Phase
Condition
Lymphoma
Follicular Lymphoma
Treatment
Prednisone
Bendamustine
Fludarabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-riskdisease with relapse or progression within 24 months of the initial course ofchemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines oftherapy
Clinical indication for treatment.
At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion
Key Exclusion Criteria:
Presence of large B cell lymphoma or transformed FL
Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma
Full-thickness involvement of the gastric wall by lymphoma
FL Grade 3b
Prior CD19-targeted therapy
Prior CAR therapy or other genetically modified T-cell therapy
Uncontrolled fungal, bacterial, viral, or other infection
Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis Cvirus
History or presence of a clincially significant central nervous system (CNS)disorder.
History of autoimmune disease
Known history or CNS lymphoma involvement
Cardiac lymphoma involvement
History of clinically significant cardiac disease 6 months before randomization
Neuropathy greater than grade 2
Females who are pregnant or breastfeeding
Individuals of both genders who are not willing to practice birth control
Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube,indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardialcatheter, or Ommaya reservoirs). Dedicated central venous access catheters such asPort-a-Cath or Hickman catheter are permitted.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Hopital Henri Mondor
Créteil, 94010
FranceSite Not Available
CHU de Dijon
Dijon, 21079
FranceSite Not Available
Hôpital Claude Huriez-CHU de Lille
Lille cedex, 59037
FranceSite Not Available
Institut Paoli-Calmettes
Marseille, 13273
FranceSite Not Available
Hopital Saint Eloi
Montpellier, 34295
FranceSite Not Available
Hopital Pitie-Salpetriere
Paris, 75013
FranceSite Not Available
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
Pessac, 33604
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre Benite, 69495
FranceSite Not Available
CHU de Poitiers
Poitiers, 86021
FranceSite Not Available
Hopital Pontchaillou - CHU Rennes
Rennes, 35033
FranceSite Not Available
Centre Henri Becquerel
Rouen, 76038
FranceSite Not Available
Helios Klinikum Berlin-Buch
Berlin, 13125
GermanySite Not Available
Universitatsklinikum Koln Klinik I fur Innere Medizin
Cologne, 50937
GermanySite Not Available
Universitatsmedizin Gottingen
Göttingen, 37075
GermanySite Not Available
Universitat Leipzig Herzzentrum GmbH
Leipzig, 4103
GermanySite Not Available
Universitatsklinikum Ulm
Ulm, 89081
GermanySite Not Available
Universitatsklinikum Koln Klinik I fur Innere Medizin
Wuerzburg, 97080
GermanySite Not Available
ASST Papa Giovanni XXIII
Bergamo, 24128
ItalySite Not Available
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, 40138
ItalySite Not Available
IRCCS Ospedale Policlinico San Martino Padiglione Ex-Isolamento/IST/Padiglione
Genova, 16132
ItalySite Not Available
Fondazione IRCCS - Istituto Nazionale Tumori
Milano, 20100
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
ItalySite Not Available
Istituto Clinico Humanitas-IRCCS
Rozzano, 20089
ItalySite Not Available
Hyogo Medical University Hospital
Hyogo, 663-8501
JapanSite Not Available
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566,
JapanSite Not Available
Tohoku University Hospital
Miyagi, 980-8574
JapanSite Not Available
Okayama University Hospital
Okayama, 700-8558
JapanSite Not Available
Osaka University Hospital
Osaka, 565-0871
JapanSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
SpainSite Not Available
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
Barcelona, 08908
SpainSite Not Available
Hospital 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28009
SpainSite Not Available
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Clínico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
University Hospital Birmingham NHS Foundation Trust
Birmingham, B15 2GW
United KingdomSite Not Available
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 2QQ
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust
London, NW2 2QG
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester, M20 4BX
United KingdomSite Not Available
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
United KingdomSite Not Available
The University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United KingdomSite Not Available
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
United KingdomSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California 91010
United StatesSite Not Available
UC Irvine Health
Orange, California 92868
United StatesSite Not Available
Stanford Health Care
Stanford, California 94305
United StatesSite Not Available
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesSite Not Available
Georgetown University Medical Center
Washington, District of Columbia 20007
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
The University of Kansas Hospital
Westwood, Kansas 66205
United StatesSite Not Available
University of Kentucky Medical Center
Lexington, Kentucky 40536
United StatesSite Not Available
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina 28204
United StatesSite Not Available
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45242
United StatesSite Not Available
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Prisma Health - Upstate
Greenville, South Carolina 29615
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
United StatesSite Not Available
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee 37203
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available
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