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CAR T-cell Therapy

Axicabtagene Ciloleucel for Lymphoma (ZUMA-23 Trial)

Phase 3

Recruiting

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 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a new product, axi-cel, to see if it is safe and effective for treating lymphoma compared to existing treatments.

Who is the study for?

This trial is for adults with high-risk large B-cell lymphoma, confirmed by local pathology. Participants must have an IPI score of 4 or 5, only one prior cycle of R-chemotherapy, and good organ function. Excluded are those with certain subtypes of LBCL, CNS involvement, severe allergies to study drugs, active hepatitis B/C or HIV not well-controlled on medication.

What is being tested?

The trial compares axicabtagene ciloleucel (a new therapy) against the standard care which includes a combination of chemotherapy drugs like Vincristine and Doxorubicin for first-line treatment in participants with high-risk large B-cell lymphoma.

What are the potential side effects?

Potential side effects include immune system reactions that can affect normal cells while targeting cancer cells, infusion-related symptoms such as fever or chills, blood cell count changes leading to increased infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Event-free Survival (EFS) by Blinded Central Assessment

Secondary study objectives

Lymphoma, Non-Hodgkin

Malignant Neoplasms

Change From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Axicabtagene CiloleucelExperimental Treatment3 Interventions

Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepletion chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.

Group II: Standard of Care TherapyActive Control6 Interventions

Participants will receive the investigator's choice of one of the following therapies/dosing schedules: * Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for a total of 6 cycles (21-day cycle) * Rituximab 375 mg/m\^2 on Day 1 * Cyclophosphamide 750 mg/m\^2 on Day 1 * Doxorubicin 50 mg/m\^2 on Day 1 * Vincristine 1.4 mg/m\^2 (maximum 2 mg) on Day 1 * Prednisone 40 mg/m\^2 on Day 1 through Day 5 * Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) for a total of 6 cycles (21-day cycle) * Rituximab 375 mg/m\^2 on Day 1 * Etoposide 50 mg/m\^2 on Days 1 to 4 * Doxorubicin 10 mg/m\^2 on Days 1 to 4 * Vincristine 0.4 mg/m\^2 on Days 1 to 4 * Cyclophosphamide 750 mg/m\^2 on Day 5 * Prednisone 60 mg/m\^2 twice daily on Days 1 to 5

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axicabtagene Ciloleucel

2020

Completed Phase 2

~510

Fludarabine

2012

Completed Phase 4

~1830