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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

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

View All Criteria

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

Assistant 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)

CONTACT

CCTO
(650) 498-7061

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View on ClinicalTrials.gov

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Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To:

New to MyHealth?

ALREADY HAVE AN ACCESS CODE?

DON'T HAVE AN ACCESS CODE?

NEED MORE DETAILS?

MyHealth for Mobile

WELCOME BACK

Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: