Axicabtagene Ciloleucel for Large B-Cell Lymphoma
(ZUMA-24 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What safety data exists for Axicabtagene Ciloleucel (Yescarta) in humans?
Axicabtagene ciloleucel, a CAR T-cell therapy, can cause cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which are complications that affect the immune and nervous systems. These side effects can be serious, and managing them effectively is still a challenge.12345
What makes the drug Axicabtagene Ciloleucel unique for treating Large B-Cell Lymphoma?
What data supports the effectiveness of the treatment Axicabtagene Ciloleucel for Large B-Cell Lymphoma?
Research shows that Axicabtagene Ciloleucel (Yescarta) is effective for patients with relapsed or refractory large B-cell lymphoma, with significant and durable clinical benefits observed in clinical trials. It has been approved by the FDA for this condition due to its high response rates, although it can have serious side effects that need careful management.1112131415
Who Is on the Research Team?
Kite Study Director
Principal Investigator
Kite, A Gilead Company
Are You a Good Fit for This Trial?
This trial is for adults with relapsed or refractory large B-cell lymphoma who have had prior treatments including an anti-CD20 monoclonal antibody and chemotherapy. They must have at least one measurable lesion, be in good physical condition (ECOG status of 0 or 1), and agree to outpatient treatment. Excluded are those with a history of stem cell transplant, previous CAR T-cell therapy, CNS involvement by lymphoma, more than one line of LBCL therapy, or uncontrolled infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine over 3 days
Treatment
Participants receive axicabtagene ciloleucel infusion following prophylactic corticosteroid treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants who complete at minimum 24 months follow-up will transition to a separate long-term follow-up study
What Are the Treatments Tested in This Trial?
Interventions
- Axicabtagene Ciloleucel
- Cyclophosphamide
- Dexamethasone
- Fludarabine
Axicabtagene Ciloleucel is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kite, A Gilead Company
Lead Sponsor