Trial Title:
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
NCT ID:
NCT05605899
Condition:
High-risk Large B-cell Lymphoma (LBCL)
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Fludarabine
Etoposide
Vincristine
Axicabtagene ciloleucel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Axicabtagene Ciloleucel
Description:
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Arm group label:
Axicabtagene Ciloleucel
Other name:
Yescarta®
Other name:
Axi-cel
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Administered intravenously
Arm group label:
Axicabtagene Ciloleucel
Arm group label:
Standard of Care Therapy
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Administered intravenously
Arm group label:
Axicabtagene Ciloleucel
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Administered intravenously
Arm group label:
Standard of Care Therapy
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Administered intravenously
Arm group label:
Standard of Care Therapy
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Administered intravenously
Arm group label:
Standard of Care Therapy
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Administered intravenously
Arm group label:
Standard of Care Therapy
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Administered orally
Arm group label:
Standard of Care Therapy
Summary:
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel,
versus standard of care (SOC) in first-line therapy in participants with high-risk large
B-cell lymphoma.
Detailed description:
Five years after randomization, participants who have received axicabtagene ciloleucel
will transition to a separate long-term follow-up study (study KT-US-982-5968) to
complete the remainder of the 15-year follow-up assessments.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health
Organization (WHO) classification by local pathology lab assessment, including of
the following:
- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
- High-grade B-cell lymphoma (HGBL)
- Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is
eligible if no prior treatment with anthracycline-containing regimen.
- High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5
at initial diagnosis.
- Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).
- Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
- Females of childbearing potential must have a negative serum or urine pregnancy
test.
Key Exclusion Criteria:
- The following WHO 2016 subcategories by local assessment:
- T-cell/histiocyte-rich LBCL
- Primary DLBCL of the central nervous system (CNS)
- Primary mediastinal (thymic) LBCL
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and
classical Hodgkin lymphoma
- Burkitt lymphoma
- History of Richter's transformation of chronic lymphocytic leukemia
- Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases,
or a history of CNS involvement of lymphoma.
- Presence of cardiac lymphoma involvement.
- Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.
- History of severe immediate hypersensitivity reaction to any of the agents used in
this study.
- Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior
reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment.
- History of acute or chronic active hepatitis B or C infection.
- Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV
medications, with an undetectable viral load by PCR and with a cluster of
differentiation 4 (CD4) count > 200 cells/uL.
- Medical conditions or residual toxicities from prior therapies likely to interfere
with assessment of safety or efficacy of study treatment. Please refer to protocol
for further details.
- History of clinically significant cardiac disease within 12 months before
enrollment.
- History of any medical condition requiring maintenance systemic
immunosuppression/systemic disease modifying agents within the last 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama Hospital
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Facility:
Name:
UC San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Los Angeles (UCLA)
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Cancer Institute
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgia Cancer Center at Augusta University
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Kansas Hospital
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute, St. Matthews Campus
Address:
City:
Shelbyville
Zip:
40065
Country:
United States
Status:
Recruiting
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Facility:
Name:
University of MD Greenebaum Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Cancer Center Outpatient Pharmacy
Address:
City:
Rochester
Zip:
55902
Country:
United States
Status:
Recruiting
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Facility:
Name:
Weill Cornell Medical College - NewYork Presbyterian Hospital
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Rochester Medical Center
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Facility:
Name:
Novant Health Cancer Institute- Hematology
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
Prisma Health Cancer Institute
Address:
City:
Greenville
Zip:
29615
Country:
United States
Status:
Recruiting
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Withdrawn
Facility:
Name:
Tennessee Oncology, PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry-Joyce Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas, MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program
Address:
City:
Salt Lake City
Zip:
84143
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Withdrawn
Facility:
Name:
Royal Prince Alfred Hospital
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Royal Brisbane and Women's Hospital
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Center
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Medizinische Universität Innsbruck
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Universitätsklinikum St. Pölten
Address:
City:
St. Poelten
Zip:
3100
Country:
Austria
Status:
Recruiting
Facility:
Name:
Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna)
Address:
City:
Vienna
Zip:
01090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Ottowa Hospital- General Campus
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Active, not recruiting
Facility:
Name:
CHU Bordeaux-Hopital Haut-Leveque
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Cedex Lyon 08
Zip:
69008
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Dijon
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Claude Huriez CHU Lille, Service Maladies du sang
Address:
City:
Lille cedex
Zip:
59037
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Eloi
Address:
City:
Montpellier CEDEX 05
Zip:
34295
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Nice
Address:
City:
Nice
Zip:
CS 23079
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Henri MONDOR, APHP
Address:
City:
Paris
Zip:
94000
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Pontchaillou
Address:
City:
Rennes CEDEX
Zip:
35033
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire(CHU) de Toulouse
Address:
City:
Toulouse
Zip:
31100
Country:
France
Status:
Recruiting
Facility:
Name:
Helios Klinikum Berlin-Buch
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Facility:
Name:
Charite Universitaetsmedizin Berlin
Address:
City:
Berlin
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum bonn, medizinische klinik III
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Status:
Recruiting
Facility:
Name:
Uniklinikum Duesseldorf, Klinik fuer Haematologie, Onkologie und klinische Immunologie
Address:
City:
Duesseldorf
Zip:
40225
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinik Erlangen
Address:
City:
Erlangen
Country:
Germany
Status:
Recruiting
Facility:
Name:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST Degli Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Address:
City:
Reggio Calabria
Zip:
89133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Universita Cattolica del Sacro Cuore
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Istituto Clinico Humanitas
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Facility:
Name:
University Hospital, Kyoto Prefectural University of Medicine
Address:
City:
Kyoto
Zip:
602-8566,
Country:
Japan
Status:
Recruiting
Facility:
Name:
Juntendo University Hospital
Address:
City:
Tokyo
Zip:
113-8431
Country:
Japan
Status:
Recruiting
Facility:
Name:
Academisch Medisch Centrum
Address:
City:
Amsterdam
Zip:
1081HV
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9700 RB
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Maastricht Universitair Medisch Centrum
Address:
City:
Maastricht
Zip:
62002
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Universitair Medisch Centrum Utrecht
Address:
City:
Utrecht
Zip:
3508 GA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria
Address:
City:
Lisbon
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - E.P.E.
Address:
City:
Lisbon
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Institut Catala d'Oncologia
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall D'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marqués de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Addenbrookes Hospital (Cambridge University Hospitals NHS Foundation Trust)
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University Hospitals Southampton
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Status:
Recruiting
Start date:
February 10, 2023
Completion date:
March 2031
Lead sponsor:
Agency:
Kite, A Gilead Company
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05605899
http://www.gileadclinicaltrials.com/study/?id=KT-US-484-0136
