Follicular LymphomaNCT06794268
A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting
An observational study of Follicular Lymphoma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 1 site in United States.
Trial summary
The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Lisocabtagene maraleucel
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 31 Aug 2044
- 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 include adults with relapsed/refractory follicular lymphoma that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
Who may be able to join
- Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA
Who cannot join
- Participants known to be participating in investigational studies at the time of liso-cel, infusion
- Participants treated with liso-cel for the treatment of R/R FL Grade 3b
- Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
United States1 site, 1 recruiting
- Recruiting
CIBMTR
Milwaukee, Wisconsin, 53226
About this study
Official title: Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Follicular Lymphoma in the Postmarketing Setting
The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities
- Conditions
- Follicular Lymphoma
- Being tested
- Lisocabtagene maraleucel
- Keywords
- Follicular Lymphoma
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisocabtagene maraleucelBiological
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving lisocabtagene maraleucel treatment | Not described Receives: Biological: Lisocabtagene maraleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) of interest
AEs of interest include:
- Secondary malignancies
- Cytokine release syndrome (CRS) Grade ≥ 3
- Neurotoxicity Grade ≥ 3
- Prolonged cytopenias
- Pregnancy outcome
- Tumor lysis syndrome (TLS) Grade ≥ 3
- Serious infections (ie, those requiring treatment)
- Organ toxicities Grade ≥ 3
- Hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS)-like toxicities
- Aggravated graft-versus-host disease (GvHD)
Measured: Up to 15 years
Incidence of other adverse events (AEs) of interest
Other clinically important events that have not yet been identified as part of the liso-cel safety profile
Measured: Up to 15 years
Secondary outcomes (6)
Overall survival (OS)
Measured: Up to 15 years
Overall response rate (ORR)
Measured: Up to 15 years
Complete remission rate (CRR)
Measured: Up to 15 years
Duration of response (DOR)
Measured: Up to 15 years
Progression-free survival (PFS)
Measured: Up to 15 years
Time to next treatment (TTNT)
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 posted27 Jan 2025
- Study start4 Feb 2025
- Primary completion31 Aug 2044 (estimated)
- Study completion31 Aug 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyThe 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
- 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
- NCT06794268
- Sponsor's protocol ID
- CA082-1175
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2025
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. 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 Follicular Lymphoma in the Postmarketing Setting
- ClinicalTrials.gov ID
- NCT06794268
- Acronym / sponsor ID
- CA082-1175
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 31 Aug 2044 (estimated)
- Study completion
- 31 Aug 2044 (estimated)
- First posted
- 27 Jan 2025 (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.
The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving lisocabtagene maraleucel treatment | – | Biological: 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 include adults with relapsed/refractory follicular lymphoma that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
Key inclusion criteria (1 listed)
- Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA
Key exclusion criteria (3 listed)
- Participants known to be participating in investigational studies at the time of liso-cel, infusion
- Participants treated with liso-cel for the treatment of R/R FL Grade 3b
- Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product
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 product label | Biological | Participants receiving lisocabtagene maraleucel treatment |
Primary outcome
Incidence of adverse events (AEs) of interest
Time frame: Up to 15 years
AEs of interest include: * Secondary malignancies * Cytokine release syndrome (CRS) Grade ≥ 3 * Neurotoxicity Grade ≥ 3 * Prolonged cytopenias * Pregnancy outcome * Tumor lysis syndrome (TLS) Grade ≥ 3 * Serious infections (ie, those requiring treatment) * Organ toxicities Grade ≥ 3 * Hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS)-like toxicities * Aggravated graft-versus-host disease (GvHD)
Incidence of other adverse events (AEs) of interest
Time frame: Up to 15 years
Other clinically important events that have not yet been identified as part of the liso-cel safety profile
6 secondary outcomes
Overall survival (OS)
Time frame: Up to 15 years
Overall response rate (ORR)
Time frame: Up to 15 years
Complete remission rate (CRR)
Time frame: Up to 15 years
Duration of response (DOR)
Time frame: Up to 15 years
Progression-free survival (PFS)
Time frame: Up to 15 years
Time to next treatment (TTNT)
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 24 Feb 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
First line of the email MUST contain NCT # and Site #. contact
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 Follicular Lymphoma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. 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?
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) of interest (time frame: Up to 15 years). The study lists 2 primary outcomes in all. 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 24 Feb 2025.