Large B-cell LymphomaPhase 4NCT05108805
Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
A Phase 4 study testing Telemedicine Visit, Vital sign measurements and Out-Patient Clinic Visit in people with Large B-cell Lymphoma and Diffuse Large B-cell Lymphoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Large B-cell Lymphoma, Diffuse Large B-cell Lymphoma
- What is being tested?
- Telemedicine Visit, Vital sign measurements and Out-Patient Clinic Visit
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 8 Dec 2023
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and above
- Histologically proven large B cell lymphoma or transformed follicular lymphoma to DLBCL in relapse/refractory after two lines of therapies which included an anthracycline and CD20-targeted therapy.
- Or
- Chemotherapy refractory disease evidenced by lack of adequate response to first line therapy. This consists of either progressive disease as best response to first line therapy or stable disease as best response after 4 cycles of appropriate chemotherapy
- Or
- Refractory after autologous stem cell transplant (ASCT) at any time point
Show all 22Show fewer
- And
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate hematologic, hepatic, renal and cardiac function evidenced by:
- absolute neutrophil count (ANC) ≥1000/µL
- Platelet ≥ 75,000/ µL
- T-bilirubin ≤ 1.5 mg/dL
- Normal serum creatinine or creatinine clearance ≥ 60 mL/min/1.73 m2
- Cardiac ejection fraction ≥ 50%
- Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 5 times upper limit of normal (ULN).
- At least 1 measurable lesion
- Baseline oxygen saturation ≥92% on room air.
- Ability to stay at a distance which allows for subjects to come in and for specific interventions like antibiotics and tocilizumab to be started in 1 hour or less. This is approximately 30 miles of Vanderbilt.
- A caregiver who can be educated to operate equipment for vital signs monitoring.
- Caregiver Eligibility:
- Willingness to serve as a caregiver Ability to read, write and operate a phone Willingness to be taught to operate electronic device Willingness and ability to assist subject to wear electronic device such including patch, blood pressure machine, thermometer Pass caregiver assessment test
- Subject and caregiver willing to be taught to operate an iPad or other electronic media for telemedicine, use wearable devices, and pass the caregiver competence test.
Who cannot join
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.
- Known CD19 negative tumor.
- History of Richter's transformation of chronic lymphocytic leukemia (CLL).
- Autologous stem cell transplant with therapeutic intent within 6 weeks of planned YESCARTA infusion.
- History of allogeneic stem cell transplantation.
- Prior CAR therapy or other genetically modified T-cell therapy.
Show all 24Show fewer
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor.
- History of human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or hepatitis C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines or applicable country guidelines.
- Presence of any in-dwelling line or drain (e.g., percutaneous nephrostomy tube, in-dwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted.
- Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases. Patients with treated secondary CNS involvement of lymphoma are allowed.
- History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, progressive multifocal leukoencephalopathy, or any autoimmune disease with CNS involvement if it impairs ability to complete an effective and reliable neurological assessment.
- Subjects with cardiac atrial or cardiac ventricular lymphoma involvement.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment.
- Requirement for urgent therapy due to tumor mass effects (e.g., blood vessel compression, bowel obstruction, or transmural gastric involvement).
- Primary immunodeficiency.
- Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.
- Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
- Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy.
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
- History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- Must not have received immunomodulating agents including checkpoint inhibitors, Bruton tyrosine kinase (BTK) inhibitors, and Revlimid within 2 months or 5 half-lives whichever is shorter.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria
Read the detailed description
Primary Objectives
- To explore the feasibility of treating subjects with YESCARTA in the outpatient setting and guide the development of a subsequent, larger study that will determine the tolerability and safety profile of YESCARTA in the outpatient setting.
- To determine the time to specific interventions post infusion and the number of subjects who remain outpatient through 72 hours, 7, 14, and 30 days.
Secondary Objectives:
- Identify risk factors that preclude outpatient administration, and to obtain clinical data that will guide the development of guidelines by which YESCARTA treatment in the outpatient setting can be done safely.
- Assess the impact of close monitoring with telemedicine and twice-daily physical exam on specific outcomes including CRS and ICANS in subjects treated with YESCARTA in the outpatient setting.
- Cumulative steroid exposure within 28 days post YESCARTA infusion.
- To calculate the estimated cost of YESCARTA administered in the outpatient setting.
Exploratory Objectives:
- Time from YESCARTA infusion to the following: fever, fever with neutropenia, fever without neutropenia.
- Time from fever to Tocilizumab, fever to ICU admission, fever to low BP, fever to IV Fluid, fever to vasopressor, fever to onset to arrhythmias and fever to hospitalization.
