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 : August 12, 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 (EFS) [ 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 (OS) [ Time Frame: Up to 5 years ]Overall survival is defined as the time from randomization to death from any cause
- Modified Event Free Survival (mEFS) [ Time Frame: Up to 5 years ]Event free survival is defined the same way as EFS, except that failure to attain CR or PR by Day 150 assessment is not considered an event. mEFS will be analyzed per blinded central review and per investigator disease assessments.
- Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]Progression Free Survival is defined as the time from randomization to disease progression per Lugano Classification (Cheson et al, 2014) or death from any cause
- Duration of Response (DOR) [ Time Frame: Up to 5 years ]Duration of Response is derived only among subjects who experience an objective response per Lugano Classification (Cheson et al, 2014) as determined by blinded central review and is defined as the time from first response to disease progression per the Lugano Classification or death from any cause
- Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel. [ Time Frame: Up to 5 years ]
- Changes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) domains [ Time Frame: Up to 5 years ]The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom 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.
- Changes over time in the European Quality of Life Five Dimensions Five Levels scale(EQ-5D-5L) [ Time Frame: Up to 5 years ]The Euro-QOL, Five Dimensions, Five Levels (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).
- Changes over time in the Visual analog scale (VAS) scores [ Time Frame: Up to 5 years ]The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the subjects' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each subject for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine").
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)||email@example.com|
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|Study Director:||Kite Study Director||Kite, A Gilead Company|