Actively Recruiting
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Led by Pierre Fabre Medicament · Updated on 2026-02-20
115
Participants Needed
71
Research Sites
656 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.
CONDITIONS
Official Title
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior solid organ transplant (kidney, liver, heart, lung, pancreas, small bowel, or combination) or prior allogeneic hematopoietic cell transplant
- Diagnosis of biopsy-proven Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)
- Confirmed availability of partially HLA-matched and restricted tabelecleucel
- Measurable systemic disease with PET-CT or MRI according to Lugano Classification criteria
- Treatment failure of rituximab alone or rituximab plus chemotherapy for PTLD
- Males and females of any age
- Performance status of ≤3 for age ≥16 years or Lansky score ≥20 for age <16 years
- For allogeneic hematopoietic cell transplant recipients treated for acute lymphoid or myeloid malignancy, primary disease must be in remission
- Adequate organ function including specified blood counts and liver enzyme levels
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Active Burkitt, T-cell, NK/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, hemophagocytic lymphohistiocytosis, or other malignancies needing systemic therapy
- Daily steroids >0.5 mg/kg prednisone or equivalent, ongoing methotrexate, or extracorporeal photopheresis
- Untreated central nervous system (CNS) PTLD or actively treated CNS PTLD at enrollment
- Suspected or confirmed grade ≥2 graft-versus-host disease (GvHD) at enrollment
- Recent use of checkpoint inhibitors within 3 drug half-lives before enrollment
- Active adenovirus viremia for hematopoietic cell transplant recipients
- Need for vasopressor or ventilatory support
- Recent antithymocyte globulin or similar therapy within 4 weeks prior to enrollment
- Recent treatment with EBV cytotoxic T lymphocytes, CAR T cells for B cells, or donor lymphocyte infusion within 8 weeks
- Breastfeeding or pregnancy or unwillingness to use highly effective contraception
- Inability to comply with study procedures
- Any medical condition or organ dysfunction that may compromise safety or study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 71 locations
1
City of Hope (Adults and Pediatrics)
Duarte, California, United States, 91010
Completed
2
University of California San Diego Moores Cancer Center (Adults only)
La Jolla, California, United States, 92093
Completed
3
Loma Linda University Medical Center (Adults only)
Loma Linda, California, United States, 92354
Actively Recruiting
4
Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)
Los Angeles, California, United States, 90027
Actively Recruiting
5
UCLA Medical Center (Adults and Pediatrics)
Los Angeles, California, United States, 90095
Completed
6
University of California Davis Comprehensive Cancer Center (Adults only)
Sacramento, California, United States, 95817
Completed
7
Yale University (Adults and Pediatrics)
New Haven, Connecticut, United States, 06519
Completed
8
MedStar Georgetown University Hospital (Adults and Pediatrics)
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
9
University of Florida (Adults and Pediatrics)
Gainesville, Florida, United States, 32610
Completed
10
University of Miami/Jackson Memorial Hospital (Adults only)
Miami, Florida, United States, 33136
Actively Recruiting
11
Winship Cancer Institute (Adults only)
Atlanta, Georgia, United States, 30322
Completed
12
Arthur M. Blank Hospital (Pediatrics)
Atlanta, Georgia, United States, 30329
Actively Recruiting
13
Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)
Chicago, Illinois, United States, 60611
Actively Recruiting
14
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)
Chicago, Illinois, United States, 60637
Completed
15
Loyola University Medical Center (Adults and Pediatrics)
Maywood, Illinois, United States, 60153
Actively Recruiting
16
University of Maryland School of Medicine (Adults only)
Baltimore, Maryland, United States, 21201
Completed
17
Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
Washington University School of Medicine (Adults only)
St Louis, Missouri, United States, 63110
Actively Recruiting
19
Weill Cornell Medicine (Adults only)
New York, New York, United States, 10021
Completed
20
Columbia University Medical Center (Adults and Pediatrics)
New York, New York, United States, 10032
Completed
21
Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)
New York, New York, United States, 10065
Completed
22
Montefiore Medical Center (Adults only)
The Bronx, New York, United States, 10467
Completed
23
Montefiore Medical Center (Pediatrics only)
The Bronx, New York, United States, 10467
Completed
24
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)
Chapel Hill, North Carolina, United States, 27599
Completed
25
Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)
Charlotte, North Carolina, United States, 28204
Actively Recruiting
26
Duke Cancer Institute (Adults and Pediatrics)
