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

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.

Disease Sites:

Hematologic

Staging:

Phase III

Age Group:

Both

Therapies:

Mol. targeted/Immunotherapy/Biologics

Drugs:

Tabelecleucel

Principal Investigator(s):

Dholaria, Bhagirathbhai

Scope:

National

Participating Institutions:

Vanderbilt University

Open Date:

04-12-2019

Trial Type:

Treatment

Protocol ID:

VICCCTT1875

National Clinical Trial ID:

NCT03394365

Eligibility

Ages Eligible for Study:

Not Available

Genders Eligible for Study:

ALL

Accepts Healthy Volunteers?:

false

Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

Eligibility