Relapsed or Refractory Follicular LymphomaPhase 3NCT06313996
A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma
A Phase 3 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with Relapsed or Refractory Follicular Lymphoma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Follicular Lymphoma
- What is being tested?
- Cyclophosphamide, Doxorubicin and Vincristine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Mar 2024to 16 Oct 2031
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Participants must have measurable disease.
- Participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants that have histologically confirmed Follicular Lymphoma (FL) (Grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening.
- Participants that have Relapsed or refractory FL, as assessed by the Investigator.
- Participants that have received at least one prior line and no more than three prior lines of systemic therapy including a combination of an anti-CD20 antibody and an alkylating agent.
- Participants that received one prior line of systemic therapy are eligible if they present with high risk features.
Who cannot join
- Participants must not have any history of heart problems.
- Participants must not have any bleeding disorders.
- Participants must not have any Central Nervous System involvement by Follicular Lymphoma or other brain conditions.
- Other protocol-defined Inclusion/Exclusion criteria apply.
About this study
Official title: A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)
The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.
Read the detailed description
The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint.
The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria.
Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization.
Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.
- Being tested
- Cyclophosphamide, Doxorubicin, Vincristine, Rituximab, Prednisone
- Keywords
- Lisocabtagene Maraleucel, Liso-cel, Follicular Lymphoma
- Medical subject headings
- Recurrence, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Specified dose on specified days
DoxorubicinDrug
Specified dose on specified days
VincristineDrug
Specified dose on specified days
RituximabDrug
Specified dose on specified days
PrednisoneDrug
Specified dose on specified days
BendamustineDrug
Specified dose on specified days
LenalidomideDrug
Specified dose on specified days
FludarabineDrug
Specified dose on specified days
Liso-celDrug
Also called Lisocabtagene Maraleucel, BREYANZI
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide) Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Rituximab; Drug: Prednisone; Drug: Bendamustine; Drug: Lenalidomide |
| Arm B | Experimental | Lisocabtagene Maraleucel Receives: Drug: Fludarabine; Drug: Liso-cel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Defined as the time from randomization to death due to any cause or progressive disease (PD) per independent review committee (IRC) assessment using the Lugano 2014 Criteria, whichever occurs first
Measured: Up to 5 years from the last participant randomized
Secondary outcomes (19)
Complete response (CR)
Defined as participants achieving a complete response per IRC assessment using the Lugano 2014 Criteria
Measured: Up to 5 years from the last participant randomized
Overall survival (OS)
Defined as the time from randomization to death due to any cause
Measured: Up to approximately 7 years
Overall response (OR)
Defined as participants achieving a response (CR or partial response (PR)) per IRC assessment using the Lugano 2014 Criteria
Measured: Up to 5 years from the last participant randomized
Duration of response (DOR)
Defined as the time from first response (CR or PR) per IRC assessment using the Lugano 2014 Criteria to PD or death due to any cause, whichever occurs first
Measured: Up to 5 years from the last participant randomized
Event-free survival (EFS)
Defined as the time from randomization to the first documentation of progressive disease (PD) per IRC assessed using the Lugano 2014 Criteria start of new anti-cancer therapy, or death due to any cause, whichever occurs first
Measured: Up to 5 years from the last participant randomized
Time to next anti-cancer therapy (TTNLT)
Defined as time from randomization to start of new anti-cancer therapy or death due to any cause, whichever occurs first
Measured: Up to 5 years from the last participant randomized
PFS rate
Measured: Up to 5 years from the last participant randomized
EFS rate
Measured: Up to 5 years from the last participant randomized
OS rate
Measured: Up to approximately 7 years
Progression-free survival on the next line of treatment (PFS-2)
Defined as the time from randomization to death from any cause or tumor progression on next line treatment per Investigator assessment, whichever occurs first
Measured: Up to 5 years from the last participant randomized
Number of participants with adverse events (AEs)
Measured: Up to 5 years from the last participant randomized
Number of participants with adverse event of special interest (AESIs)
Measured: Up to 5 years from the last participant randomized
Number of participants with serious adverse events (SAEs)
Measured: Up to 5 years from the last participant randomized
Number of participants with laboratory abnormalities
Measured: Up to 5 years from the last participant randomized
Frequency and length of hospitalizations
Measured: Up to 5 years from the last participant randomized
Number of participants with intensive care unit (ICU) inpatient days
Measured: Up to 5 years from the last participant randomized
Number of participants with non-ICU inpatient days
Measured: Up to 5 years from the last participant randomized
Mean change from baseline in key health-related quality of life (HRQoL) domains.
