Trial Profile
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
Status:
Suspended
Phase of Trial:
Phase III
Latest Information Update: 22 Apr 2025
Price :
$35
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At a glance
- Drugs Tabelecleucel (Primary)
- Indications Diffuse large B cell lymphoma; Lymphoproliferative disorders
- Focus Registrational; Therapeutic Use
- Acronyms ALLELE
- Sponsors Atara Biotherapeutics
- 21 Jan 2025 Status changed from recruiting to suspended. The U.S. FDA has placed a clinical hold which is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection. Specifically identified subjects currently enrolled in the clinical study who have the potential to derive clinical benefit may continue to receive treatment in accordance with the ongoing study protocol but screening and enrollment of new participants have been paused.
- 16 Jan 2025 According to an Atara Biotherapeutics media release, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLOTM (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen.
- 07 Dec 2024 Results presented in a Pierre Fabre Media Release.