RecruitingPhase 3NCT03394365

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

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

Sponsor

Pierre Fabre Medicament

Enrollment

115 participants

Start Date

Dec 29, 2017

Study Type

INTERVENTIONAL

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

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment called tabelecleucel — a type of immune cell therapy using donor T-cells trained to fight the Epstein-Barr virus — for patients who developed a rare complication called post-transplant lymphoproliferative disease (PTLD, a type of lymphoma) after a solid organ or bone marrow transplant, and whose condition did not respond to standard treatments. **You may be eligible if...** - You previously received a solid organ transplant (kidney, liver, heart, lung, pancreas, small bowel, or combination) or an allogeneic stem cell or bone marrow transplant - You have been diagnosed with EBV-positive PTLD (a type of lymphoma triggered by the Epstein-Barr virus after transplant), confirmed by biopsy - The appropriate matched tabelecleucel product is available for you through the sponsor - Your disease is measurable by PET-CT imaging **You may NOT be eligible if...** - You have not received a transplant - Your PTLD is EBV-negative - You have not yet tried rituximab (the standard first treatment) - Your overall health is too poor to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALtabelecleucel

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

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

View Full Details on ClinicalTrials.gov

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NCT03394365

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