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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

ZUMA-23 Trial 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.Check my eligibility

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.See study design

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.

ZUMA-23 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free Survival (EFS) by Blinded Central Assessment

Secondary outcome measures

Lymphoma, Non-Hodgkin

Malignant Neoplasms

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

+6 more

ZUMA-23 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

Fludarabine

2012

Completed Phase 3

~1100

Axicabtagene Ciloleucel

2015

Completed Phase 2

~490

Cyclophosphamide

1995

Completed Phase 3

~3770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor

43 Previous Clinical Trials

3,356 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

28 Previous Clinical Trials

2,714 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05605899 — Phase 3

B-Cell Lymphoma Research Study Groups: Standard of Care Therapy, Axicabtagene Ciloleucel

B-Cell Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT05605899 — Phase 3

Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05605899 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How hazardous is the administration of Axicabtagene Ciloleucel for human patients?

"Due to the clinical data that has been collected, our team at Power assigned Axicabtagene Ciloleucel a score of 3 in terms of safety. This is largely because it is currently being tested during Phase 3 trials and demonstrating efficacy as well as sustained safety profiles."

Answered by AI

How many participants are signing up for this research experiment?

"The sponsor, Kite, A Gilead Company, needs to recruit 300 individuals who meet the pre-defined criteria for this trial. The study is expected to take place at Tennessee Oncology, PLLC in Nashville and The University of Texas' MD Anderson Cancer Center in Houston."

Answered by AI

Is there still an opportunity to enroll in this clinical experiment?

"Affirmative. According to the data found on clinicaltrials.gov, this medical research is actively searching for volunteers. The initial posting date was February 1st 2023 and the most recent update happened on June 2nd of that same year. Across three locations, 300 participants are being sought out for recruitment purposes."

Answered by AI