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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Duration of response (DOR) as Assessed by Investigator Assessment

+5 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Cerebrospinal fluid leak

Deep Vein Thrombosis

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

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: 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

Dexamethasone

2007

Completed Phase 4

~2650

Fludarabine

2012

Completed Phase 4

~1830