A Phase III Study of Tabelecleucel Immunotherapy to Treat Epstein-Barr Virus-Associated Lymphoproliferative Disease after Failure of Rituximab and/or Chemotherapy Treatment in Patients Who Had a Solid Organ Transplant

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Full Title

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)

Purpose

Some patients who have had a solid organ transplant (such as a heart or lung transplant) develop lymphoproliferative disease associated with Epstein-Barr virus (EBV), a common virus that usually causes no significant problems but which can be more serious in people taking immunosuppressive medications after a transplant. In this study, researchers are assessing the effectiveness of an investigational immunotherapy called tabelecleucel in patients with EBV-related lymphoproliferative disease after a solid organ transplant which persists despite treatment with rituximab, with or without chemotherapy.

Tabelecleucel is a cellular therapy. It is made of white blood cells called cytotoxic T lymphocytes (CTLs) which have been expanded in the laboratory starting with cells from a healthy person who is immune to EBV. The cells recognize and destroy EBV-infected cells in the transplant recipient. Patients receive EBV-CTLs from a partially matched donor. Tabelecleucel is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have EBV-associated lymphoproliferative disease following receipt of a kidney, liver, heart, lung, pancreas, or small bowel transplant, or any combination of these.
  • Patients’ EBV-associated lymphoproliferative disease must persist despite treatment with rituximab alone or with chemotherapy.
  • This study is open to patients of all ages.

For more information about this study and to inquire about eligibility, please contact Dr. Susan Prockop at 212-639-6715.

Protocol

18-074

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators