];multiply by 0.85 if female)
- Alanine Aminotransferase (ALT) <= 2.5 times the ULN
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- Bilirubin <= 2 x ULN (or <= 3.0 mg/dL for patients with Gilbert-Meulengracht syndrome or lymphomatous involvement of the liver)
- Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) >= 40% confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)
- For subjects with atrial fibrillation, atrial fibrillation must be controlled and asymptomatic
- Absolute neutrophil count (ANC) >= 1000/mm3
- Platelets >= 50,000/mm3
- Adequate pulmonary function, defined as <= CTCAE Grade 1 dyspnea and SaO2 > 91% on room air
- Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
- Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib.
- Willing and able to participate in all required evaluations and procedures in this study protocol.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
Who cannot join
- Another active malignancy which requires concurrent cancer-directed therapy
- Previous treatment with gene therapy product or adoptive T cell therapy
- Allogeneic stem cell transplant within 90 days of leukapheresis
- Active acute or chronic GVHD
- HIV infection
- Serologic status reflecting active hepatitis B or C infection
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- Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before enrollment and must be willing to undergo DNA PCR testing during the study. Those who are HbsAg-positive or hepatitis B PCR positive will be excluded.
- Subjects who are hepatitis C antibody positive will need to have a negative PCR result before enrollment. Those who are hepatitis C PCR positive will be excluded.
- Uncontrolled infection
- Clinically relevant CNS pathology
- History of cardiovascular conditions within the past 6 months, including class III or IV heart failure as defined by New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or clinically significant arrhythmias: Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
- Autoimmune disease requiring chronic systemic corticosteroids at a dose of greater than 10 mg of prednisone daily or an equivalent dose of another corticosteroid
- Treatment with alemtuzumab within 6 months leukapheresis or fludarabine or cladribine within 3 months of leukapheresis
- Therapeutic anticoagulation
- Bleeding diathesis
- Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication.
- Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components.
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.
- Prothrombin time (PT)/INR or aPTT (in the absence of lupus anticoagulant) >2x ULN.
- Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- Major surgical procedure within 28 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- Breastfeeding or pregnant: Pregnant women are excluded from this study because acalabrutinib is an agent with the potential for teratogenic or abortifacient effects.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Phase 2 Study of Acalabrutinib in Combination With Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas
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
Read the detailed description
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.
- Conditions
- Refractory Aggressive B-cell Lymphomas, Refractory B-Cell Non-Hodgkin Lymphoma, Aggressive B-cell NHL, Diffuse Large B-cell Lymphoma (DLBCL), De Novo or Transformed Indolent B-cell Lymphoma, DLBCL, Nos Genetic Subtypes
- Being tested
- ACALABRUTINIB, LISOCABTAGENE MARALEUCEL, Lymphodepleting chemotherapy
- Keywords
- Refractory aggressive B-cell lymphomas, Refractory B-Cell Non-Hodgkin Lymphoma, Aggressive B-cell NHL, Diffuse Large B-cell Lymphoma (DLBCL), De novo or transformed indolent B-cell lymphoma, DLBCL, nos Genetic Subtypes, T cell/histiocyte-rich large B-cell lymphoma, EBV-Positive DLBCL, nos, Primary mediastinal [thymic] large B-cell lymphoma (PMBCL), High-Grade B-Cell Lymphoma, nos, C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma, Grade 3b Follicular Lymphoma, C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACALABRUTINIBDrug
Also called Calquence
Oral, twice daily, timing and dosage per protocol
LISOCABTAGENE MARALEUCELDrug
Also called Breyanzi
via IV timings and dosage per protocol
Lymphodepleting chemotherapyDrug
Also called cyclophosphamide and fludarabine
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.
| Study group | Role | What they receive |
|---|---|---|
| ACALABRUTINIB and LISOCABTAGENE MARALEUCEL | Experimental | 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 Receives: Drug: ACALABRUTINIB; Drug: LISOCABTAGENE MARALEUCEL; Drug: Lymphodepleting chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 1 year 8 months
Secondary outcomes (15)
Overall Response Rate
Measured: 3 Months
Overall Response Rate
Measured: 6 Months
Overall Response Rate
Measured: 12 Months
Progression Free Survival
PFS will be summarized using Kaplan-Meier estimates.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: within 90 days
Length of Stay
Length of stay (LOS) defined as the number of days a participant is hospitalized for liso-cel infusion.
