Marginal Zone LymphomaNCT07777120
Liso-Cel in Relapsed/Refractory Marginal Zone Lymphoma
An observational study of Marginal Zone Lymphoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This non-interventional study will use information already reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) registry during routine clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- lisocabtagene maraleucel
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 31 Mar 2048
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult participants with relapsed or refractory marginal zone lymphoma (R/R MZL) who have received at least 2 prior lines of systemic therapy, who are treated with at least 1 infusion of lisocabtagene maraleucel in the postmarketing setting, who are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
Who may be able to join
- Participants who meet the following eligibility criteria will be selected from the registry:
- Participants of 18 years of age or older at the time of infusion
- Participants with a diagnosis of relapsed or refractory marginal zone lymphoma (R/R MZL)
- Participants have received at least two prior lines of systemic therapy
- Participants have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel:
- used for the treatment of R/R MZL,
Show all 9Show fewer
- within the FDA-approved indication and dosage per the United States prescribing information and
- product specifications approved for commercial release in the USA.
- Participants have consented to share their data with the registry and the Sponsor.
Who cannot join
- Participants who meet the following exclusion criterion will not be eligible for selection from the registry:
- Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for International Blood and Marrow Transplant Research (CIBMTR)
Milwaukee, Wisconsin, 53226
About this study
Official title: Non-interventional Cohort Study of Patients Treated With Liso-Cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Marginal Zone Lymphoma in the Postmarketing Setting
This non-interventional study will use information already reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) registry during routine clinical care. The study will assess the long-term safety and effectiveness of lisocabtagene maraleucel in participants with relapsed/refractory marginal zone lymphoma.
- Conditions
- Marginal Zone Lymphoma
- Being tested
- lisocabtagene maraleucel
- Keywords
- lisocabtagene maraleucel, liso-cel, Breyanzi, relapsed/refractory marginal zone lymphoma, R/R MZL, chimeric antigen receptor T cell therapy, CAR T cell therapy, CIBMTR registry
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lisocabtagene maraleucelBiological
As per United States prescribing information
| Study group | Role | What they receive |
|---|---|---|
| Lisocabtagene maraleucel | Adult participants with relapsed or refractory marginal zone lymphoma (R/R MZL) treated with lisocabtagene maraleucel Receives: Biological: lisocabtagene maraleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of selected adverse events after lisocabtagene maraleucel infusion
Selected adverse events include:
- secondary malignancies
- cytokine release syndrome (CRS) Grade ≥ 3
- neurotoxicity Grade ≥ 3
- prolonged cytopenias
- pregnancy outcome
- treatment-emergent adverse events including: hypogammaglobulinemia, tumor lysis syndrome Grade ≥ 3, serious infections requiring treatment, organ toxicities Grade ≥ 3, hemophagocytic lymphohistiocytosis/macrophage activation syndrome-like toxicities, aggravated graft-versus-host disease, and other toxicities occurring after lisocabtagene maraleucel infusion.
Measured: Up to 15 years
Secondary outcomes (4)
Overall survival from first lisocabtagene maraleucel infusion
Overall survival is the time from the date of first lisocabtagene maraleucel infusion to the date of death due to any cause.
Measured: Up to 15 years
Overall response rate after lisocabtagene maraleucel infusion
Overall response rate is the proportion of participants with a best overall response of complete response or partial response, recorded from the time of lisocabtagene maraleucel infusion until disease relapse or progression, end of study, or the start of new anti-cancer therapy including hematopoietic stem cell transplantation.
Measured: Up to 15 years
Complete response rate after lisocabtagene maraleucel infusion
Complete response rate is the proportion of participants with a best overall response of complete response from the time of lisocabtagene maraleucel infusion until disease relapse or progression, end of study, or the start of another anti-cancer therapy including hematopoietic stem cell transplantation.
Measured: Up to 15 years
Progression-free survival from first lisocabtagene maraleucel infusion
Progression-free survival is the time from the date of first lisocabtagene maraleucel infusion to the date of event, defined as the first documented relapse or progression or death due to any cause, whichever happens first.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start24 Mar 2026
- Primary completion31 Mar 2048 (estimated)
- Study completion31 Mar 2048 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777120
- Sponsor's protocol ID
- CA082-1205
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Cohort Study of Patients Treated With Liso-Cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Marginal Zone Lymphoma in the Postmarketing Setting
- ClinicalTrials.gov ID
- NCT07777120
- Acronym / sponsor ID
- CA082-1205
- Conditions
- Marginal Zone Lymphoma
- Keywords
- lisocabtagene maraleucel, liso-cel, Breyanzi, relapsed/refractory marginal zone lymphoma, R/R MZL, chimeric antigen receptor T cell therapy, CAR T cell therapy, CIBMTR registry
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 31 Mar 2048 (estimated)
- Study completion
- 31 Mar 2048 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional study will use information already reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) registry during routine clinical care. The study will assess the long-term safety and effectiveness of lisocabtagene maraleucel in participants with relapsed/refractory marginal zone lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lisocabtagene maraleucel | – | Biological: lisocabtagene maraleucelAdult participants with relapsed or refractory marginal zone lymphoma (R/R MZL) treated with lisocabtagene maraleucel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult participants with relapsed or refractory marginal zone lymphoma (R/R MZL) who have received at least 2 prior lines of systemic therapy, who are treated with at least 1 infusion of lisocabtagene maraleucel in the postmarketing setting, who are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
Key inclusion criteria (9 listed)
- Participants who meet the following eligibility criteria will be selected from the registry:
- Participants of 18 years of age or older at the time of infusion
- Participants with a diagnosis of relapsed or refractory marginal zone lymphoma (R/R MZL)
- Participants have received at least two prior lines of systemic therapy
- Participants have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel:
Key exclusion criteria (2 listed)
- Participants who meet the following exclusion criterion will not be eligible for selection from the registry:
- Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion.
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 |
|---|---|---|
| lisocabtagene maraleucelAs per United States prescribing information | Biological | Lisocabtagene maraleucel |
Primary outcome
Incidence and severity of selected adverse events after lisocabtagene maraleucel infusion
Time frame: Up to 15 years
Selected adverse events include: * secondary malignancies * cytokine release syndrome (CRS) Grade ≥ 3 * neurotoxicity Grade ≥ 3 * prolonged cytopenias * pregnancy outcome * treatment-emergent adverse events including: hypogammaglobulinemia, tumor lysis syndrome Grade ≥ 3, serious infections requiring treatment, organ toxicities Grade ≥ 3, hemophagocytic lymphohistiocytosis/macrophage activation syndrome-like toxicities, aggravated graft-versus-host disease, and other toxicities occurring after lisocabtagene maraleucel infusion.
4 secondary outcomes
Overall survival from first lisocabtagene maraleucel infusion
Time frame: Up to 15 years
Overall response rate after lisocabtagene maraleucel infusion
Time frame: Up to 15 years
Complete response rate after lisocabtagene maraleucel infusion
Time frame: Up to 15 years
Progression-free survival from first lisocabtagene maraleucel infusion
Time frame: Up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Marginal Zone Lymphoma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
RecruitingPhase 2
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma
Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma, Gastric Mucosa-Associated Lymphoid Tissue Lymphoma
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
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.
Bristol Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marginal Zone Lymphoma, run by Bristol-Myers Squibb at 1 site 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 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Incidence and severity of selected adverse events after lisocabtagene maraleucel infusion (time frame: Up to 15 years). 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 20 Aug 2026.