EBV+ associated lymphoproliferative disease in the setting of acquired (non-congenital) immunodeficiency (EBV+ AID LPD), EBV+ associated post-transplant LPD involving the central nervous system (EBV+ CNS PTLD), EBV+ post-transplant LPD where standard first line therapy (rituximab or chemotherapy) is inappropriate, EBV+ primary imunodeficiency lymphoproliferative disease (LPD), EBV+ sarcomas, including CD20-negative disease, including leiomyosarcoma, or smooth muscle tumors
Conditions
Brief summary
The ORR obtained following administration of tabelecleucel with the first two different human leukocyte antigen (HLA) restrictions
Detailed description
Overall survival (OS), Duration of response (DOR), Progression-free survival (PFS), For EBV-associated lymphoproliferative disease in the setting of primary imunodeficiency (EBV+ PID LPD) cohort:Number of subjects who reach definitive therapy (i.e., allogeneic HCT) for the underlying disease. Time to definitive therapy., For EBV+ sarcoma cohort, including leiomyosarcoma (LMS), or smooth muscle tumors: Clinical benefit rate. ORR by immune response evaluation criteria in solid tumors (iRECIST) criteria [Seymour 2017]
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ORR obtained following administration of tabelecleucel with the first two different human leukocyte antigen (HLA) restrictions | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Duration of response (DOR), Progression-free survival (PFS), For EBV-associated lymphoproliferative disease in the setting of primary imunodeficiency (EBV+ PID LPD) cohort:Number of subjects who reach definitive therapy (i.e., allogeneic HCT) for the underlying disease. Time to definitive therapy., For EBV+ sarcoma cohort, including leiomyosarcoma (LMS), or smooth muscle tumors: Clinical benefit rate. ORR by immune response evaluation criteria in solid tumors (iRECIST) criteria [Seymour 2017] | — |
Countries
Austria, Belgium, France, Italy, Spain