Trial Profile
Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 06 Nov 2021
Price :
$35
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At a glance
- Drugs Tabelecleucel (Primary)
- Indications Lymphoproliferative disorders
- Focus Registrational; Therapeutic Use
- Acronyms MATCH
- Sponsors Atara Biotherapeutics
- 24 Mar 2021 Status changed from recruiting to completed.
- 10 Jan 2021 According to an Atara Biotherapeutics media release, the company expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the European Union (EU) for patients with EBV+ PTLD in Q4 2021. EU approval of MAA for patients with EBV+ PTLD is anticipated in H2 2022.
- 09 May 2019 According to an Atara Biotherapeutics media release, enrollment is this study is proceeding slower than anticipated. The company plans to submit a conditional marketing authorization (CMA) application for tab-cel based on initial Phase 3 results in 2020.