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Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of 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 and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.
Not Available
Phase III
Both
Not Available
Not Available
Satyanarayana, Gowri
National
Vanderbilt University
04-12-2019
Treatment
VICCBMT1875
NCT03394365

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

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

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 subjects 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.

Treatment failure of rituximab monotherapy (SOT cohort, subgroup A or HCT cohort) or rituximab plus chemotherapy (SOT cohort, subgroup B) for treatment of PTLD.

Eastern Cooperative Oncology Group performance status ? 3 for subjects aged > 16 years; Lansky score ? 20 for subjects from birth to 16 years

For HCT cohort only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the subject underwent transplant must be in morphologic remission

Adequate organ function

Absolute neutrophil count ? 1000/?L, (SOT cohort) or ? 500/?L (HCT cohort), with or without cytokine support

Platelet count ? 50,000/?L, with or without transfusion or cytokine support. For HCT cohort, platelet count
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) each
Subject or subject's representative is willing and able to provide written informed consent



Exclusion Criteria:

Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma

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 subject is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE:Subjects 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 (CIBMTR) consensus grading system at enrollment

Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment

For HCT cohort: active adenovirus viremia

Need for vasopressor or ventilatory support

Antithymocyte globulin or similar anti-T cell antibody therapy ? 4 weeks prior to enrollment

Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor (CAR) T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts), or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only)

Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception

Inability to comply with study-related procedures

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