Measured: 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
Measured: 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
Measured: up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Mar 2023
- Primary completion23 Nov 2024
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory Aggressive B-cell LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick C. Johnson, MD
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Patrick C. Johnson, MD, Massachusetts General Hospital
- Investigators
- Connor Johnson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583149
- Sponsor's protocol ID
- 21-422
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2022
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Acalabrutinib in Combination With Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas
- ClinicalTrials.gov ID
- NCT05583149
- Acronym / sponsor ID
- 21-422
- Conditions
- Refractory Aggressive B-cell Lymphomas, Refractory B-Cell Non-Hodgkin Lymphoma, Aggressive B-cell NHL, Diffuse Large B-cell Lymphoma (DLBCL), De Novo or Transformed Indolent B-cell Lymphoma, DLBCL, Nos Genetic Subtypes
- Keywords
- Refractory aggressive B-cell lymphomas, Refractory B-Cell Non-Hodgkin Lymphoma, Aggressive B-cell NHL, Diffuse Large B-cell Lymphoma (DLBCL), De novo or transformed indolent B-cell lymphoma, DLBCL, nos Genetic Subtypes, T cell/histiocyte-rich large B-cell lymphoma, EBV-Positive DLBCL, nos
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Patrick C. Johnson, MDUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACALABRUTINIB and LISOCABTAGENE MARALEUCEL | Experimental | Drug: ACALABRUTINIB, Drug: LISOCABTAGENE MARALEUCEL, Drug: Lymphodepleting chemotherapyThe research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult patients ≥18 years with histologically confirmed aggressive B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, and including DLBCL NOS, T cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr virus [EBV] positive DLBCL NOS, primary mediastinal [thymic] large B-cell lymphoma (PMBCL), high grade B-cell lymphoma NOS, or high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements [double/triple hit lymphoma (DHL/THL)]; and grade 3B follicular lymphoma. Patients with primary CNS lymphoma are not eligible. Patients with secondary CNS involvement by lymphoma are eligible if they otherwise meet all eligibility criteria.
- Relapsed or refractory to at least 2 prior lines of systemic lymphoma therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylating agent.
- PET-positive measurable disease
- ECOG Performance status 0-2
- Estimated creatinine clearance of ≥30 mL/min, calculated using the Cockcroft and Gault equation (if male, [140Age] x Mass [kg] / [72 x creatinine g/dL];multiply by 0.85 if female)
Key exclusion criteria (25 listed)
- Another active malignancy which requires concurrent cancer-directed therapy
- Previous treatment with gene therapy product or adoptive T cell therapy
- Allogeneic stem cell transplant within 90 days of leukapheresis
- Active acute or chronic GVHD
- HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACALABRUTINIBAlso: CalquenceOral, twice daily, timing and dosage per protocol | Drug | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
| LISOCABTAGENE MARALEUCELAlso: Breyanzivia IV timings and dosage per protocol | Drug | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
| Lymphodepleting chemotherapyAlso: cyclophosphamide and fludarabinelymphodepleting 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. | Drug | ACALABRUTINIB and LISOCABTAGENE MARALEUCEL |
Primary outcome
Complete Response Rate (CRR)
Time frame: 1 year 8 months
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.)
15 secondary outcomes
Overall Response Rate
Time frame: 3 Months
Overall Response Rate
Time frame: 6 Months
Overall Response Rate
Time frame: 12 Months
Progression Free Survival
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
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
Time frame: time from first response to disease progression or death up to 15 years
Event Free Survival
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
Time frame: 1 years
FACT-G QOL
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
Time frame: up to 90 days
Re-hospitalization Rates
Time frame: up to 90 days
ER Visit Rates
Time frame: within 90 days
Length of Stay
Time frame: 1 year
Rates of Acalabrutinib Discontinuation Due to Toxicity
Time frame: time of their first treatment up to 3 years
Number of Participants Treatment Related Adverse Event NCI CTCAE 5.0
Time frame: up to 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connor Johnson, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACALABRUTINIB, LISOCABTAGENE MARALEUCEL and Lymphodepleting chemotherapy in people with Refractory Aggressive B-cell Lymphomas and Refractory B-Cell Non-Hodgkin Lymphoma, run by Patrick C. Johnson, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CRR) (time frame: 1 year 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.