A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
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|ClinicalTrials.gov Identifier: NCT02601313|
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Mantle Cell Lymphoma||Biological: KTE-X19 Drug: Cyclophosphamide Drug: Fludarabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||March 2034|
Experimental: Single Arm. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion CAR transduced autologous T cells administered intravenously.
- Overall Response Rate [ Time Frame: Up to 24 months ]Objective response rate (ORR) is defined as the incidence of a CR or a PR per the Lugano Classification (Cheson et al, 2014), as determined by the Independent Radiology Review Committee (IRRC).
- Duration of Response [ Time Frame: Up to 24 months ]Duration of response (DOR) is defined as the time from their first objective response to disease progression or death.
- Best Objective Response [ Time Frame: Up to 24 months ]Best objective response is defined as the incidence of CR, PR, SD, progressive disease, or unevaluable as best response to treatment
- Progression Free Survival [ Time Frame: Up to 24 months ]Progression free survival (PFS) is defined as the time from the anti‑CD19 CAR T cells infusion date to the date of disease progression or death from any cause
- Objective Response Rate [ Time Frame: Up to 24 months ]Objective response rate (ORR) is defined as the incidence of either a CR or PR determined by investigator
- Overall Surival [ Time Frame: Up to 15 years ]Percentage of participants experiencing treatment-emergent adverse events; Percentage of participants who had clinically significant changes in laboratory values.
- Incidence of adverse events (AEs) and clinically significant changes in laboratory values [ Time Frame: Up to 15 years ]Percentage of Participants Experiencing Treatment-Emergent Adverse Events; Percentage of participants who had clinically significant changes in laboratory values.
- Incidence of anti-CD19 CAR antibodies [ Time Frame: Up to 15 years ]
- Levels of anti-CD19 CAR T cells in blood [ Time Frame: Up to 15 years ]
- Levels of cytokines in serum [ Time Frame: Up to 15 years ]
- Changes over time in the EQ-5D scale score and visual analogue scale score [ Time Frame: Up to 6 months ]The EQ-5D consists of a 5-dimension descriptive system, including questions on mobility, self-care, usual activities, pain/comfort, and anxiety/depression, and a visual analogue scale (VAS) that allows the respondent to record health on a vertical scale (eg, best health to worst health), thus allowing a quantitative measure of health outcome.
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): NCT02601313
|Contact: Medical Information||844-454-KITEemail@example.com|
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|Study Director:||Kite Study Director||Kite, A Gilead Company|