NCT02348216

Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory 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)

Interventions

Type	Name	Description
BIOLOGICAL	Axicabtagene Ciloleucel	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.
DRUG	Fludarabine	Administered according to package insert
DRUG	Cyclophosphamide	Administered according to package insert
DRUG	Levetiracetam	Administered according to package insert
DRUG	Tocilizumab	Administered according to package insert
DRUG	Dexamethasone	Administered according to package insert
DRUG	High-dose methylprednisolone	Administered according to package insert
DRUG	Bendamustine	Administered according to package insert
DRUG	Rituximab	Administered according to package insert
DRUG	Doxorubicin	Administered according to package insert
DRUG	Prednisone	Administered according to package insert
DRUG	Vincristine	Administered according to package insert
DRUG	Ifosfamide	Administered according to package insert
DRUG	Carboplatin	Administered according to package insert
DRUG	Etoposide	Administered according to package insert
DRUG	Gemcitabine	Administered according to package insert
DRUG	Oxaliplatin	Administered according to package insert
DRUG	Cisplatin	Administered according to package insert
DRUG	Methylprednisolone	Administered according to package insert

Timeline

• Start date: 2015-04-21
• Primary completion: 2023-07-27
• Completion: 2023-07-27
• First posted: 2015-01-28
• Last updated: 2024-06-04
• Results posted: 2021-11-23

Locations

36 sites across 6 countries: United States, Canada, France, Germany, Israel, Netherlands

Regulatory

• FDA-regulated drug study