- Calculate modified Neutropenic Fever Symptom Burden (NFSB) score for days 1-3 for each subject. Appendix D
- Obtain subject reported outcomes measured by Subject-Reported Outcomes Measurement Information System (PROMIS; Appendix F) [16, 17]
- Feasibility of using wearable devices to monitor vital signs in the outpatient setting. Data collected are for research only
- Being tested
- Telemedicine Visit, Vital sign measurements, Out-Patient Clinic Visit, Blood pressure and pulse oximeter, Axicabtagene Ciloleucel
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine VisitProcedure or surgery
A remote telemedicine visit with audio and video, using the internet with a nurse practitioner (NP) located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, heart rate (HR), respiration rate (RR), SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurementsProcedure or surgery
Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic VisitProcedure or surgery
Physical exam and review of all available data
Blood pressure and pulse oximeterProcedure or surgery
Participant and their family take their blood pressure and pulse oximeter
Axicabtagene CiloleucelBiological
Axicabtagene Ciloleuce given by IV
CyclophosphamideDrug
Also called Cyclophosphamide 500 mg/m^2/day, Cytoxan®
Given IV
FludarabineDrug
Also called Fludarabine 30 mg/m^2/day, Fludara®
Given IV
| Study group | Role | What they receive |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | Experimental | Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity. Receives: Procedure: Telemedicine Visit; Procedure: Vital sign measurements; Procedure: Out-Patient Clinic Visit; Procedure: Blood pressure and pulse oximeter; Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Received YESCARTA
The number of participants that received YESCARTA as outpatient therapy
Measured: Approximately 6 weeks
Participants That Required Hospitalization at 72 Hours Post Infusion
Number of subjects that were admitted to hospital at 72 hours post infusion
Measured: at 72 hours
Participants That Required Hospitalization at 7 Days Post Infusion
Number of subjects that were admitted to the hospital at 7 days post infusion
Measured: at 7 days
Participants That Required Hospitalization at 14 Days Post Infusion
Number of subjects that were admitted to the hospital at 14 days post infusion
Measured: at 14 days
Participants That Required Hospitalization at 30 Days Post Infusion
Number of subjects that were admitted to hospital at 30 days post infusion
Measured: at 30 days
Secondary outcomes (5)
Count of Risk Factors That Preclude Out-patient Administration of YESCARTA
Reasons as to why a participant did not receive YESCARTA in the out-patient setting
Measured: Approximately 30 days
Participants That Experienced Cytokine Release Syndrome Events
Count of participants that had cytokine release syndrome events
Measured: Approximately 30 days
Participants That Experienced Immune Effector Cell-associated Neurotoxicity Syndrome Events
Count of participants that had an immune effector cell-associated neurotoxicity syndrome event
Measured: Approximately 30 days
Incidence of Steroid Administration During YESCARTA
Count of participants that were administered steroids during treatment
Measured: Approximately 30 days
Cost Per Patient of Administering YESCARTA in the Out-patient Setting
Cost includes hospital clinic charges and CAR-T acquisition. It was pre-specified to report a single dollar amount that every participant was changed. The amount entered was the amount that each patient was charged. It was not planned to assess this amount separately for each participant.
Measured: Approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start2 Dec 2021
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
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 Large B-cell LymphomaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kite, A Gilead Company
- Responsible party
- Principal investigator, Olalekan Oluwole, Vanderbilt-Ingram Cancer Center
- Investigators
- Olalekan Oluwole, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108805
- Sponsor's protocol ID
- VICC CTT 2109
- Status last verified
- Mar 2025
- First submitted
- 29 Oct 2021
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT05108805
- Acronym / sponsor ID
- VICC CTT 2109
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- Kite, A Gilead Company
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria
Detailed description
Primary Objectives
- To explore the feasibility of treating subjects with YESCARTA in the outpatient setting and guide the development of a subsequent, larger study that will determine the tolerability and safety profile of YESCARTA in the outpatient setting.
- To determine the time to specific interventions post infusion and the number of subjects who remain outpatient through 72 hours, 7, 14, and 30 days.
Secondary Objectives:
- Identify risk factors that preclude outpatient administration, and to obtain clinical data that will guide the development of guidelines by which YESCARTA treatment in the outpatient setting can be done safely.
- Assess the impact of close monitoring with telemedicine and twice-daily physical exam on specific outcomes including CRS and ICANS in subjects treated with YESCARTA in the outpatient setting.
- Cumulative steroid exposure within 28 days post YESCARTA infusion.
- To calculate the estimated cost of YESCARTA administered in the outpatient setting.
