NCT02348216View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

April 21, 2015

Primary Completion Date

July 27, 2023

Study Completion Date

July 27, 2023

Conditions
Refractory Diffuse Large B Cell Lymphoma (DLBCL)Relapsed Diffuse Large B-Cell LymphomaTransformed Follicular Lymphoma (TFL)Primary Mediastinal B-cell Lymphoma (PMBCL)High Grade B-cell Lymphoma (HGBCL)
Interventions
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

Trial Locations (36)

10467

Montefiore Medical Center, The Bronx

14642

University of Rochester, Rochester

33136

University of Miami, Miami

33612

Moffitt Cancer Center, Tampa

35033

CHU de Rennes, Rennes

37203

Sarah Cannon - Tennesee, Nashville

37232

Vanderbilt University, Nashville

44035

Hopital Haut-Leveque, Pessac

44195

Cleveland Clinic - Taussig Cancer Institute, Cleveland

45147

University Hospital of Essen, Essen

48201

Karmanos Cancer Center, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

55905

Mayo Clinic, Rochester

60153

Loyola University Medical Center, Maywood

63110

Washington University School of Medicine, St Louis

64239

Tel Aviv Souraski Medical Center, Tel Aviv

75475

Hopital Saint Louis, Paris

78229

Sarah Cannon-Methodist Healthcare System - San Antonio, San Antonio

80218

Sarah Cannon - Denver, Denver

85234

Banner MD Anderson Cancer Center, Gilbert

90404

University of California Los Angeles (UCLA), Santa Monica

94305

Stanford University, Palo Alto

97080

Universitaetsklinikum Wuerzburg, Würzburg

91010-3012

City of Hope, Duarte

92093-0820

University of California San Diego (UCSD), La Jolla

02215

Dana Farber Cancer Institute, Boston

68198-7680

University of Nebraska, Omaha

07601

Hackensack University Medical Center, Hackensack

77030-4000

MD Anderson Cancer Center, Houston

V5Z 1M9

Vancouver General Hospital, Vancouver

M5G 2M9

Princess Margaret, Toronto

01307

Universitätsklinik Dresden, Dresden

Unknown

Academisch Medisch Centrum, Amsterdam

9700 RB

University Medical Center Groningen, Groningen

3015 CE

Erasmus MC, Rotterdam

3584 CX

University Medical Center Utrecht, Utrecht

All Listed Sponsors
lead

Kite, A Gilead Company

INDUSTRY

NCT02348216 - Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma | Biotech Hunter | Biotech Hunter