Health Trials

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

ConditionsEpstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)Solid Organ Transplant ComplicationsLymphoproliferative DisordersAllogeneic Hematopoietic Cell TransplantStem Cell Transplant Complications
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPierre Fabre Medicament

About this trial

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.

Eligibility criteria

Qualifiers

Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT).

A diagnosis of locally assessed, biopsy-proven EBV+ PTLD.

Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.

Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.

Disqualifiers

Currently active Burkitt, T-cell, NK/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.

Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis.

Untreated CNS PTLD or CNS PTLD for which the participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.

Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment.

Trial design

Treatments tested in this trial

  • tabelecleucel

Treatment groups

115 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Pierre Fabre Medicament

Lead sponsor

Source ClinicalTrials.gov