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
Public ClinicalTrials.gov record NCT03394365. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03394365
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 115 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2017
- Primary completion
- May 30, 2030
- Completion
- Jul 31, 2030
- Last update posted
- Sep 1, 2026
2017 – 2030
United States locations
- U.S. sites
- 40
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope (Adults and Pediatrics) | Duarte | California | 91010 | Completed |
| University of California San Diego Moores Cancer Center (Adults only) | La Jolla | California | 92093 | Completed |
| Loma Linda University Medical Center (Adults only) | Loma Linda | California | 92354 | Recruiting |
| Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics) | Los Angeles | California | 90027 | Recruiting |
| UCLA Medical Center (Adults and Pediatrics) | Los Angeles | California | 90095 | Completed |
| University of California Davis Comprehensive Cancer Center (Adults only) | Sacramento | California | 95817 | Completed |
| Yale University (Adults and Pediatrics) | New Haven | Connecticut | 06519 | Completed |
| MedStar Georgetown University Hospital (Adults and Pediatrics) | Washington D.C. | District of Columbia | 20007 | Recruiting |
| University of Florida (Adults and Pediatrics) | Gainesville | Florida | 32610 | Completed |
| University of Miami/Jackson Memorial Hospital (Adults only) | Miami | Florida | 33136 | Recruiting |
| Winship Cancer Institute (Adults only) | Atlanta | Georgia | 30322 | Completed |
| Arthur M Blank Hospital - Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | Recruiting |
| Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics) | Chicago | Illinois | 60611 | Recruiting |
| University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only) | Chicago | Illinois | 60637 | Completed |
| Loyola University Medical Center (Adults and Pediatrics) | Maywood | Illinois | 60153 | Recruiting |
| University of Maryland School of Medicine (Adults only) | Baltimore | Maryland | 21201 | Completed |
| Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics) | Boston | Massachusetts | 02215 | Recruiting |
| Washington University School of Medicine (Adults only) | St Louis | Missouri | 63110 | Recruiting |
| Weill Cornell Medicine (Adults only) | New York | New York | 10021 | Completed |
| Columbia University Medical Center (Adults and Pediatrics) | New York | New York | 10032 | Completed |
| Memorial Sloan Kettering Cancer Center (Adults and Pediatrics) | New York | New York | 10065 | Completed |
| Montefiore Medical Center (Adults only) | The Bronx | New York | 10467 | Completed |
| Montefiore Medical Center (Pediatrics only) | The Bronx | New York | 10467 | Completed |
| University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics) | Chapel Hill | North Carolina | 27599 | Completed |
| Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics) | Charlotte | North Carolina | 28204 | Recruiting |
| Duke Cancer Institute (Adults and Pediatrics) | Durham | North Carolina | 27710 | Recruiting |
| Cleveland Clinic Foundation (Adults and Pediatrics) | Cleveland | Ohio | 44195 | Recruiting |
| Nationwide Children's Hospital (Pediatrics only) | Columbus | Ohio | 43205 | Completed |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics) | Columbus | Ohio | 43210 | Recruiting |
| Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics) | Portland | Oregon | 97239 | Recruiting |
| Hospital of the University of Pennsylvania (Adults only) | Philadelphia | Pennsylvania | 19104 | Recruiting |
| The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics) | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University of Pittsburgh Medical Center (Adults only) | Pittsburgh | Pennsylvania | 15232 | Completed |
| Medical University of South Carolina (Adults and Pediatrics) | Charleston | South Carolina | 29425 | Completed |
| Saint Jude Children's Research Hospital (Pediatrics only) | Memphis | Tennessee | 38105 | Completed |
| Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics) | Nashville | Tennessee | 37232 | Recruiting |
| Baylor Scott and White Research Institute (Adults only) | Dallas | Texas | 75246 | Recruiting |
| University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only) | Dallas | Texas | 75390 | Recruiting |
| MD Anderson Cancer Center (Pediatrics and Adult) | Houston | Texas | 77030 | Recruiting |
| Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only) | Milwaukee | Wisconsin | 53226 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03394365, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03394365 live on ClinicalTrials.gov.