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RECRUITING

NCT03394365

PHASE3

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

View on ClinicalTrials.gov

Summary

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.

Official title: Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2017-12-29

Completion Date

2030-08

Last Updated

2026-02-20

Healthy Volunteers

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

Interventions

BIOLOGICAL

tabelecleucel

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

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), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head 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 of rituximab or interchangeable commercially available biosimilar monotherapy (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (C-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.

Locations (71)

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 (Pediatrics)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)