At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 307 enrolled

Drug / intervention

Axicabtagene Ciloleucel +18 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02348216

NCT02348216Phase 2Completed

Compare CT.gov

A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

Kite, A Gilead Company·interventional·Posted Jan 28, 2015·Updated Jun 4, 2024

In Brief

A Phase 2 clinical trial evaluating Axicabtagene Ciloleucel, Fludarabine, and 17 other interventions for Refractory Diffuse Large B Cell Lymphoma (DLBCL) and 4 related conditions. Completed, enrolled 307 participants across 36 sites in 6 countries.

Detailed Summary

This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6). The primary objectives of this study are: * Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens * Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel * Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRefractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma (TFL), Primary Mediastinal B-cell Lymphoma (PMBCL), High Grade B-cell Lymphoma (HGBCL)

CountriesCanada, France, Germany, Israel, Netherlands, United States

Collaborators--

Timeline

Phase 2CompletedFinished

201520162017201820192020202120222023202420252026

First PostedJan 2015

Enrollment StartApr 2015

Primary CompletionJul 2023

TodayJul 2026

First PostedJan 28, 2015

Enrollment StartApr 21, 2015

Primary CompletionJul 27, 2023

TodayJul 2, 2026

Enrollment to primary: 8.3 yearsPosted 11.4 years ago

Interventions

Axicabtagene Ciloleucelbiological

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Fludarabinedrug