Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
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|ClinicalTrials.gov Identifier: NCT03391466|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)||Biological: Axicabtagene Ciloleucel Drug: Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders. Drug: Cyclophosphamide Drug: Fludarabine||Phase 3|
This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.
Standard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two arms, SOC and experimental treatment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma|
|Actual Study Start Date :||December 14, 2017|
|Estimated Primary Completion Date :||January 15, 2022|
|Estimated Study Completion Date :||January 15, 2035|
|Experimental: Axicabtagene Ciloleucel Treatment||
Biological: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide
|Active Comparator: Standard of Care Therapy||
Drug: Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.
Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.
- Event Free Survival [ Time Frame: Up to 5 years ]Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review
- Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review
- Overall Survival [ Time Frame: Up to 5 years ]Overall survival is defined as the time from randomization to death from any cause
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): NCT03391466
|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|