Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma (ZUMA-23)
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|ClinicalTrials.gov Identifier: NCT05605899|
Recruitment Status : Recruiting
First Posted : November 4, 2022
Last Update Posted : November 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|High-risk Large B-cell Lymphoma (LBCL)||Biological: Axicabtagene Ciloleucel Drug: Cyclophosphamide Drug: Fludarabine Drug: Etoposide Drug: Rituximab Drug: Doxorubicin Drug: Vincristine Drug: Prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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)|
|Actual Study Start Date :||February 10, 2023|
|Estimated Primary Completion Date :||March 2031|
|Estimated Study Completion Date :||March 2031|
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.
Biological: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Active Comparator: Standard of Care Therapy
Participants will receive the investigator's choice of one of the following therapies/dosing schedules:
- Event-free Survival (EFS) by Central Assessment [ Time Frame: Up to 5 years ]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.
- Progression-free Survival (PFS) by Investigator Assessment [ Time Frame: Up to 5 years ]PFS is defined as the time from randomization to disease progression or death due to any cause.
- Overall Survival [ Time Frame: Up to 5 years ]OS is defined as the time from randomization to death due to any cause.
- PFS by Central Assessment [ Time Frame: Up to 5 years ]PFS is defined as the time from randomization to disease progression or death due to any cause.
- Complete Response (CR) Rate by Central Assessment [ Time Frame: Up to 5 years ]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.
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths [ Time Frame: First dose date up to 5 years plus 30 days ]
- Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values [ Time Frame: First dose date up to 5 years plus 30 days ]
- Change From Baseline in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) Score [ Time Frame: Baseline, Month 18 ]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.
- 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 [ Time Frame: Baseline, Month 18 ]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.
- Change From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score [ Time Frame: Baseline, Month 18 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605899
|Contact: Medical Information||844-454-5483(1-844-454-KITE)||email@example.com|
|Study Director:||Kite Study Director||Kite, A Gilead Company|