Spots Global Cancer Trial Database for Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy
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Trial Identification
Brief Title: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy
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
Study ID: NCT03394365
Interventions
Study Description
Brief 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 and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.
Detailed Description: This is a multicenter, open-label, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of SOT after failure of rituximab and rituximab plus chemotherapy (SOT cohort) or HCT after failure of rituximab (HCT cohort). Enrollment will be preceded by confirmation of availability of partially human leukocyte antigen (HLA) matched and restricted tabelecleucel for the participant. Study procedures and product administration will be the same for each cohort. Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, participants will receive intravenous tabelecleucel at a dose of 2×10\^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35. Treatment will continue until maximal response, unacceptable toxicity, initiation of non protocol therapy, or failure of tabelecleucel with up to 2 different HLA restrictions (SOT cohort) or up to 4 different HLA restrictions (HCT cohort). The study includes a total of 5 years of follow-up for disease and survival status. This protocol has been amended to include the HCT cohort from clinical study ATA129-EBV-301 (NCT03392142). NOTE, 29 April 2020: Enrollment is temporarily paused at study site/locations with status "active, not recruiting" due to COVID-19 restrictions.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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 Cancer 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, 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
Children's Healthcare of Atlanta at Egleston (Pediatrics), Atlanta, Georgia, United States
Winship Cancer Institute of Emory University (Adults only), 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), Saint Louis, Missouri, United States
Montefiore Medical Center (Adults only), Bronx, New York, United States
Montefiore Medical Center (Pediatrics only), Bronx, New York, 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
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 only), 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
The Ohio State University - Arthur G. James Cancer Center Hospital (Adults and Pediatrics), Columbus, Ohio, United States
Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics), Portland, Oregon, United States
Children's Hospital of Philadelphia (Pediatrics only), Philadelphia, Pennsylvania, United States
University of Pennsylvania (Adults only), 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 (Adults and Pediatrics), Houston, Texas, United States
Froedtert Hospital & the Medical College of Wisconsin (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), Wien, , Austria
Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics), Liège, Brussels, 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
Groupe Hospitalier du Haut Leveque (Adults only), Pessac, Aquitaine, France
Hôpital Saint Antoine (Adults only), Paris, Ile-de-France, France
Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics), Lille cedex, Nord-Pas-de-Calais, France
Hôpital Necker-Enfants Malades (Pediatrics only), Paris 15, Île-de-France, France
Hôpital Universitaire Pitié Salpêtrière (Adults only), Paris Cedex 13, Île-de-France, France
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only), Milano, , Italy
Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics), Pavia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli (Adults only), Roma, , Italy
Ospedale Pediatrico Bambino Gesu (Pediatrics only), Roma, , Italy
Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only), Torino, , Italy
Hospital Duran i Reynals, Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics), Santander, Cantabria, Spain
Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics), Barcelona, , Spain
Hospital General Universitario Gregorio Marañón (Adults and Pediatrics), Madrid, , Spain
University Hospital Virgen del Rocio (Adults and Pediatrics), Sevilla, , Spain
Hospital Universitario La Fe (Adults and Pediatrics), 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
Contact Details
Name: Aditi Mehta, DO
Affiliation: Atara Biotherapeutics
Role: STUDY_DIRECTOR
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