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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

Ability to stay within approximately 30 miles of Vanderbilt for specific interventions

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, or refractory after ASCT at any time point

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can stay near Vanderbilt for treatments.

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My large B cell lymphoma or transformed follicular lymphoma has not responded well to at least two previous treatments including an anthracycline and a CD20-targeted therapy.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of treating participants with YESCARTA in the out patient setting

Measure time to specific interventions post infusion

Secondary outcome measures

Calculate cost of administering YESCARTA in the out-patient setting

Count of risk factors that preclude out-patient administration of YESCARTA

Measure cumulative steroid exposure

+1 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,908 Total Patients Enrolled

Kite, A Gilead CompanyIndustry Sponsor

43 Previous Clinical Trials

3,631 Total Patients Enrolled

Olalekan Oluwole, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center

Media Library

YESCARTA (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108805 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being accepted for this clinical experiment?

"This medical study is still enrolling participants according to information available on clinicaltrials.gov, which initially posted the trial in December of 2021 and revised it last September."

Answered by AI

What is the uppermost capacity of participants in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial – which was posted on December 2nd 2021 – is actively recruiting patients today. Currently, 20 individuals are being recruited from a single medical centre."

Answered by AI

Is there an opportunity to enroll in this experiment?

"This trial is seeking to enrol 20 individuals, aged 18-75 years old, who have been diagnosed with large B cell lymphoma. To qualify for the study, applicants need to meet a set of criteria including: being in an ECOG performance status between 0 and 2; having neutrophils (ANC) greater than 1000/µL and platelets more than 75000/ µL; bilirubin lower than 1.5 mg/dL ;creatinine clearance higher or equal 60 mL per min per 1.73 m2; cardiac ejection fraction no less 50%; must be chemotherapy refractory disease evidenced by"

Answered by AI

Is this experimental program open to adults aged 35 and older?

"According to eligibility criteria, only participants aged between 18 and 75 are applicable for this clinical trial. There are 305 studies aiming at younger individuals while 1612 trials focus on those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

Olalekan Oluwole 2021. "Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05108805.

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