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
NCT ID: NCT03394365
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
115 participants
INTERVENTIONAL
2017-12-29
2030-08-31
Brief Summary
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Detailed Description
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SOT-R further included participants:
1. who did not receive chemotherapy and did not have a documented medical reason not to receive chemotherapy (SOT-Ro) or
2. who were considered chemotherapy ineligible/inappropriate (SOT-R-Ci)
Combined population (SOT-R-Ci, SOT-R+C, and HCT) and (SOT-R-Ci and SOT-R+C) who received commercial product, or a product manufactured using a comparable process version (PV) were also used for analysis of outcomes.
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 (C-SOT) or up to 4 different HLA restrictions (C-HCT). The study includes a total of 5 years of follow-up for disease and survival status for participants enrolled before or after 09 October 2023 to reach the initial sample size of 33 participants in both cohorts. For all other participants enrolled after 09 October 2023 and after the initial sample of 33 participants in both cohorts has been reached in both cohorts, the follow-up will be every 3 months, up to 12 months, as assessed on anniversary of Cycle 1 Day 1. For responders, the follow-up will be 12 months from the date of initial response.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort SOT-R (C-SOT-R)
Participants with EBV+ PTLD following SOT that has failed rituximab will receive IV tabelecleucel.
tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Cohort SOT-R+C (C-SOT-R+C)
Participants with EBV+ PTLD following SOT that has failed both rituximab and chemotherapy will receive IV tabelecleucel.
tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Cohort HCT (C-HCT)
Participants with EBV+ PTLD following HCT that has failed rituximab containing regimen will receive IV tabelecleucel.
tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Interventions
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tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Anke Friedetzky
Role: STUDY_DIRECTOR
Pierre Fabre Laboratories
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Sajad Khazal, MD
Role: primary
Amber Medina
Role: primary
Neena Kapoor, MD
Role: backup
Udeme Ekong, MD
Role: primary
Amer Beitinjaneh, MD, MPH, MSc
Role: primary
Suhag Parikh, MD
Role: primary
Sonali Chaudhury, MD
Role: primary
Patrick Hagen, MD
Role: primary
Sarah Nikiforow, MD
Role: primary
Armin Ghobadi, MD
Role: primary
Michael Kent, MD
Role: primary
Matthew McKinney, MD
Role: primary
Rabi Hanna, MD
Role: primary
Robert Baiocchi, MD, PhD
Role: primary
Andy Chen, MD
Role: primary
Sunita Nasta, MD
Role: primary
Caitlin Elgarten, MD
Role: primary
Bhagirathbhai Dholaria, MD
Role: primary
Luis Pineiro, MD
Role: primary
Tamra Slone, MD
Role: primary
Priti Tewari, MD
Role: primary
Caroline Bateman, MD
Role: primary
Shyam Panicker, MD, MBBS, MRCP, FRACP, FRCPA
Role: primary
Chandima Divithotawela, MBBS, FRACP
Role: primary
Devendra Hiwase, MD
Role: primary
Theresa Cole, BM, MRCPCH, FRACP
Role: primary
Duncan Purtill, MD, MBBS, FRACP, FRCPA
Role: primary
Victor Lewis, MD
Role: primary
Joerg Krueger, MD
Role: primary
Igor Novitzky Basso, MD
Role: primary
Eva González-Barca, MD
Role: primary
Lucrecia Yanez, MD
Role: primary
Rebeca Bailen, MD
Role: primary
Jose Perez-Simon, MD
Role: primary
Juan Montoro, MD
Role: primary
Sridhar Chaganti, MD
Role: primary
Eduardo Olavarria, MD
Role: primary
References
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Mahadeo KM, Baiocchi R, Beitinjaneh A, Chaganti S, Choquet S, Dierickx D, Dinavahi R, Duan X, Gamelin L, Ghobadi A, Guzman-Becerra N, Joshi M, Mehta A, Navarro WH, Nikiforow S, O'Reilly RJ, Reshef R, Ruiz F, Spindler T, Prockop S. Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial. Lancet Oncol. 2024 Mar;25(3):376-387. doi: 10.1016/S1470-2045(23)00649-6. Epub 2024 Jan 31.
Other Identifiers
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2024-516622-57-00
Identifier Type: CTIS
Identifier Source: secondary_id
ATA129-EBV-302/F60085DL302
Identifier Type: -
Identifier Source: org_study_id
NCT03392142
Identifier Type: -
Identifier Source: nct_alias
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