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CAR T-cell Therapy
Axicabtagene Ciloleucel for Large B-Cell Lymphoma (ZUMA-24 Trial)
Phase 2
Waitlist Available
Research Sponsored by Kite, A Gilead Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
ZUMA-24 Trial Summary
This trial is testing a new treatment for people with a certain type of lymphoma that has come back or didn't respond to other treatments. They are testing to see how well it works and what side effects it has.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests axicabtagene ciloleucel given alongside steroids like dexamethasone in patients with large B-cell lymphoma that has come back after treatment or hasn't responded to it. The aim is to see how well the drug works when administered outside the hospital setting.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to symptoms such as fever and fatigue; neurological issues like confusion; low blood cell counts increasing infection risk; and infusion-related reactions which may cause nausea, chills, fever.
ZUMA-24 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage and Severity of Participants with Treatment-emergent Cytokine Release Syndrome (CRS) and Neurologic Events
Secondary outcome measures
Blood Levels of Axicabtagene Ciloleucel Chimeric Antigen Receptor (CAR) T-cells Over Time
Change in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L) From Baseline to Month 6
Complete Response (CR) Rate as Assessed by Investigator Assessment
+21 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
ZUMA-24 Trial Design
1Treatment groups
Experimental Treatment
Group I: Axicabtagene CiloleucelExperimental Treatment4 Interventions
Participant will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m^2/day and fludarabine 30 mg/m^2/day) over 3 days (Days -5, -4, and -3) followed by prophylactic corticosteroid treatment with 10 mg dexamethasone on Day 0 (prior to axicabtagene ciloleucel), Day 1, and Day 2.
Participant will receive axicabtagene ciloleucel consisting of a single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells on Day 0 (following dexamethasone 10 mg) at a target dose of 2 x 10^6 cells/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Dexamethasone
2007
Completed Phase 4
~2590
Axicabtagene Ciloleucel
2015
Completed Phase 2
~500
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,621 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,979 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant using my own or donor cells.I have or had cancer cells in my brain or spinal fluid.I have had CAR-T cell therapy or similar treatments.I have previously received therapy targeting CD19.I've been treated with both an Anti-CD20 drug and anthracycline-based chemotherapy.I have a specific type of advanced lymphoma and have undergone at least one treatment.I am fully active or restricted in physically strenuous activity but can do light work.I agree to follow the treatment and monitoring plan as an outpatient.I have an infection that needs strong antibiotics or antifungals.
Research Study Groups:
This trial has the following groups:- Group 1: Axicabtagene Ciloleucel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for participants in this research?
"This study is recruiting participants, as indicated on clinicaltrials.gov. The trial was originally posted on 8/10/2022 and was last updated on 11/2/2022."
Answered by AI
Are there any risks associated with taking Dexamethasone?
"Because Dexamethasone is only in Phase 2 testing, there is not yet clinical data supporting its efficacy. However, it has been shown to be safe thus far and was given a score of 2."
Answered by AI
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