N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pierre Fabre Medicament • ClinicalTrials.gov ID: NCT03394365

Registry updated: 2026-10-19
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • tabelecleucel (Biological)
    Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Eligibility criteria

Inclusion Criteria: 1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT). 2. A diagnosis of locally assessed, biopsy-proven EBV+ PTLD. 3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor. 4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT). Magnetic resonance imaging (MRI) may be used when PET-CT is contraindicated, mandated by local practice, or when disease status cannot be assessed adequately in the investigator's opinion and is confirmed by the Sponsor. For participants with treated CNS disease, a head diagnostic CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria. 5. Treatment failure to CD20-directed antibody, i.e. rituximab or interchangeable commercially available biosimilar monotherapy (SOT-R or HCT cohort) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (SOT-R+C) for treatment of PTLD. 6. Males and females of any age. 7. Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants \< 16 years. 8. For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the participant underwent transplant must be in morphologic remission. 9. Adequate organ function. 1. Absolute neutrophil count ≥ 1000/μL, (C-SOT) or ≥ 500/μL (C-HCT), with or without cytokine support. 2. 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 without transfusion support, is permissible if the participant has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0). 3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each \< 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction. 10. Participant or participant's representative is willing and able to provide written informed consent. Exclusion Criteria: 1. Currently active Burkitt, T-cell, NK/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy. 2. Daily steroids of \> 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis. 3. Untreated CNS PTLD or CNS PTLD for which the participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete. 4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment. 5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment. 6. For C-HCT: active adenovirus viremia. 7. Need for vasopressor or ventilatory support. 8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment. 9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (C-SOT or C-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCT only). 10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception. 11. Inability to comply with study-related procedures. 12. Any medical condition or organ system dysfunction that in the investigator';s opinion, could compromise the participant's safety or ability to complete the study.

Conditions

Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) Solid Organ Transplant Complications Lymphoproliferative Disorders Allogeneic Hematopoietic Cell Transplant Stem Cell Transplant Complications

