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CAR T-cell Therapy

Axicabtagene Ciloleucel for Lymphoma (ZUMA-7 Trial)

Phase 3

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

Individuals must have received adequate first-line therapy including anti-CD20 monoclonal antibody and an anthracycline containing chemotherapy regimen

No known history or suspicion of central nervous system involvement by lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

ZUMA-7 Trial Summary

This trial will compare axicabtagene ciloleucel therapy to standard second-line therapy for treating patients with DLBCL that has returned or does not respond to initial treatment.

Who is the study for?

This trial is for adults with a type of cancer called diffuse large B-cell lymphoma that has returned or didn't respond to initial treatment. They must have had only one prior therapy, be in fairly good health, and not have cancer outside the lymph system or certain other medical conditions.Check my eligibility

What is being tested?

The study compares axicabtagene ciloleucel (a CAR-T cell therapy) with standard second-line treatments including salvage chemotherapy and stem cell transplant. The aim is to see if this new approach works better for patients whose disease came back or resisted treatment.See study design

What are the potential side effects?

Axicabtagene ciloleucel can cause immune system reactions, fever, difficulty breathing, feeling tired, confusion, nausea. Chemotherapy may lead to hair loss, mouth sores, increased infection risk and fatigue.

ZUMA-7 Trial Eligibility Criteria

Inclusion Criteria

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

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I have completed first-line therapy with anti-CD20 and anthracycline for my condition.

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My lymphoma has not spread to my brain or spinal cord.

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My heart, lungs, liver, kidneys, and bone marrow are working well.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My diagnosis is large B-cell lymphoma.

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My cancer returned or didn't respond after my first chemoimmunotherapy.

ZUMA-7 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) Per Blinded Central Assessment

Secondary outcome measures

Change From Baseline in EORTC QLQ-C30 Physical Functioning Score

Change From Baseline in EQ-5D-5L VAS Scale Score

Change From Baseline in Global Health Status Scores

+11 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401

88%

Pyrexia

65%

Neutrophil count decreased

62%

Nausea

58%

Hypotension

50%

Anaemia

46%

Headache

38%

Decreased appetite

38%

Fatigue

35%

Confusional state

31%

Hypokalaemia

31%

Diarrhoea

31%

Tachycardia

27%

Constipation

27%

Back pain

27%

Hypophosphataemia

23%

Dizziness

23%

Platelet count decreased

23%

Tremor

23%

B-cell lymphoma

23%

White blood cell count decreased

19%

Oedema peripheral

19%

Neutropenia

19%

Cough

19%

Hypogammaglobulinaemia

19%

Hyponatraemia

19%

Tachypnoea

19%

Agitation

15%

Alanine aminotransferase increased

15%

Thrombocytopenia

15%

Chills

15%

Dyspnoea

15%

Hypomagnesaemia

15%

Sinus tachycardia

15%

Dysphagia

12%

Hypertension

12%

Vomiting

12%

Abdominal pain

12%

Aspartate aminotransferase increased

12%

Pain

12%

Malaise

12%

Myalgia

12%

Hypoxia

12%

Arthralgia

12%

Hyperglycaemia

12%

Covid-19

12%

Peripheral sensory neuropathy

Hyperhidrosis

Aphasia

Pancytopenia

Muscular weakness

Pneumonia

Encephalopathy

Eye pain

Gait disturbance

Oral candidiasis

Urinary tract infection

Sepsis

Blood creatinine increased

Acute myeloid leukaemia

Insomnia

Somnolence

Dysuria

Asthenia

Lymphocyte count decreased

Pleural effusion

Covid-19 pneumonia

Respiratory failure

Febrile neutropenia

Embolism

Depression

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

ZUMA-7 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Axicabtagene Ciloleucel TreatmentExperimental Treatment3 Interventions

Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning 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 antigen (CD) 19 CAR transduced autologous T cells/kg on Day 0.

