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CAR T-cell Therapy

Axicabtagene Ciloleucel for Follicular Lymphoma (ZUMA-1 Trial)

Phase 1 & 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 day 0 (pre-infusion) to data cutoff 27 jan 2017 (phase 1,cohorts 1,2), 26 apr 2018, 6 may 2019, 10 sep 2020, 16 jun 2020 for cohorts 3,4,5,6 respectively (maximum:20 months for phase 1,cohorts 1,2; 35, 47.5, 64, 61 months for cohorts 3,4,5,6 respectively)

Awards & highlights

ZUMA-1 Trial Summary

This trial will be conducted in three phases in order to study the safety and efficacy of the treatment axicabtagene ciloleucel.

Eligible Conditions

Follicular Lymphoma
B-Cell Lymphoma
Large B-Cell Lymphoma

ZUMA-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first or to data cutoff date of 27 jan 2017, 26 apr 2018, 6 may 2019, 10 sep 2010, and 16 jun 2020 for cohorts 1 and 2, 3, 4, 5, and 6 respectively (median duration: 5.3, 4.9, 11.1, 5.2, 11.4, and 5.8 months for cohorts 1, 2, 3, 4, 5, and 6 respectively)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first or to data cutoff date of 27 jan 2017, 26 apr 2018, 6 may 2019, 10 sep 2010, and 16 jun 2020 for cohorts 1 and 2, 3, 4, 5, and 6 respectively (median duration: 5.3, 4.9, 11.1, 5.2, 11.4, and 5.8 months for cohorts 1, 2, 3, 4, 5, and 6 respectively)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first or to data cutoff date of 27 jan 2017, 26 apr 2018, 6 may 2019, 10 sep 2010, and 16 jun 2020 for cohorts 1 and 2, 3, 4, 5, and 6 respectively (median duration: 5.3, 4.9, 11.1, 5.2, 11.4, and 5.8 months for cohorts 1, 2, 3, 4, 5, and 6 respectively) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)

Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma

Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades

+3 more

Secondary outcome measures

Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 4 and Grade 3 or Higher Resulting From Decreased Parameter Value

Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 4 and Grade 3 or Higher Resulting From Increased Parameter Value

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

+20 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-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: Axicabtagene CiloleucelExperimental Treatment3 Interventions

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, axicabtagene ciloleucel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axicabtagene Ciloleucel

2015

Completed Phase 2

~490

Fludarabine

2012

Completed Phase 3

~1100

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

3,349 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

28 Previous Clinical Trials

2,707 Total Patients Enrolled

Frequently Asked Questions

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

Are there different research centers in charge of this study?

"The full list of centres currently running this study are as follows: Washington University School of Medicine in Saint Louis, Banner MD Anderson Cancer Center in Gilbert, Stanford University in Palo Alto, and 25 other locations."

Answered by AI

How many people have agreed to take part in this research project?

"Unfortunately, this particular clinical trial is no longer recruiting. It was initially posted on April 21st, 2015 and last updated on October 17th, 2022. However, there are 1837 trials actively seeking candidates for high grade b-cell lymphoma (hgbcl) and 933 studies for Axicabtagene Ciloleucel that are currently looking for participants."

Answered by AI

Are there still positions available in this trial for test subjects?

"This particular trial is no longer recruiting patients. However, if you are seeking other studies, there are 1837 clinical trials actively recruiting participants with high grade b-cell lymphoma (hgbcl) and 933 trials for Axicabtagene Ciloleucel that still need participants."

Answered by AI

How is Axicabtagene Ciloleucel most often employed by doctors?

"Axicabtagene Ciloleucel is an approved treatment for patients with lung cancer, multiple sclerosis, and acute myelocytic leukemia."

Answered by AI

Are there similar treatments to Axicabtagene Ciloleucel that have been trialed before?

"City of Hope Comprehensive Cancer Center first researched axicabtagene ciloleucel in 1997 and, to date, 1274 trials have been completed. 933 more are underway with a large portion taking place in Saint Louis, Missouri."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Axicabtagene Ciloleucel CAR T-cell Therapy in Refractory Large B-cell Lymphoma

Neelapu, Sattva S., Frederick L. Locke, Nancy L. Bartlett, Lazaros J. Lekakis, David B. Miklos, Caron A. Jacobson, Ira Braunschweig, et al.. 2017. “Axicabtagene Ciloleucel CAR T-cell Therapy in Refractory Large B-cell Lymphoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1707447.

The Lancet OncologyJournal

Long-term Safety and Activity of Axicabtagene Ciloleucel in Refractory Large B-cell Lymphoma (ZUMA-1): A Single-arm, Multicentre, Phase 1–2 Trial

Locke, Frederick L, Armin Ghobadi, Caron A Jacobson, David B Miklos, Lazaros J Lekakis, Olalekan O Oluwole, Yi Lin, et al.. 2019. “Long-term Safety and Activity of Axicabtagene Ciloleucel in Refractory Large B-cell Lymphoma (ZUMA-1): A Single-arm, Multicentre, Phase 1–2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30864-7.

Blood AdvancesJournal

Tumor Burden, Inflammation, and Product Attributes Determine Outcomes of Axicabtagene Ciloleucel in Large B-cell Lymphoma

Locke, Frederick L., John M. Rossi, Sattva S. Neelapu, Caron A. Jacobson, David B. Miklos, Armin Ghobadi, Olalekan O. Oluwole, et al.. 2020. “Tumor Burden, Inflammation, and Product Attributes Determine Outcomes of Axicabtagene Ciloleucel in Large B-cell Lymphoma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020002394.

Journal of Hematology & OncologyJournal