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CAR T-cell Therapy

Axicabtagene Ciloleucel for Non-Hodgkin's Lymphoma (ZUMA-5 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

Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma

Individual has follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy (e.g. R-bendamustine, R-CHOP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

ZUMA-5 Trial Summary

This trial will enroll 160 adults with relapsed or refractory non-Hodgkin's lymphoma. Subjects will receive axicabtagene ciloleucel, an experimental product made from the subject's own genetically-modified white blood cells. The goal is to determine if the product is safe and effective.

Who is the study for?

Adults with relapsed or refractory indolent Non-Hodgkin Lymphoma, specifically follicular lymphoma or marginal zone lymphoma that worsened after at least two prior treatments. Participants must have measurable disease, no CNS lymphoma involvement, and be able to stop current therapies before leukapheresis. They should be in good physical condition (ECOG 0-1) and not pregnant or breastfeeding.Check my eligibility

What is being tested?

The trial is testing axicabtagene ciloleucel, a treatment made from the patient's own genetically modified white blood cells designed to fight cancer. It also involves pre-treatment with Cyclophosphamide and Fludarabine. The goal is to see if this approach is effective (aiming for a 70% response rate) and safe for patients.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, fever, fatigue, neurological events like confusion or seizures, low blood cell counts leading to increased infection risk or bleeding problems, and possible allergic reactions due to the body's response to genetically modified cells.

ZUMA-5 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma has not affected my brain or spinal cord.

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My lymphoma has worsened after two or more treatments.

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My cancer can be measured by tests.

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I am mostly active and have good kidney, liver, lung, and heart function.

ZUMA-5 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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

Objective response rate per central read

Secondary outcome measures

Best Objective Response per Central Read or Investigator Read

CR Rate per central read

Complete response rate among those participants with 3 or more lines of prior therapy

+11 more

ZUMA-5 Trial Design

1Treatment groups

Experimental Treatment

Group I: axicabtagene ciloleucelExperimental Treatment3 Interventions

Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of CAR transduced autologous T cells.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Cyclophosphamide

1995

Completed Phase 3

~3780

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor

43 Previous Clinical Trials

3,497 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

28 Previous Clinical Trials

2,855 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03105336 — Phase 2

Follicular Lymphoma Research Study Groups: axicabtagene ciloleucel

Follicular Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT03105336 — Phase 2

Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03105336 — Phase 2

Frequently Asked Questions

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

How many venues is this experiment currently taking place in?

"Currently, 17 medical facilities are hosting this clinical trial. In addition to Seattle, Gilbert and Miami, there are 14 additional sites. To best accommodate your needs, it is important that you choose the closest clinic when deciding whether or not to join the study."

Answered by AI

Are there any openings remaining for participants in this trial?

"Clinicaltrials.gov indicates that, as of this moment, the trial is not currently accepting applications. This study was initially posted on June 20th 2017 and most recently updated November 22nd 2022; however, 2644 other medical studies are still accepting participants at present."

Answered by AI

Could you elucidate what other tests have been undertaken with axicabtagene ciloleucel?

"Currently, 894 active clinical trials are being conducted in order to further research axicabtagene ciloleucel. Of those studies, 161 have reached Phase 3 status. Furthermore, 28479 locations across the globe are researching this treatment with the majority of them located in Philadelphia, Pennsylvania."

Answered by AI

What precautions should be taken when using axicabtagene ciloleucel?

"As axicabtagene ciloleucel is only in Phase 2, the limited data available suggests it has a relatively high safety profile. Thus, our team at Power rated it as a level 2 on their scale of 1 to 3."

Answered by AI

In what clinical contexts is axicabtagene ciloleucel commonly employed?

"Axicabtagene ciloleucel can be employed therapeutically to treat a variety of diseases, such as lung cancer, multiple sclerosis and acute myelocytic leukemia."

Answered by AI

How many individuals are currently enrolled in this experiment?

"At the present time, this investigation is not actively recruiting participants. It was initially posted on June 20th 2017 and last updated November 22nd 2022. Other studies in related fields include 1,750 trials for those with lymphoma and 894 involving axicabtagene ciloleucel that are currently looking for patients to take part."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Axicabtagene Ciloleucel in Relapsed or Refractory Indolent Non-hodgkin Lymphoma (ZUMA-5): A Single-arm, Multicentre, Phase 2 Trial

Jacobson, Caron A, Julio C Chavez, Alison R Sehgal, Basem M William, Javier Munoz, Gilles Salles, Pashna N Munshi, et al.. 2022. “Axicabtagene Ciloleucel in Relapsed or Refractory Indolent Non-hodgkin Lymphoma (ZUMA-5): A Single-arm, Multicentre, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00591-x.

The Lancet OncologyJournal

Axicabtagene Ciloleucel in Relapsed or Refractory Indolent Non-hodgkin Lymphoma (ZUMA-5): A Single-arm, Multicentre, Phase 2 Trial

BloodJournal

Comparative Effectiveness of ZUMA-5 (axi-cel) Vs SCHOLAR-5 External Control in Relapsed/refractory Follicular Lymphoma

Ghione, Paola, M. Lia Palomba, Anik R. Patel, Sabela Bobillo, Kevin Deighton, Caron A. Jacobson, Myrna Nahas, et al.. 2022. “Comparative Effectiveness of ZUMA-5 (axi-cel) Vs SCHOLAR-5 External Control in Relapsed/refractory Follicular Lymphoma”. Blood. American Society of Hematology. doi:10.1182/blood.2021014375.

clinicaltrials.govStudy

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma