Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma (ZUMA-12)
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|ClinicalTrials.gov Identifier: NCT03761056|
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|B-cell Lymphoma||Biological: Axicabtagene Ciloleucel Drug: Fludarabine Drug: Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12)|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2036|
Experimental: Axicabtagene Ciloleucel
Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, axicabtagene ciloleucel
Biological: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
Other Name: Yescarta®
Administered according to package insert
Administered according to package insert
- Complete Response (CR) Rate [ Time Frame: Up to 2 years ]Complete Response rate is defined as the incidence of a CR per the Lugano Classification (Cheson et al, 2014), as determined by study investigators.
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.
- Duration of Response (DOR) [ Time Frame: Up to 2 years ]DOR is defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and is the time from the first objective response to disease progression or death from any cause.
- Event-Free Survival (EFS) [ Time Frame: Up to 5 years ]EFS is defined as the time from the axicabtagene ciloleucel infusion date to the earliest date of disease progression, commencement of subsequent new anti-lymphoma therapy including stem cell transplant (SCT), or death from any cause.
- Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression or death from any cause.
- Overall Survival (OS) [ Time Frame: Up to 5 years ]OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause.
- Percentage of participants experiencing adverse events and Clinical Significant Changes in Safety Lab Values [ Time Frame: Up to 2 years ]
- Relapse with Central Nervous Disease (CNS) Disease [ Time Frame: Up to 5 years ]Relapse with CNS disease is defined as the time from the axicabtagene ciloleucel infusion date to the earliest date of CNS involvement with lymphoma as determined by typical symptoms, CSF evaluation, and/or diagnostic imaging.
- Levels of anti-CD19 CAR T cells in blood [ Time Frame: Up to 1 year ]
- Levels of cytokines in serum [ Time Frame: Up to 1 year ]
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): NCT03761056
|Contact: Medical Information||1-844-454-5483(1-844-454-KITE)||firstname.lastname@example.org|
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|Study Director:||Kite Study Director||Kite, A Gilead Company|