Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-4)
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|ClinicalTrials.gov Identifier: NCT02625480|
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Biological: KTE-C19 Drug: Fludarabine Drug: Cyclophosphamide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-4)|
|Actual Study Start Date :||February 1, 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||October 2034|
Experimental: Single Arm
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR+ T cells/kg or 1 x 10^6 anti-CD19 CAR+ T cells/kg
- Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]Dose-limiting toxicity is defined as protocol-defined KTE-C19-related events with onset within the first 28 days following KTE-C19 infusion.
- Phase 2: Overall Complete Remission Rate [ Time Frame: Up to 24 months ]Overall complete remission rate will be determined per independent review.
- Duration of Remission [ Time Frame: Up to 24 months ]Duration of remission is defined as the time between the participant's first complete response per independent review to relapse or any death in the absence of documented relapse.
- Minimum Residual Disease Negative Remission Rate [ Time Frame: Up to 3 months ]Minimal residual disease (MRD) response rate is defined as MRD < 10^-4 per the standard assessment.
- Allogeneic Stem Cell Transplant Rate [ Time Frame: Up to 24 months ]The incidence of allogeneic stem cell transplant will be analyzed.
- Overall Survival [ Time Frame: Up to 15 years ]Overall survival is defined as the time from KTE-C19 infusion to the date of death from any cause.
- Relapse-Free Survival [ Time Frame: Up to 24 months ]Relapse-Free Survival is defined as the time from the KTE-C19 infusion date to the date of disease relapse or death from any cause.
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to 15 years ]
- Percentage of Participants Experiencing Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values [ Time Frame: Up to 15 years ]
- Percentage of Participants with Anti-KTE-C19 Antibodies [ Time Frame: Up to 15 years ]
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): NCT02625480
|Contact: Medical Information||844-454-KITEfirstname.lastname@example.org|
Show 21 Study Locations
|Study Director:||Kite Study Director||Kite, A Gilead Company|