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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Tabelecleucel for Solid Organ Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy

This is a multicenter, open-label, single-arm phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of solid organ transplant (SOT) after failure of rituximab or rituximab plus chemotherapy.
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

A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD with a pathology sample available for central review

Availability of appropriate HLA partially-matched and restricted tabelecleucel cell product

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

Treatment failure of rituximab monotherapy (Cohort A) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (Cohort B) for treatment of PTLD. Note: Subjects with CD20 negative disease are eligible to enroll without prior anti-CD20 therapy after failure of first-line treatment (reduction of immunosuppression is not considered first-line therapy) and discussion with the sponsor's medical monitor.

Males and females of any age

Eastern Cooperative Oncology Group (ECOG) performance status 16 years; Lansky score >= 20 for subjects from birth to 16 years

Adequate organ functions:

Absolute neutrophil count >= 1000/?L, with or without cytokine support

Platelet count >= 50,000/?L, with or without transfusion or cytokine support

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:

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

Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving treatment at enrollment

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 three drug half-lives from the most recent dose to Cycle 1 Day 1

Need for vasopressor or ventilatory support

Antithymocyte globulin or similar anti-T cell antibody therapy
Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor (CAR) T cells directed against B cells within 8 weeks of Cycle 1 Day 1

Pregnancy

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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