Phase
Condition
Lymphoproliferative Disorders
Allo-hematopoietic Stem Cell Transplant
Treatment
tabelecleucel
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combinationof these (C-SOT); or prior allogeneic HCT (C-HCT)
A diagnosis of locally assessed, biopsy-proven EBV+ PTLD
Availability of appropriate partially HLA-matched and restricted tabelecleucel hasbeen confirmed by the sponsor
Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease usingLugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandatedby local practice, then magnetic resonance imaging (MRI) may be used. For subjectswith treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRIas clinically appropriate will be required to follow CNS disease response per LuganoClassification response criteria.
Treatment failure of rituximab or interchangeable commercially available biosimilarmonotherapy (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentiallyadministered chemotherapy regimen (C-SOT-R+C) for treatment of PTLD.
Males and females of any age.
Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16years; Lansky score ≥ 20 for subjects < 16 years
For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoidor myeloid malignancy, the underlying primary disease for which the subjectunderwent transplant must be in morphologic remission
Adequate organ function
Absolute neutrophil count ≥ 1000/μL, (C-SOT) or ≥ 500/μL (C-HCT), with orwithout cytokine support
Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support.For C-HCT, platelet count < 50,000/μL but ≥ 20,000/μL, with or withouttransfusion support, is permissible if the subject has not had grade ≥ 2bleeding in the prior 4 weeks (where grading of the bleeding is determined perthe National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and totalbilirubin each < 5 × the upper limit of normal; however, ALT, AST, andtotal bilirubin each ≤ 10 × upper limit of normal is acceptable if theelevation is considered by the investigator to be due to EBV and/or PTLDinvolvement of the liver as long as there is no known evidence of significantliver dysfunction
Subject or subject's representative is willing and able to provide written informedconsent
Exclusion
Exclusion Criteria:
Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma
Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent,ongoing methotrexate, or extracorporeal photopheresis
Untreated CNS PTLD or CNS PTLD for which the subject is actively receivingCNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment.NOTE:Subjects with previously treated CNS PTLD may enroll if CNS-directed therapy iscomplete.
Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center forInternational Blood and Marrow Transplant Research consensus grading system atenrollment
Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab,pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose toenrollment
For C-HCT: active adenovirus viremia
Need for vasopressor or ventilatory support
Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior toenrollment
Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigenreceptor T cells directed against B cells within 8 weeks of enrollment (C-SOT orC-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCTonly)
Female who is breastfeeding or pregnant or female of childbearing potential or malewith a female partner of childbearing potential unwilling to use a highly effectivemethod of contraception
Inability to comply with study-related procedures
Any medical condition or organ system dysfunction that in the investigator'sopinion, could compromise the participant's safety or ability to completethe study
Study Design
Study Description
Connect with a study center
The Children's Hospital at Westmead (Pediatrics only)
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Westmead Hospital (Adults only)
Westmead, New South Wales 2145
AustraliaActive - Recruiting
The Prince Charles Hospital (Adults only)
Chermside, Queensland 4032
AustraliaActive - Recruiting
Royal Adelaide Hospital (Adults only)
Adelaide, South Australia 5000
AustraliaActive - Recruiting
The Royal Children's Hospital Melbourne (Pediatrics only)
Melbourne, Victoria 3052
AustraliaActive - Recruiting
Fiona Stanley Hospital (Adults only)
Murdoch, Western Australia 6150
AustraliaActive - Recruiting
Medizinische Universitat Wien (Adults only)
Wien, 1090
AustriaActive - Recruiting
Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)
Liège, Brussels 4000
BelgiumActive - Recruiting
Universitair Ziekenhuis Leuven (Adults and Pediatrics)
Leuven, Flemish Brabant 3000
BelgiumActive - Recruiting
Alberta Children's Hospital (Adults and Pediatrics)
Calgary, Alberta T3B 6A8
CanadaActive - Recruiting
Princess Margaret Cancer Centre (Adults only)
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Sick Kids (Pediatrics only)
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Centre Hospitalier Universitaire de Bordeaux (Adults only)
Pessac, Aquitaine 33600
FranceActive - Recruiting
Groupe Hospitalier du Haut Leveque (Adults only)
Pessac, Aquitaine 33600
FranceActive - Recruiting
Hôpital Saint Antoine (Adults only)
Paris, Ile-de-France 75571
FranceActive - Recruiting
Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)
Lille cedex, Nord-Pas-de-Calais 59037
FranceActive - Recruiting
Hôpital Necker-Enfants Malades (Pediatrics only)
Paris 15, Île-de-France 75015
FranceActive - Recruiting
Hôpital Universitaire Pitié Salpêtrière (Adults only)
Paris Cedex 13, Île-de-France 75651
FranceActive - Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)
Milano, 20162
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)
Pavia, 27100
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli (Adults only)
Roma, 00168
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesu (Pediatrics only)
Roma, 165
ItalyActive - Recruiting
Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)
Torino, 10126