Locations

  • City of Hope (Adults and Pediatrics) — Duarte, California, United States
  • University of California San Diego Moores Cancer Center (Adults only) — La Jolla, California, United States
  • Loma Linda University Medical Center (Adults only) — Loma Linda, California, United States
  • Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics) — Los Angeles, California, United States
  • UCLA Medical Center (Adults and Pediatrics) — Los Angeles, California, United States
  • University of California Davis Comprehensive Cancer Center (Adults only) — Sacramento, California, United States
  • Yale University (Adults and Pediatrics) — New Haven, Connecticut, United States
  • MedStar Georgetown University Hospital (Adults and Pediatrics) — Washington D.C., District of Columbia, United States
  • University of Florida (Adults and Pediatrics) — Gainesville, Florida, United States
  • University of Miami/Jackson Memorial Hospital (Adults only) — Miami, Florida, United States
  • Winship Cancer Institute (Adults only) — Atlanta, Georgia, United States
  • Arthur M Blank Hospital - Children's Healthcare of Atlanta — Atlanta, Georgia, United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics) — Chicago, Illinois, United States
  • University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only) — Chicago, Illinois, United States
  • Loyola University Medical Center (Adults and Pediatrics) — Maywood, Illinois, United States
  • University of Maryland School of Medicine (Adults only) — Baltimore, Maryland, United States
  • Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics) — Boston, Massachusetts, United States
  • Washington University School of Medicine (Adults only) — St Louis, Missouri, United States
  • Weill Cornell Medicine (Adults only) — New York, New York, United States
  • Columbia University Medical Center (Adults and Pediatrics) — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center (Adults and Pediatrics) — New York, New York, United States
  • Montefiore Medical Center (Adults only) — The Bronx, New York, United States
  • Montefiore Medical Center (Pediatrics only) — The Bronx, New York, United States
  • University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics) — Chapel Hill, North Carolina, United States
  • Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics) — Charlotte, North Carolina, United States
  • Duke Cancer Institute (Adults and Pediatrics) — Durham, North Carolina, United States
  • Cleveland Clinic Foundation (Adults and Pediatrics) — Cleveland, Ohio, United States
  • Nationwide Children's Hospital (Pediatrics only) — Columbus, Ohio, United States
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics) — Columbus, Ohio, United States
  • Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics) — Portland, Oregon, United States
  • Hospital of the University of Pennsylvania (Adults only) — Philadelphia, Pennsylvania, United States
  • The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics) — Philadelphia, Pennsylvania, United States
  • University of Pittsburgh Medical Center (Adults only) — Pittsburgh, Pennsylvania, United States
  • Medical University of South Carolina (Adults and Pediatrics) — Charleston, South Carolina, United States
  • Saint Jude Children's Research Hospital (Pediatrics only) — Memphis, Tennessee, United States
  • Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics) — Nashville, Tennessee, United States
  • Baylor Scott and White Research Institute (Adults only) — Dallas, Texas, United States
  • University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only) — Dallas, Texas, United States
  • MD Anderson Cancer Center (Pediatrics and Adult) — Houston, Texas, United States
  • Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only) — Milwaukee, Wisconsin, United States
  • The Children's Hospital at Westmead (Pediatrics only) — Westmead, New South Wales, Australia
  • Westmead Hospital (Adults only) — Westmead, New South Wales, Australia
  • The Prince Charles Hospital (Adults only) — Chermside, Queensland, Australia
  • Royal Adelaide Hospital (Adults only) — Adelaide, South Australia, Australia
  • The Royal Children's Hospital Melbourne (Pediatrics only) — Melbourne, Victoria, Australia
  • Fiona Stanley Hospital (Adults only) — Murdoch, Western Australia, Australia
  • Medizinische Universitat Wien (Adults only) — Vienna, Austria, Austria
  • Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics) — Liège, Brussels Capital, Belgium
  • Universitair Ziekenhuis Leuven (Adults and Pediatrics) — Leuven, Flemish Brabant, Belgium
  • Alberta Children's Hospital (Adults and Pediatrics) — Calgary, Alberta, Canada
  • Sick Kids (Pediatrics only) — Toronto, Ontario, Canada
  • Princess Margaret Cancer Centre (Adults only) — Toronto, Ontario, Canada
  • Centre Hospitalier Universitaire de Bordeaux (Adults only) — Pessac, Aquitaine, France
  • Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics) — Lille, Hauts-de-France, France
  • Hôpital Necker-Enfants Malades (Pediatrics only) — Paris, Île-de-France Region, France
  • Hôpital Saint Antoine (Adults only) — Paris, Île-de-France Region, France
  • Hôpital Universitaire Pitié Salpêtrière (Adults only) — Paris, Île-de-France Region, France
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only) — Milan, Milano, Italy
  • Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics) — Pavia, Pavia, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli (Adults only) — Roma, Roma, Italy
  • Ospedale Pediatrico Bambino Gesu (Pediatrics only) — Roma, Roma, Italy
  • Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only) — Torino, Torino, Italy
  • Hospital Duran i Reynals (Adults and Pediatrics) — Badalona, BARCELONA, Spain
  • Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics) — Barcelona, Barcelona, Spain
  • Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics) — Santander, Cantabria, Spain
  • Hospital General Universitario Gregorio Marañón (Adults and Pediatrics) — Madrid, Madrid, Spain
  • University Hospital Virgen del Rocio (Adults and Pediatrics) — Seville, Spain, Spain
  • Hospital Universitario La Fe (Adults and Pediatrics) — Valencia, Valencia, Spain
  • University Hospitals Birmingham NHS Foundation Trust (Adults only) — Birmingham, England, United Kingdom
  • King's College Hospital NHS Foundation Trust (Adults only) — London, England, United Kingdom
  • Imperial College Healthcare NHS Trust (Adults only) — London, England, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record