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CAR T-cell Therapy
CAR T-Cell Therapy for Non-Hodgkin's Lymphoma
N/A
Waitlist Available
Led By Olalekan Oluwole, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Subjects with detectable cerebrospinal fluid malignant cells, brain metastases, or history of CNS disorders
History of allogeneic stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a new cancer treatment can be given safely to patients outside of a hospital.
Who is the study for?
This trial is for adults over 18 with large B cell lymphoma or transformed follicular lymphoma that's relapsed after two therapies, including anthracycline and CD20-targeted therapy. Participants need good organ function, a caregiver to help monitor their health, and the ability to use telemedicine tools. They can't join if they've had prior CAR T-cell therapy, certain infections like HIV or hepatitis, CNS lymphoma involvement, severe allergies to study drugs, are pregnant/breastfeeding without birth control measures in place, have autoimmune diseases requiring treatment within the last 2 years or other conditions that might interfere with the study.
What is being tested?
The trial tests whether YESCARTA CAR T-cell therapy can be safely given outside of a hospital by using close monitoring through physical exams, wearable devices for vital signs tracking and telemedicine support. Patients will only be admitted if they meet specific criteria indicating more intensive care is needed.
What are the potential side effects?
Potential side effects from YESCARTA may include symptoms related to immune system activation such as fever and fatigue; neurological events like confusion or seizures; low blood cell counts leading to increased infection risk; allergic reactions during infusion; and potential impact on liver enzymes.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastases, CNS disorders, or cancer cells in my cerebrospinal fluid.
Select...
I have had a stem cell transplant from a donor.
Select...
I am pregnant or breastfeeding.
Select...
My lymphoma affects my heart's atrium or ventricle.
Select...
I am not willing to use birth control.
Select...
I need immediate treatment because my tumor is causing symptoms.
Select...
My CLL has transformed into a more aggressive form.
Select...
I have previously received CAR T-cell therapy or similar treatments.
Select...
My tumor does not have the CD19 marker.
Select...
I have been cancer-free for 3 years, except for nonmelanoma skin cancer or carcinoma in situ.
Select...
I am currently on IV antibiotics for an uncontrolled infection.
Select...
I had a stem cell transplant for treatment within the last 6 weeks.
Select...
I have a history of HIV or hepatitis B/C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of treating participants with YESCARTA in the out patient setting
Secondary study objectives
Measure effectiveness of close monitoring of participants in the out-patient setting
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: YESCARTA in the Outpatient SettingExperimental Treatment4 Interventions
Participants will receive YESCARTA therapy in the outpatient setting
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telemedicine Visit
2017
N/A
~20
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
218 Previous Clinical Trials
64,331 Total Patients Enrolled
Kite, A Gilead CompanyIndustry Sponsor
44 Previous Clinical Trials
3,934 Total Patients Enrolled
Olalekan Oluwole, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.