Phase 3 Study of Tabelecleucel for EBV-Associated PTLD
This study is testing a treatment called tabelecleucel for people with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD). This condition can happen after a solid organ transplant (SOT) or a stem cell transplant (HCT). Participants in this study have already tried rituximab, or rituximab and chemotherapy, and these treatments didn't work. Tabelecleucel is a type of immunotherapy that uses special cells to fight the disease. The main goal is to see how many participants respond to tabelecleucel, and to understand its safety. You might be able to join if you've had a solid organ or stem cell transplant, have a confirmed diagnosis of EBV+ PTLD, and a suitable tabelecleucel product is available for you. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase 3, open-label study, meaning both you and your doctors will know you are receiving tabelecleucel. It plans to enroll 115 participants.
- What's involved
- You would receive tabelecleucel intravenously (through a vein) on Days 1, 8, and 15 of each 5-week cycle. Treatment continues until the best response is achieved, side effects are too severe, other treatments are started, or tabelecleucel is no longer effective.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main results will be measured up to 2 years after treatment to see how well tabelecleucel worked.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
71 sites across 42 statesWho to contact
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What this trial measures
- Objective Response Rate (ORR) in the Analysis Cohorts C-SOT, C-HCT, and Combined Population (C-SOT-R+C, C-SOT-R-Ci, and C-HCT) Who Received Commercial Product, or a Product Manufactured Using a Comparable PV2 years