Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCA... | NCT05108805

Name	Class
Kite, A Gilead Company	INDUSTRY

Description Module

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

Label	Type	Description	Intervention Names
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.	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

Name	Type	Description	Arm Group Labels	Other Names
Telemedicine Visit	Procedure	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.

Measure	Description	Time Frame
Number of Participants That Received YESCARTA	The number of participants that received YESCARTA as outpatient therapy	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	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	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	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	at 30 days

Measure	Description	Time Frame
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	Approximately 30 days
Participants That Experienced Cytokine Release Syndrome Events

Eligibility Module

Eligibility Criteria

Inclusion Criteria (before leukapheresis)

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.

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

Refractory after autologous stem cell transplant (ASCT) at any time point

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.

Exclusion Criteria:

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.

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.

Name	Affiliation	Role
Olalekan Oluwole, MD	Vanderbilt-Ingram Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt-Ingram Cancer Center		Nashville	Tennessee	37232	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 5, 2023

Arm/Group Information

ID	Title	Description
BG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Units	Counts
Participants	BG00025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants That Received YESCARTA

The number of participants that received YESCARTA as outpatient therapy

Posted

Count of Participants

Participants

Approximately 6 weeks

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Units	Counts
Participants	OG00020

Title

Denominators

Categories

Title	Measurements
	OG00020

Primary

Participants That Required Hospitalization at 72 Hours Post Infusion

Number of subjects that were admitted to hospital at 72 hours post infusion

Posted

Count of Participants

Participants

at 72 hours

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Primary

Participants That Required Hospitalization at 7 Days Post Infusion

Number of subjects that were admitted to the hospital at 7 days post infusion

Posted

Count of Participants

Participants

at 7 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Primary

Participants That Required Hospitalization at 14 Days Post Infusion

Number of subjects that were admitted to the hospital at 14 days post infusion

Posted

Count of Participants

Participants

at 14 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Primary

Participants That Required Hospitalization at 30 Days Post Infusion

Number of subjects that were admitted to hospital at 30 days post infusion

Posted

Count of Participants

Participants

at 30 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Units

Secondary

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

This analysis includes all participants who consented to the study but did not receive YESCARTA as planned. Reasons the participants did not receive YESCARTA are listed.

Posted

Count of Participants

Participants

Approximately 30 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Secondary

Participants That Experienced Cytokine Release Syndrome Events

Count of participants that had cytokine release syndrome events

Posted

Count of Participants

Participants

Approximately 30 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Units

Secondary

Participants That Experienced Immune Effector Cell-associated Neurotoxicity Syndrome Events

Count of participants that had an immune effector cell-associated neurotoxicity syndrome event

Posted

Count of Participants

Participants

Approximately 30 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Secondary

Incidence of Steroid Administration During YESCARTA

Count of participants that were administered steroids during treatment

Posted

Count of Participants

Participants

Approximately 30 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Units

Secondary

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.

This was the total cost per patient for administering Yescarta on study.

Posted

Number

dollars

Approximately 30 days

ID	Title	Description
OG000	YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting	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. Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, 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 measurements: 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 Visit: Physical exam and review of all available data Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV Cyclophosphamide: Given IV Fludarabine: Given IV

Term	Organ System	Assessment Type	Statistical Information
Supraventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected25 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected25 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected25 at risk
Fever	General disorders	Systematic Assessment	EG0002 events2 affected25 at risk
Cytokine release syndrome	Immune system disorders	Systematic Assessment	EG0001 events1 affected25 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected25 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected25 at risk

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0008 events3 affected25 at risk
White Blood Cell Decrease	Blood and lymphatic system disorders	Systematic Assessment	EG0006 events3 affected25 at risk
Neutrophil Count Decrease	Investigations	Systematic Assessment	EG00023 events10 affected25 at risk
Fatique	General disorders	Systematic Assessment	EG0009 events8 affected25 at risk
Fever	General disorders	Systematic Assessment	EG00019 events16 affected25 at risk
Platelet Count Decreased	Investigations	Systematic Assessment	EG0003 events3 affected25 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected25 at risk
Sinus Tachycardia	Cardiac disorders	Systematic Assessment	EG0002 events2 affected25 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0008 events6 affected25 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected25 at risk
Cognitive Disturbance	Nervous system disorders	Systematic Assessment	EG0002 events2 affected25 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0006 events4 affected25 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0003 events3 affected25 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected25 at risk
Non-Cardiac Chest Pain	General disorders	Systematic Assessment	EG0002 events2 affected25 at risk
Cytokine Release Syndrome	Immune system disorders	Systematic Assessment	EG00026 events15 affected25 at risk

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D001794	Blood Pressure
C000629083	axicabtagene ciloleucel
D003520	Cyclophosphamide
C024352	fludarabine
C042382	fludarabine phosphate

ID	Term
D055986	Vital Signs
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006439	Hemodynamics
D002320	Cardiovascular Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds