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CAR T-cell Therapy
Axicabtagene Ciloleucel for 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
No Placebo-Only Group
Summary
This trial is testing axicabtagene ciloleucel, a treatment that modifies a patient's immune cells to fight cancer, in patients with high-risk large B-cell lymphoma. The goal is to see how well this treatment works.
Eligible Conditions
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
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)
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators
Secondary study objectives
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 moreSide effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Fatigue
38%
Decreased appetite
35%
Confusional state
31%
Tachycardia
31%
Diarrhoea
31%
Hypokalaemia
27%
Constipation
27%
Hypophosphataemia
27%
Back pain
23%
Dizziness
23%
Tremor
23%
B-cell lymphoma
23%
Platelet count decreased
23%
White blood cell count decreased
19%
Cough
19%
Agitation
19%
Hyponatraemia
19%
Neutropenia
19%
Tachypnoea
19%
Hypogammaglobulinaemia
19%
Oedema peripheral
15%
Hypomagnesaemia
15%
Thrombocytopenia
15%
Dysphagia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
15%
Chills
15%
Dyspnoea
12%
Aspartate aminotransferase increased
12%
Pain
12%
Arthralgia
12%
Myalgia
12%
Hypertension
12%
Abdominal pain
12%
Hyperglycaemia
12%
Hypoxia
12%
Vomiting
12%
Peripheral sensory neuropathy
12%
Covid-19
12%
Malaise
8%
Dysuria
8%
Muscular weakness
8%
Blood creatinine increased
8%
Hyperhidrosis
8%
Insomnia
8%
Acute myeloid leukaemia
8%
Encephalopathy
8%
Sepsis
8%
Pancytopenia
8%
Eye pain
8%
Urinary tract infection
8%
Lymphocyte count decreased
8%
Asthenia
8%
Somnolence
8%
Oral candidiasis
8%
Pneumonia
8%
Gait disturbance
8%
Aphasia
4%
Pleural effusion
4%
Depression
4%
Embolism
4%
Syncope
4%
Respiratory failure
4%
Febrile neutropenia
4%
Covid-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2020
Completed Phase 2
~510
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
Find a Location
Who is running the clinical trial?
Kite, A Gilead CompanyLead Sponsor
44 Previous Clinical Trials
3,938 Total Patients Enrolled
28 Trials studying Lymphoma
2,326 Patients Enrolled for Lymphoma
Kite Study DirectorStudy DirectorKite, A Gilead Company
29 Previous Clinical Trials
3,321 Total Patients Enrolled
19 Trials studying Lymphoma
1,971 Patients Enrolled for Lymphoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have or had a condition that affects your brain or nervous system, like seizures, strokes, memory problems, or autoimmune diseases that affect the brain.You have had a previous stem cell transplant using your own cells or cells from someone else.You have received treatment in the past that targeted the CD19 protein.You have had a heart attack, heart surgery, or other serious heart problems within the past year.You do not have any signs, concerns, or past experiences of lymphoma affecting your central nervous system (brain and spinal cord).You have received treatment with special types of therapy that modify your T-cells, such as CAR-T therapy or genetically modified T-cell therapy, in the past.You have experienced a blood clot in your leg or lungs within the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Axicabtagene Ciloleucel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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