Key HRQoL Domains:
Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)
Measured: Up to 5 years from the last participant randomized
Time to meaningful improvement/deterioration in key HRQoL domains.
Key HRQoL Domains:
Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)
Measured: Up to 5 years from the last participant randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start29 Mar 2024 (estimated)
- Primary completion16 Oct 2031 (estimated)
- Study completion16 Oct 2031 (estimated)
Why it stopped: Replaced with another clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313996
- Sponsor's protocol ID
- CA082-011
- Other IDs
- 2023-507477-18, 2023
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)
- ClinicalTrials.gov ID
- NCT06313996
- Acronym / sponsor ID
- CA082-011
- Keywords
- Lisocabtagene Maraleucel, Liso-cel, Follicular Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced with another clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- 29 Mar 2024 (estimated)
- Primary completion
- 16 Oct 2031 (estimated)
- Study completion
- 16 Oct 2031 (estimated)
- First posted
- 15 Mar 2024 (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 evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.
Detailed description
The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint.
The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria.
Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization.
Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Rituximab, Drug: Prednisone, Drug: Bendamustine, Drug: LenalidomideActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide) |
| Arm B | Experimental | Drug: Fludarabine, Drug: Liso-celLisocabtagene Maraleucel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have measurable disease.
- Participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants that have histologically confirmed Follicular Lymphoma (FL) (Grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening.
- Participants that have Relapsed or refractory FL, as assessed by the Investigator.
Key exclusion criteria (4 listed)
- Participants must not have any history of heart problems.
- Participants must not have any bleeding disorders.
- Participants must not have any Central Nervous System involvement by Follicular Lymphoma or other brain conditions.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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 |
|---|---|---|
| CyclophosphamideSpecified dose on specified days | Drug | Arm A |
| DoxorubicinSpecified dose on specified days | Drug | Arm A |
| VincristineSpecified dose on specified days | Drug | Arm A |
| RituximabSpecified dose on specified days | Drug | Arm A |
| PrednisoneSpecified dose on specified days | Drug | Arm A |
| BendamustineSpecified dose on specified days | Drug | Arm A |
| LenalidomideSpecified dose on specified days | Drug | Arm A |
| FludarabineSpecified dose on specified days | Drug | Arm B |
| Liso-celAlso: Lisocabtagene Maraleucel, BREYANZISpecified dose on specified days | Drug | Arm B |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 5 years from the last participant randomized
Defined as the time from randomization to death due to any cause or progressive disease (PD) per independent review committee (IRC) assessment using the Lugano 2014 Criteria, whichever occurs first
19 secondary outcomes
Complete response (CR)
Time frame: Up to 5 years from the last participant randomized
Overall survival (OS)
Time frame: Up to approximately 7 years
Overall response (OR)
Time frame: Up to 5 years from the last participant randomized
Duration of response (DOR)
Time frame: Up to 5 years from the last participant randomized
Event-free survival (EFS)
Time frame: Up to 5 years from the last participant randomized
Time to next anti-cancer therapy (TTNLT)
Time frame: Up to 5 years from the last participant randomized
PFS rate
Time frame: Up to 5 years from the last participant randomized
EFS rate
Time frame: Up to 5 years from the last participant randomized
OS rate
Time frame: Up to approximately 7 years
Progression-free survival on the next line of treatment (PFS-2)
Time frame: Up to 5 years from the last participant randomized
Number of participants with adverse events (AEs)
Time frame: Up to 5 years from the last participant randomized
Number of participants with adverse event of special interest (AESIs)
Time frame: Up to 5 years from the last participant randomized
Number of participants with serious adverse events (SAEs)
Time frame: Up to 5 years from the last participant randomized
Number of participants with laboratory abnormalities
Time frame: Up to 5 years from the last participant randomized
Frequency and length of hospitalizations
Time frame: Up to 5 years from the last participant randomized
Number of participants with intensive care unit (ICU) inpatient days
Time frame: Up to 5 years from the last participant randomized
Number of participants with non-ICU inpatient days
Time frame: Up to 5 years from the last participant randomized
Mean change from baseline in key health-related quality of life (HRQoL) domains.
Time frame: Up to 5 years from the last participant randomized
Time to meaningful improvement/deterioration in key HRQoL domains.
Time frame: Up to 5 years from the last participant randomized
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with Relapsed or Refractory Follicular Lymphoma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.
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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival (PFS) (time frame: Up to 5 years from the last participant randomized). 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 18 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.