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CAR T-cell Therapy

Axicabtagene Ciloleucel for Non-Hodgkin's Lymphoma (ZUMA-12 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 first infusion date of axicabtagene ciloleucel to data cut off date of 17 may 2021 (up to approximately 26.2 months)

Awards & highlights

ZUMA-12 Trial Summary

This trial is looking at the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma. Participants who received the infusion will be followed for 15 years to assess efficacy.

Eligible Conditions

Non-Hodgkin's Lymphoma

ZUMA-12 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first infusion date of axicabtagene ciloleucel to data cut off date of 17 may 2021 (maximum duration: 26.2 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first infusion date of axicabtagene ciloleucel to data cut off date of 17 may 2021 (maximum duration: 26.2 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first infusion date of axicabtagene ciloleucel to data cut off date of 17 may 2021 (maximum duration: 26.2 months) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators

Secondary outcome measures

Duration of Response (DOR) Per the Lugano Classification

Event-Free Survival (EFS)

Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators

+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-12 Trial Design

1Treatment groups

Experimental Treatment

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 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 (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered.

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

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

3,614 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

28 Previous Clinical Trials

2,972 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03761056 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: Axicabtagene Ciloleucel

Non-Hodgkin's Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT03761056 — Phase 2

Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03761056 — Phase 2

Frequently Asked Questions

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

Are participants still being sought for this research project?

"As of right now, this study is not looking for new patients. However, it was first posted on 1/29/2019 and edited as recently as 7/20/2022. If you are interested in other studies, there are 1789 lymphoma trials and 933 Axicabtagene Ciloleucel clinical trials recruiting patients."

Answered by AI

What other scientific studies have included Axicabtagene Ciloleucel?

"City of Hope Comprehensive Cancer Center first studied axicabtagene ciloleucel in 1997 and, to date, 1274 clinical trials have completed. As of right now, 933 different clinical trials are still active with many of them based in Ottawa, Texas."

Answered by AI

Could you please share the total number of individuals who have signed up for this clinical trial?

"This particular clinical trial is not enrolling new patients at this time. The study was first posted on 29 January 2019 and was last updated 20 July 2022. However, there are other ongoing trials that might be of interest; as of right now, there are 1789 lymphoma trials and 933 Axicabtagene Ciloleucel studies recruiting patients."

Answered by AI

How many total research facilities are coordinating this trial?

"There are 10 enrolling patients for this study at locations such as Ottawa Hospital in Ottawa, The University of Texas MD Anderson Cancer Center in Houston, and Vanderbilt University Medical Center in Nashville."

Answered by AI

Has the FDA given its okay to market and sell Axicabtagene Ciloleucel?

"There is some clinical data backing Axicabtagene Ciloleucel's safety, but no evidence yet of its efficacy. Therefore, it received a score of 2."

Answered by AI

For what purpose is Axicabtagene Ciloleucel commonly administered?

"Axicabtagene Ciloleucel is a medication that has been approved to treat certain lung cancers as well as conditions such as multiple sclerosis, leukemia, myelocytic, acute, and retinoblastoma."

Answered by AI

Recent research and studies

Nature MedicineJournal

Axicabtagene Ciloleucel as First-line Therapy in High-risk Large B-cell Lymphoma: The Phase 2 ZUMA-12 Trial

Neelapu, Sattva S., Michael Dickinson, Javier Munoz, Matthew L. Ulrickson, Catherine Thieblemont, Olalekan O. Oluwole, Alex F. Herrera, et al.. 2022. “Axicabtagene Ciloleucel as First-line Therapy in High-risk Large B-cell Lymphoma: The Phase 2 ZUMA-12 Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-022-01731-4.

Nature MedicineJournal

Axicabtagene Ciloleucel as First-line Therapy in High-risk Large B-cell Lymphoma: The Phase 2 ZUMA-12 Trial

clinicaltrials.govStudy

Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma

2019. "Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03761056.