Group II: Standard of Care TherapyActive Control1 Intervention

Participants will receive 2 or 3 21-day cycles of second-line chemotherapy regimen; R-ICE: rituximab 375 mg/m^2 before chemotherapy,ifosfamide 5 g/m^2 24hour(hr) infusion on Day 2+mesna,carboplatin area under the curve (AUC) 5 on Day 2, maximum dose 800 mg,etoposide 100 mg/ m^2/day on Days 1-3; R-ESHAP: rituximab 375 mg/m^2 Day 1,etoposide 40 mg/m^2/day IV on Days 1-4,methylprednisolone 500 mg/day IV on Days 1-4 or 5,cisplatin at 25 mg/m^2/day Days 1-4,cytarabine 2 g/m^2 on Day 5; R-GDP: rituximab 375 mg/m^2 Day 1(or Day 8),gemcitabine 1g/m^2 on Days 1 and 8,dexamethasone 40 mg on Days 1-4,cisplatin 75mg/m^2 on Day 1 or carboplatin AUC=5; or R-DHAP: Rituximab 375 mg/ m^2 before chemotherapy,dexamethasone 40 mg/day on Days 1-4,highdose cytarabine 2 g/m^2 every 12 hours for 2 doses on Day 2 following/platinum,cisplatin 100 mg/m^2 24hr infusion on Day 1 or oxaliplatin 100 mg/m^2. Participants who will respond will get high dose therapy and autologous stem cell transplant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axicabtagene Ciloleucel

2015

Completed Phase 2

~500

Cyclophosphamide

1995

Completed Phase 3

~3780

Fludarabine

2012

Completed Phase 3

~1100

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor

43 Previous Clinical Trials

3,297 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

28 Previous Clinical Trials

2,655 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03391466 — Phase 3

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

B-Cell Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT03391466 — Phase 3

Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03391466 — Phase 3

Frequently Asked Questions

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

How is Axicabtagene Ciloleucel most often employed?

"Axicabtagene Ciloleucel is a standard treatment for lung cancers. However, it has also been used to help patients with other conditions like multiple sclerosis, leukemia, myelocytic, acute, retinoblastoma."

Answered by AI

Are there any vacancies in this clinical trial for new patients?

"The clinicaltrials.gov website suggests that this study has completed recruitment for participants. However, there are nearly 3000 other trials recruiting patients right now."

Answered by AI

Is there a significant threat to people's health when taking Axicabtagene Ciloleucel?

"There is some evidence from previous clinical trials to support the efficacy of Axicabtagene Ciloleucel, which gives it a safety rating of 3."

Answered by AI

Is this the first time Axicabtagene Ciloleucel has been trialled?

"The first study evaluating axicabtagene ciloleucel was done in 1997 at City of Hope Comprehensive Cancer Center. A total of 1349 studies have been completed to date, with 1085 currently active studies. Many of these ongoing studies are based in Columbus, Ohio."

Answered by AI

How many people are included in this test group?

"The clinical trial you are inquiring about is now closed to new participants. The study was first posted on January 25th, 2018 and ended recruitment on October 26th, 2022. However, there are 1806 trials currently enrolling patients with relapsed/refractory diffuse large b-cell lymphoma (dlbcl) and 1085 trials for Axicabtagene Ciloleucel actively enrolling patients."

Answered by AI

In how many different places is this trial being run today?

"39 patients have already been recruited for this trial, with the James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center in Columbus, UPMC Hillman Cancer Center in Pittsburgh, and Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont in Montréal being some of the locations. There are also 39 other sites taking part in this study."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-hodgkin Lymphoma: The Lugano Classification

Cheson, Bruce D., Richard I. Fisher, Sally F. Barrington, Franco Cavalli, Lawrence H. Schwartz, Emanuele Zucca, and T. Andrew Lister. 2014. “Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-hodgkin Lymphoma: The Lugano Classification”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2013.54.8800.

Clinical Lymphoma Myeloma and LeukemiaJournal

Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/refractory Diffuse Large B-cell Lymphoma Undergoing Autologous Stem Cell Transplantation

Kambhampati, Swetha, Bradley Hunter, Andrei Varnavski, Bita Fakhri, Lawrence Kaplan, Weiyun Z. Ai, Miguel Pampaloni, et al.. 2021. “Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/refractory Diffuse Large B-cell Lymphoma Undergoing Autologous Stem Cell Transplantation”. Clinical Lymphoma Myeloma and Leukemia. Elsevier BV. doi:10.1016/j.clml.2020.11.005.

BloodJournal

The 2016 Revision of the World Health Organization Classification of Lymphoid Neoplasms

Swerdlow, Steven H., Elias Campo, Stefano A. Pileri, Nancy Lee Harris, Harald Stein, Reiner Siebert, Ranjana Advani, et al.. 2016. “The 2016 Revision of the World Health Organization Classification of Lymphoid Neoplasms”. Blood. American Society of Hematology. doi:10.1182/blood-2016-01-643569.

New England Journal of MedicineJournal