ItalyActive - Recruiting
Hospital Duran i Reynals
Badalona, Barcelona 8908
SpainActive - Recruiting
Hospital Duran i Reynals (Adults and Pediatrics)
Badalona, Barcelona 8908
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)
Barcelona, 08035
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)
Madrid, 28009
SpainActive - Recruiting
University Hospital Virgen del Rocio (Adults and Pediatrics)
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario La Fe (Adults and Pediatrics)
Valencia, 46009
SpainActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust (Adults only)
Birmingham, England B15 2GW
United KingdomActive - Recruiting
Imperial College Healthcare NHS Trust (Adults only)
London, England W12 0HS
United KingdomActive - Recruiting
King's College Hospital NHS Foundation Trust (Adults only)
London, England SE5 9RS
United KingdomCompleted
City of Hope (Adults and Pediatrics)
Duarte, California 91010
United StatesCompleted
University of California San Diego Moores Cancer Center (Adults only)
La Jolla, California 92093
United StatesCompleted
Loma Linda University Cancer Center (Adults only)
Loma Linda, California 92354
United StatesActive - Recruiting
Loma Linda University Medical Center (Adults only)
Loma Linda, California 92354
United StatesSite Not Available
Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)
Los Angeles, California 90027
United StatesSite Not Available
UCLA Medical Center (Adults and Pediatrics)
Los Angeles, California 90095
United StatesCompleted
University of California Davis Comprehensive Cancer Center (Adults only)
Sacramento, California 95817
United StatesCompleted
Yale University (Adults and Pediatrics)
New Haven, Connecticut 06519
United StatesCompleted
MedStar Georgetown University Hospital (Adults and Pediatrics)
Washington, District of Columbia 20007
United StatesSite Not Available
University of Florida (Adults and Pediatrics)
Gainesville, Florida 32610
United StatesCompleted
University of Miami/Jackson Memorial Hospital (Adults only)
Miami, Florida 33136
United StatesSite Not Available
Arthur M. Blank Hospital (Pediatrics)
Atlanta, Georgia 30329
United StatesSite Not Available
Children's Healthcare of Atlanta at Egleston (Pediatrics)
Atlanta, Georgia 30322-1060
United StatesActive - Recruiting
Winship Cancer Institute (Adults only)
Atlanta, Georgia 30322
United StatesCompleted
Winship Cancer Institute of Emory University (Adults only)
Atlanta, Georgia 30322
United StatesActive - Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)
Chicago, Illinois 60611
United StatesSite Not Available
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)
Chicago, Illinois 60637
United StatesCompleted
Loyola University Medical Center (Adults and Pediatrics)
Maywood, Illinois 60153
United StatesSite Not Available
University of Maryland School of Medicine (Adults only)
Baltimore, Maryland 21201
United StatesCompleted
Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)
Boston, Massachusetts 02215
United StatesSite Not Available
Washington University School of Medicine (Adults only)
Saint Louis, Missouri 63110
United StatesSite Not Available
Montefiore Medical Center (Adults only)
Bronx, New York 10467
United StatesCompleted
Montefiore Medical Center (Pediatrics only)
Bronx, New York 10467
United StatesCompleted
Columbia University Medical Center (Adults and Pediatrics)
New York, New York 10032
United StatesCompleted
Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)
New York, New York 10065
United StatesSite Not Available
Weill Cornell Medicine (Adults only)
New York, New York 10021
United StatesCompleted
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)
Chapel Hill, North Carolina 27599
United StatesCompleted
Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)
Charlotte, North Carolina 28204
United StatesSite Not Available
Duke Cancer Institute (Adults only)
Durham, North Carolina 27710
United StatesSite Not Available
Cleveland Clinic Foundation (Adults and Pediatrics)
Cleveland, Ohio 44195
United StatesSite Not Available
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics)
Columbus, Ohio 43210
United StatesSite Not Available
Nationwide Children's Hospital (Pediatrics only)
Columbus, Ohio 43205
United StatesCompleted
The Ohio State University - Arthur G. James Cancer Center Hospital (Adults and Pediatrics)
Columbus, Ohio 43210
United StatesActive - Recruiting
Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)
Portland, Oregon 97239
United StatesSite Not Available
Children's Hospital of Philadelphia (Pediatrics only)
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Hospital of the University of Pennsylvania (Adults only)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania (Adults only)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Medical Center (Adults only)
Pittsburgh, Pennsylvania 15232
United StatesCompleted
Medical University of South Carolina (Adults and Pediatrics)
Charleston, South Carolina 29425
United StatesSite Not Available
Saint Jude Children's Research Hospital (Pediatrics only)
Memphis, Tennessee 38105
United StatesCompleted
Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)
Nashville, Tennessee 37232
United StatesSite Not Available
Baylor Scott and White Research Institute (Adults only)
Dallas, Texas 75246
United StatesSite Not Available
University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)
Dallas, Texas 75390
United StatesSite Not Available
MD Anderson Cancer Center (Adults and Pediatrics)
Houston, Texas 77030
United StatesActive - Recruiting
MD Anderson Cancer Center (Pediatrics and Adult)
Houston, Texas 77030
United StatesSite Not Available
Froedtert Hospital & the Medical College of Wisconsin (Adults only)
Milwaukee, Wisconsin 53226
United StatesCompleted
Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only)
Milwaukee, Wisconsin 53226
United StatesCompleted
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