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CAR T-cell Therapy

Axicabtagene Ciloleucel for Follicular Lymphoma (ZUMA-22 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
Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
Must not have
Neuropathy greater than grade 2
Females who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is comparing a new treatment to the current standard of care for people with a certain type of lymphoma that has come back or doesn't respond to treatment. They will be looking at how well the new treatment works compared to the current standard by measuring how long people live without the disease getting worse.

Who is the study for?
This trial is for adults with a confirmed diagnosis of follicular lymphoma who need treatment and have at least one measurable lesion. They must have had the disease return or not respond after initial therapy, including those whose disease came back within 24 months or after two treatments. Pregnant women, individuals with certain nervous system disorders, severe neuropathy, active infections (including HIV and hepatitis), autoimmune diseases, cardiac issues in the past six months, prior CD19-targeted therapies or CAR T-cell therapies cannot participate.Check my eligibility
What is being tested?
The study is testing axicabtagene ciloleucel against standard care drugs like Vincristine, Prednisone, Bendamustine etc., to see which works better for relapsed/refractory follicular lymphoma. Participants will be randomly assigned to receive either the study drug or one of the standard care options.See study design
What are the potential side effects?
Axicabtagene ciloleucel may cause immune system reactions that can affect different body parts leading to symptoms like fever and fatigue; it might also lead to low blood cell counts increasing infection risk. Standard care drugs can cause hair loss, nausea/vomiting, weakness and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer returned or didn't respond after initial treatment and it's considered high-risk.
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My lymphoma is confirmed as follicular and is either grade 1, 2, or 3a.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe nerve pain or numbness.
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I am not pregnant or breastfeeding.
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My condition is Follicular Lymphoma Grade 3b.
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I do not have an active infection with HIV, hepatitis B, or hepatitis C.
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I have previously received treatment targeting CD19.
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My lymphoma affects my heart.
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I have a significant brain or nerve condition.
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I have large B cell lymphoma or transformed follicular lymphoma.
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I do not have any untreated infections.
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I am not willing to use birth control.
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I have not had CAR T-cell therapy or any genetically modified T-cell treatment.
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My lymphoma has spread through the entire thickness of my stomach wall.
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I have a medical tube or drain in my body, but ports like Port-a-Cath are okay.
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I have a history of CNS lymphoma.

Timeline

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
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
Secondary outcome measures
Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)
Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30
+13 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%
Diarrhoea
31%
Hypokalaemia
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Platelet count decreased
23%
Dizziness
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Hyponatraemia
19%
Hypogammaglobulinaemia
19%
Tachypnoea
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Agitation
15%
Chills
15%
Hypomagnesaemia
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Dyspnoea
15%
Sinus tachycardia
15%
Dysphagia
12%
Covid-19
12%
Aspartate aminotransferase increased
12%
Hyperglycaemia
12%
Abdominal pain
12%
Hypoxia
12%
Vomiting
12%
Malaise
12%
Hypertension
12%
Pain
12%
Myalgia
12%
Arthralgia
12%
Peripheral sensory neuropathy
8%
Gait disturbance
8%
Blood creatinine increased
8%
Lymphocyte count decreased
8%
Dysuria
8%
Pancytopenia
8%
Sepsis
8%
Hyperhidrosis
8%
Oral candidiasis
8%
Urinary tract infection
8%
Aphasia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Asthenia
4%
Embolism
4%
Respiratory failure
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Febrile neutropenia
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

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 lymphodepleting 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.
Group II: Standard of Care TherapyActive Control7 Interventions
Participants will receive the investigator's choice of one of the following therapies/dosing schedules: Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle) Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22 Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 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 Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) rituximab 375 mg/m^2 on Day 1 bendamustine 90 mg/m^2 on Day 1 and Day 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axicabtagene Ciloleucel
2020
Completed Phase 2
~510
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
44 Previous Clinical Trials
3,846 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
29 Previous Clinical Trials
3,204 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05371093 — Phase 3
Follicular Lymphoma Research Study Groups: Standard of Care Therapy, Axicabtagene Ciloleucel
Follicular Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT05371093 — Phase 3
Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371093 — Phase 3
~153 spots leftby Oct 2030
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