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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05605899
Registration number
NCT05605899
Ethics application status
Date submitted
31/10/2022
Date registered
4/11/2022
Titles & IDs
Public title
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
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Scientific title
An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23)
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Secondary ID [1]
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2022-501489-24-00
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Secondary ID [2]
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KT-US-484-0136
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Universal Trial Number (UTN)
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Trial acronym
ZUMA-23
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
High-risk Large B-cell Lymphoma (LBCL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Axicabtagene Ciloleucel
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Treatment: Drugs - Etoposide
Treatment: Drugs - Rituximab
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone
Experimental: Axicabtagene Ciloleucel - Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepletion 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.
Active comparator: Standard of Care Therapy - Participants will receive the investigator's choice of one of the following therapies/dosing schedules:
* Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for a total of 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
* Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) for a total of 6 cycles (21-day cycle)
* Rituximab 375 mg/m\^2 on Day 1
* Etoposide 50 mg/m\^2 on Days 1 to 4
* Doxorubicin 10 mg/m\^2 on Days 1 to 4
* Vincristine 0.4 mg/m\^2 on Days 1 to 4
* Cyclophosphamide 750 mg/m\^2 on Day 5
* Prednisone 60 mg/m\^2 twice daily on Days 1 to 5
Treatment: Other: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Treatment: Drugs: Cyclophosphamide
Administered intravenously
Treatment: Drugs: Fludarabine
Administered intravenously
Treatment: Drugs: Etoposide
Administered intravenously
Treatment: Drugs: Rituximab
Administered intravenously
Treatment: Drugs: Doxorubicin
Administered intravenously
Treatment: Drugs: Vincristine
Administered intravenously
Treatment: Drugs: Prednisone
Administered orally
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival (EFS) by Blinded Central Assessment
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Assessment method [1]
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EFS, is defined as the time from randomization to the earliest occurrence of death due to any cause, disease progression/relapse, initiation of any non-protocol specified subsequent new lymphoma therapy for the treatment of residual disease or Biopsy-proven residual disease at the Month 6 disease assessment or later, regardless of whether subsequent new lymphoma therapy is initiated or not.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Progression-free Survival (PFS) by Blinded Central Assessment
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Assessment method [1]
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PFS is defined as the time from randomization to disease progression or death due to any cause.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Overall Survival
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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PFS by Investigator Assessment
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Assessment method [3]
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PFS is defined as the time from randomization to disease progression or death due to any cause.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Complete Response (CR) Rate by Blinded Central Assessment
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Assessment method [4]
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CR rate is defined as the proportion of participants who have achieved CR per Lugano classification after treatment completion and prior to subsequent new off protocol anti-lymphoma therapy.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
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Assessment method [5]
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Timepoint [5]
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First dose date up to 5 years plus 30 days
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Secondary outcome [6]
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Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
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Assessment method [6]
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Timepoint [6]
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First dose date up to 5 years plus 30 days
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Secondary outcome [7]
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Change From Baseline in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) Score
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Assessment method [7]
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The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) symptom single-item scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL). Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
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Timepoint [7]
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Baseline, Month 18
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Secondary outcome [8]
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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Hodgkin Lymphoma High Grade Module (EORTC QLQ-NHL-HG29) Score
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Assessment method [8]
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The EORTC QLQ-NHL-HG29 is a 29-item patient-reported assessment measuring patients' high-grade NHL-specific symptoms and functioning. The 29 items assess symptom burden due to disease and/or treatment, fatigue/physical condition, neuropathy, emotional impacts, and worries/fears health and functioning. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
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Timepoint [8]
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Baseline, Month 18
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Secondary outcome [9]
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Change From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score
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Assessment method [9]
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The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
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Timepoint [9]
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Baseline, Month 18
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Eligibility
Key inclusion criteria
Key
* Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health Organization (WHO) classification by local pathology lab assessment, including of the following:
* Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
* High-grade B-cell lymphoma (HGBL)
* Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen.
* High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis.
* Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).
* Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
* Females of childbearing potential must have a negative serum or urine pregnancy test.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* The following WHO 2016 subcategories by local assessment:
* T-cell/histiocyte-rich LBCL
* Primary DLBCL of the central nervous system (CNS)
* Primary mediastinal (thymic) LBCL
* B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
* Burkitt lymphoma
* History of Richter's transformation of chronic lymphocytic leukemia
* Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
* Presence of cardiac lymphoma involvement.
* Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.
* History of severe immediate hypersensitivity reaction to any of the agents used in this study.
* Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment.
* History of acute or chronic active hepatitis B or C infection.
* Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a cluster of differentiation 4 (CD4) count > 200 cells/uL.
* Medical conditions or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details.
* History of clinically significant cardiac disease within 12 months before enrollment.
* History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2031
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - South Brisbane
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Recruitment hospital [3]
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Peter MacCallum Cancer Center - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Kite, A Gilead Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
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Trial website
https://clinicaltrials.gov/study/NCT05605899
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Kite Study Director
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Kite, A Gilead Company
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Contact person for public queries
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Medical Information
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Phone
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844-454-5483(1-844-454-KITE)
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05605899