Clinical Trial

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

Study acronym: ALLELE
Recruiting Phase 3
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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.
Protocol Amendment History 57 amendments
This ClinicalTrials.gov record has been amended 57 times since 2018-01-04; most recent amendment 2026-05-20.
Trial Details
NCT Number NCT03394365
Lead Sponsor Pierre Fabre Medicament
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
Enrollment 115 participants
Start Date 2017-12-29
Primary Completion 2030-05-31 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-31