Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
Trial ID or NCT#
NCT02822495
Status
NOT RECRUITING
Purpose
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
Official Title
Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
Eligibility Criteria
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Any of the following diagnoses of EBV+ malignancies or disease: 1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) 2. EBV+ PTLD following solid organ transplant (SOT) 3. Persistent EBV viremia and known or suspected immunodeficiency 4. EBV+ LPD that has developed in the setting of an AID 5. EBV+ LPD that has developed in the setting of a known or suspected PID 6. EBV+ LMS 7. EBV+ NPC 2. The evidence of EBV positivity 3. Relapsed or refractory disease, defined as failure to achieve response (ie, complete response or partial response) or recurrent disease following first line therapy, ie, systemic therapy for EBV-related malignancy or viremia for which there are no appropriate therapies. 4. Not eligible for any other Atara clinical development study 5. For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be in morphologic remission 6. Adequate organ function per the following: 1. Absolute neutrophil count >= 500/μL, with or without cytokine support 2. Platelet count >= 20,000/μL, with or without transfusion support 7. Participant or participant's representative is willing and able to provide written informed consent
Exclusion Criteria:
- 1. Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma 2. Prior treatment with any investigational product within 4 weeks of first treatment with tabelecleucel, or within 5 half-lives from the most recent dose to first treatment with tabelecleucel 3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or equivalent) 4. Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat 5. Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or T-cell immunotherapy (donor lymphocyte infusion, other cytotoxic T lymphocytes [CTLs]) <= 4 weeks prior to first treatment with tabelecleucel 6. Pregnancy 7. Female of childbearing potential or male with a female partner of childbearing potential, either of whom are unwilling to use a highly effective method of contraception
Investigator(s)
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Lymphoma specialist,
Medical oncologist,
Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Andrew Rezvani, M.D.
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Medical oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lori Muffly
Hematologist,
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Lowsky
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Medical oncologist,
Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
