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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
NCT03394365 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL tabelecleucel
Study Locations (20)
California
- City of Hope (Adults and Pediatrics) — Duarte
- University of California San Diego Moores Cancer Center (Adults only) — La Jolla
- Loma Linda University Medical Center (Adults only) — Loma Linda
- Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics) — Los Angeles
- UCLA Medical Center (Adults and Pediatrics) — Los Angeles
- University of California Davis Comprehensive Cancer Center (Adults only) — Sacramento
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics) — Chicago
- University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only) — Chicago
- Loyola University Medical Center (Adults and Pediatrics) — Maywood
Florida
- University of Florida (Adults and Pediatrics) — Gainesville
- University of Miami/Jackson Memorial Hospital (Adults only) — Miami
Georgia
- Winship Cancer Institute (Adults only) — Atlanta
- Arthur M. Blank Hospital (Pediatrics) — Atlanta
New York
- Weill Cornell Medicine (Adults only) — New York
- Columbia University Medical Center (Adults and Pediatrics) — New York
Connecticut
- Yale University (Adults and Pediatrics) — New Haven
District of Columbia
- MedStar Georgetown University Hospital (Adults and Pediatrics) — Washington D.C.
Maryland
- University of Maryland School of Medicine (Adults only) — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2017-12-29 |
| Est. Completion | 2030-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03394365
The ClinicalTrials.gov registry entry for NCT03394365 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pierre Fabre Medicament, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Stem Cell Transplant Complications appearing as the primary indexed condition, and to 1 intervention — of which tabelecleucel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03394365 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03394365 about?
NCT03394365 is a clinical study titled "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". 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...
What is the current status of trial NCT03394365?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 115 participants. The study started on 2017-12-29. Estimated completion is 2030-08.
What conditions does trial NCT03394365 study?
This clinical trial studies the following conditions: Stem Cell Transplant Complications, Lymphoproliferative Disorders, Solid Organ Transplant Complications, Allogeneic Hematopoietic Cell Transplant, Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03394365?
The interventions under investigation include: tabelecleucel (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03394365?
This trial is sponsored by Pierre Fabre Medicament, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03394365 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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