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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab

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 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
VICCBMT1876
NCT03392142

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

Prior allogeneic hematopoietic cell transplant

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

Availability of appropriate partially HLA-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). Baseline scans must be of acceptable quality to the central radiology laboratory prior to Cycle 1 Day 1.

Failure of rituximab for first-line 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

Underlying primary disease, for which the subject underwent transplant, is in morphologic remission

Adequate organ function

Absolute neutrophil count >= 500/µL, with or without cytokine support

Platelet count >= 50,000/µL, with or without transfusion support; platelet count = 20,000/µL, with or without transfusion support, is permissible if the subject has not had Grade >= 2 bleeding in the prior 6 months (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)

Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) each
Creatinine
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

History of central nervous system (CNS) PTLD

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 (eg, nivolumab, pembrolizumab, ipilimumab) within three drug half-lives from the most recent dose to Cycle 1 Day 1

Active adenovirus viremia

Need for vasopressor or ventilatory support

Antithymocyte globulin or similar anti-T cell antibody therapy
Treatment with Epstein-Barr virus cytotoxic T lymphocytes, chimeric antigen receptor (CAR)-T cells directed against B cells, or unselected donor lymphocyte infusion (DLI) 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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