← Klinické štúdie • Transplantácia obličky
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
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
Stručný súhrn
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.
Základné údaje
| Ochorenia | Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant, Stem Cell Transplant Complications |
|---|---|
| Intervencie | BIOLOGICAL: tabelecleucel |
| Sponzor | Pierre Fabre Medicament |
| Plánovaný počet | 115 |
| Začiatok | 2017-12-29 |
| Predp. ukončenie (primárne) | 2030-05-31 |
| Krajiny | United States, Australia, Austria, Belgium, Canada, France, Italy, Spain, United Kingdom |
| Posledná aktualizácia | 2026-05-22 |