Exploratory Objectives:
- Time from YESCARTA infusion to the following: fever, fever with neutropenia, fever without neutropenia.
- Time from fever to Tocilizumab, fever to ICU admission, fever to low BP, fever to IV Fluid, fever to vasopressor, fever to onset to arrhythmias and fever to hospitalization.
- Calculate modified Neutropenic Fever Symptom Burden (NFSB) score for days 1-3 for each subject. Appendix D
- Obtain subject reported outcomes measured by Subject-Reported Outcomes Measurement Information System (PROMIS; Appendix F) [16, 17]
- Feasibility of using wearable devices to monitor vital signs in the outpatient setting. Data collected are for research only
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | Experimental | Procedure: Telemedicine Visit, Procedure: Vital sign measurements, Procedure: Out-Patient Clinic Visit, Procedure: Blood pressure and pulse oximeter, Biological: Axicabtagene Ciloleucel, Drug: Cyclophosphamide, Drug: FludarabinePatients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 18 years and above
- Histologically proven large B cell lymphoma or transformed follicular lymphoma to DLBCL in relapse/refractory after two lines of therapies which included an anthracycline and CD20-targeted therapy.
- Or
- Chemotherapy refractory disease evidenced by lack of adequate response to first line therapy. This consists of either progressive disease as best response to first line therapy or stable disease as best response after 4 cycles of appropriate chemotherapy
- Or
Key exclusion criteria (24 listed)
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.
- Known CD19 negative tumor.
- History of Richter's transformation of chronic lymphocytic leukemia (CLL).
- Autologous stem cell transplant with therapeutic intent within 6 weeks of planned YESCARTA infusion.
- History of allogeneic stem cell transplantation.
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 |
|---|---|---|
| Telemedicine VisitA remote telemedicine visit with audio and video, using the internet with a nurse practitioner (NP) located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, heart rate (HR), respiration rate (RR), SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated. | Procedure or surgery | YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting |
| Vital sign measurementsParticipant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit. | Procedure or surgery | YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting |
| Out-Patient Clinic VisitPhysical exam and review of all available data | Procedure or surgery | YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting |
| Blood pressure and pulse oximeterParticipant and their family take their blood pressure and pulse oximeter | Procedure or surgery | YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting |
| Axicabtagene CiloleucelAxicabtagene Ciloleuce given by IV | Biological | YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting |
| CyclophosphamideAlso: Cyclophosphamide 500 mg/m^2/day, Cytoxan®Given IV | Drug | YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting |
| FludarabineAlso: Fludarabine 30 mg/m^2/day, Fludara®Given IV | Drug | YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting |
Primary outcome
Number of Participants That Received YESCARTA
Time frame: Approximately 6 weeks
The number of participants that received YESCARTA as outpatient therapy
Participants That Required Hospitalization at 72 Hours Post Infusion
Time frame: at 72 hours
Number of subjects that were admitted to hospital at 72 hours post infusion
Participants That Required Hospitalization at 7 Days Post Infusion
Time frame: at 7 days
Number of subjects that were admitted to the hospital at 7 days post infusion
Participants That Required Hospitalization at 14 Days Post Infusion
Time frame: at 14 days
Number of subjects that were admitted to the hospital at 14 days post infusion
Participants That Required Hospitalization at 30 Days Post Infusion
Time frame: at 30 days
Number of subjects that were admitted to hospital at 30 days post infusion
5 secondary outcomes
Count of Risk Factors That Preclude Out-patient Administration of YESCARTA
Time frame: Approximately 30 days
Participants That Experienced Cytokine Release Syndrome Events
Time frame: Approximately 30 days
Participants That Experienced Immune Effector Cell-associated Neurotoxicity Syndrome Events
Time frame: Approximately 30 days
Incidence of Steroid Administration During YESCARTA
Time frame: Approximately 30 days
Cost Per Patient of Administering YESCARTA in the Out-patient Setting
Time frame: Approximately 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Large B-cell Lymphoma
Active, not recruitingPhase 2
Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
Active, not recruitingPhase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Active, not recruitingPhase 2/3
Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas
Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingPhase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma
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.
Olalekan Oluwole, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telemedicine Visit, Vital sign measurements and Out-Patient Clinic Visit in people with Large B-cell Lymphoma and Diffuse Large B-cell Lymphoma, run by Vanderbilt-Ingram Cancer Center 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 22 inclusion and 24 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: finished, as of the sponsor's last update on 27 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Mar 2025). 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?
Number of Participants That Received YESCARTA (time frame: Approximately 6 weeks). The study lists 5 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 27 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.