Durham, North Carolina, United States, 27710
Actively Recruiting
27
Cleveland Clinic Foundation (Adults and Pediatrics)
Cleveland, Ohio, United States, 44195
Actively Recruiting
28
Nationwide Children's Hospital (Pediatrics only)
Columbus, Ohio, United States, 43205
Completed
29
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics)
Columbus, Ohio, United States, 43210
Actively Recruiting
30
Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)
Portland, Oregon, United States, 97239
Actively Recruiting
31
Hospital of the University of Pennsylvania (Adults only)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
32
The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
33
University of Pittsburgh Medical Center (Adults only)
Pittsburgh, Pennsylvania, United States, 15232
Completed
34
Medical University of South Carolina (Adults and Pediatrics)
Charleston, South Carolina, United States, 29425
Active, Not Recruiting
35
Saint Jude Children's Research Hospital (Pediatrics only)
Memphis, Tennessee, United States, 38105
Completed
36
Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)
Nashville, Tennessee, United States, 37232
Actively Recruiting
37
Baylor Scott and White Research Institute (Adults only)
Dallas, Texas, United States, 75246
Actively Recruiting
38
University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)
Dallas, Texas, United States, 75390
Actively Recruiting
39
MD Anderson Cancer Center (Pediatrics and Adult)
Houston, Texas, United States, 77030
Actively Recruiting
40
Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only)
Milwaukee, Wisconsin, United States, 53226
Completed
41
The Children's Hospital at Westmead (Pediatrics only)
Westmead, New South Wales, Australia, 2145
Actively Recruiting
42
Westmead Hospital (Adults only)
Westmead, New South Wales, Australia, 2145
Actively Recruiting
43
The Prince Charles Hospital (Adults only)
Chermside, Queensland, Australia, 4032
Actively Recruiting
44
Royal Adelaide Hospital (Adults only)
Adelaide, South Australia, Australia, 5000
Actively Recruiting
45
The Royal Children's Hospital Melbourne (Pediatrics only)
Melbourne, Victoria, Australia, 3052
Actively Recruiting
46
Fiona Stanley Hospital (Adults only)
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
47
Medizinische Universitat Wien (Adults only)
Vienna, Austria, Austria, 1090
Active, Not Recruiting
48
Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)
Liège, Brussels Capital, Belgium, 4000
Completed
49
Universitair Ziekenhuis Leuven (Adults and Pediatrics)
Leuven, Flemish Brabant, Belgium, 3000
Active, Not Recruiting
50
Alberta Children's Hospital (Adults and Pediatrics)
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
51
Sick Kids (Pediatrics only)
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
52
Princess Margaret Cancer Centre (Adults only)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
53
Centre Hospitalier Universitaire de Bordeaux (Adults only)
Pessac, Aquitaine, France, 33600
Completed
54
Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)
Lille, Hauts-de-France, France, 59037
Completed
55
Hôpital Necker-Enfants Malades (Pediatrics only)
Paris, Île-de-France Region, France, 75015
Completed
56
Hôpital Saint Antoine (Adults only)
Paris, Île-de-France Region, France, 75571
Completed
57
Hôpital Universitaire Pitié Salpêtrière (Adults only)
Paris, Île-de-France Region, France, 75651
Completed
58
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)
Milan, Milano, Italy, 20162
Completed
59
Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)
Pavia, Pavia, Italy, 27100
Completed
60
Fondazione Policlinico Universitario Agostino Gemelli (Adults only)
Roma, Roma, Italy, 00168
Completed
61
Ospedale Pediatrico Bambino Gesu (Pediatrics only)
Roma, Roma, Italy, 165
Completed
62
Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)
Torino, Torino, Italy, 10126
Completed
63
Hospital Duran i Reynals (Adults and Pediatrics)
Badalona, BARCELONA, Spain, 8908
Actively Recruiting
64
Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)
Barcelona, Barcelona, Spain, 08035
Suspended
65
Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)
Santander, Cantabria, Spain, 39008
Actively Recruiting
66
Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)
Madrid, Madrid, Spain, 28009
Actively Recruiting
67
University Hospital Virgen del Rocio (Adults and Pediatrics)
Seville, Spain, Spain, 41013
Actively Recruiting
68
Hospital Universitario La Fe (Adults and Pediatrics)
Valencia, Valencia, Spain, 46009
Actively Recruiting
69
University Hospitals Birmingham NHS Foundation Trust (Adults only)
Birmingham, England, United Kingdom, B15 2GW
Actively Recruiting
70
King's College Hospital NHS Foundation Trust (Adults only)
London, England, United Kingdom, SE5 9RS
Completed
71
Imperial College Healthcare NHS Trust (Adults only)
London, England, United Kingdom, W12 0HS
Actively Recruiting
Research Team
C
Claire Fabre
CONTACT
M
Marie Bosredon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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