CAR T-Cell Therapy for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether YESCARTA can be safely administered to individuals with specific types of lymphoma (a cancer of the lymphatic system) in an outpatient setting, allowing patients to avoid hospital stays. YESCARTA, a type of CAR T-cell therapy, uses modified immune cells to target and kill cancer cells. The study will monitor patients closely through physical exams, wearable devices, and telemedicine, ensuring hospital visits occur only when necessary. Suitable candidates for this trial include those with large B cell lymphoma unresponsive to previous treatments and who live within 30 miles of Vanderbilt. As a Phase 4 trial, YESCARTA has already received FDA approval and proven effective, and this research aims to understand how it benefits more patients.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have taken certain immunomodulating agents like checkpoint inhibitors, BTK inhibitors, and Revlimid within 2 months or 5 half-lives, whichever is shorter.
What is the safety track record for YESCARTA?
Research has shown that YESCARTA, a treatment for non-Hodgkin's lymphoma, has been tested in many patients. One study found that 90% of patients experienced a side effect called cytokine release syndrome (CRS), which can cause fever and chills, with about 9% of these cases being severe. This suggests that while YESCARTA can be effective, it often comes with side effects. Patients considering this treatment should be aware of these potential side effects, which are closely monitored in trials.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about YESCARTA (Axicabtagene Ciloleucel) for Non-Hodgkin's Lymphoma because it represents a cutting-edge approach using CAR T-cell therapy. Unlike traditional treatments like chemotherapy and radiation, which attack cancer cells indirectly, YESCARTA works by genetically modifying a patient's own T-cells to directly target and kill cancer cells. This personalized approach not only has the potential for higher effectiveness but also offers a rapidly acting solution, with patients receiving the therapy in just a single infusion. Additionally, YESCARTA's outpatient administration could significantly improve convenience and quality of life for patients compared to lengthy hospital stays associated with other treatments.
What is the effectiveness track record for YESCARTA in treating Non-Hodgkin's Lymphoma?
Research has shown that YESCARTA, which participants in this trial will receive, effectively treats non-Hodgkin's lymphoma. Patients receiving YESCARTA were more than twice as likely to remain free of major health events after two years compared to those on standard treatments. The overall survival rate for patients treated with YESCARTA was about 71%. Additionally, patients went an average of 14.6 months without their disease worsening. These results suggest YESCARTA is a promising option for treating non-Hodgkin's lymphoma.23678
Who Is on the Research Team?
Olalekan Oluwole, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Participants receive cyclophosphamide and fludarabine IV on days -5 to -3
Treatment
Participants receive YESCARTA IV infusion and are monitored closely in the outpatient setting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- YESCARTA
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
Kite, A Gilead Company
Industry Sponsor