- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822495
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
June 13, 2023 updated by: Atara Biotherapeutics
Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
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.
Study Overview
Status
No longer available
Conditions
- Lymphoproliferative Disorders
- Stem Cell Transplant Complications
- Epstein-Barr Virus (EBV) Infections
- EBV+ Associated Lymphoma
- EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Epstein-Barr Viremia
- Lymphoma, AIDS-related
- Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Primary Immunodeficiency (PID)
- Leiomyosarcoma (LMS)
- Nasopharyngeal Carcinoma (NPC)
- Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Acquired Immunodeficiency (AID)
- Solid Organ Transplant Complications
Intervention / Treatment
Detailed Description
Participants for whom there are no other appropriate therapeutic options and who are not eligible to enroll in other tabelecleucel clinical studies, may be enrolled in this study.
After the screening period, participants will receive intravenous infusions of tabelecleucel (1.6 to 2 × 10^6cells/kg) on Day 1, Day 8, and Day 15 of every 35-day cycle.
Clinical assessment of disease response is recommended approximately 15 days after the last dose of tabelecleucel to assess the need for additional treatment.
The end of expanded access protocol (EAP) visit should be performed at 30 days after the last dose of tabelecleucel.
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
Any of the following diagnoses of EBV+ malignancies or disease:
- EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
- EBV+ PTLD following solid organ transplant (SOT)
- Persistent EBV viremia and known or suspected immunodeficiency
- EBV+ LPD that has developed in the setting of an AID
- EBV+ LPD that has developed in the setting of a known or suspected PID
- EBV+ LMS
- EBV+ NPC
- The evidence of EBV positivity
- 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.
- Not eligible for any other Atara clinical development study
- For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be in morphologic remission
Adequate organ function per the following:
- Absolute neutrophil count >= 500/μL, with or without cytokine support
- Platelet count >= 20,000/μL, with or without transfusion support
- Participant or participant's representative is willing and able to provide written informed consent
Exclusion Criteria:
- Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma
- 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
- Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or equivalent)
- Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat
- 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
- Pregnancy
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aditi Mehta, DO, Atara Biotherapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 30, 2016
First Submitted That Met QC Criteria
July 1, 2016
First Posted (Estimated)
July 4, 2016
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
- Epstein-Barr Virus (EBV)
- Solid Organ Transplant (HCT)
- Hematopoietic Cell Transplant (SOT)
- Primary Immunodeficiency (PID)
- Acquired Immunodeficiency (AID)
- Epstein-Barr Virus-associated Lymphoma
- HIV/AIDS Lymphoma
- Rheumatoid Arthritis and Lymphoma
- Allogeneic, Off-The-Shelf T-cell Immunotherapy
- Tumor Necrosis Factor (TNF)-alpha Inhibitors and Lymphoma
- Inflammatory Bowel Disease and Lymphoma
- Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL)
- Epstein-Barr Virus+ associated Nasopharyngeal Carcinoma (EBV+ NPC)
- Epstein-Barr Virus+ associated Leiomyosarcoma (EBV+ LMS)
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Systemic Inflammatory Response Syndrome
- Inflammation
- Genetic Diseases, Inborn
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- DNA Virus Infections
- Sepsis
- Tumor Virus Infections
- Herpesviridae Infections
- Sarcoma
- Lymphoma, B-Cell
- Neoplasms, Muscle Tissue
- Nasopharyngeal Neoplasms
- Lymphoma
- Nasopharyngeal Carcinoma
- Virus Diseases
- Immunologic Deficiency Syndromes
- Primary Immunodeficiency Diseases
- Viremia
- Lymphoma, AIDS-Related
- Leiomyosarcoma
- Epstein-Barr Virus Infections
- Lymphoproliferative Disorders
Other Study ID Numbers
- ATA129-EAP-901
- EBV-CTL-201 (Other Identifier: Atara Biotherapeutics)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Atara BiotherapeuticsRecruitingLymphoproliferative Disorders | Leiomyosarcoma | Stem Cell Transplant Complications | Solid Organ Transplant Complications | Epstein-Barr Virus (EBV)-Associated Diseases | EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD) | Allogeneic Hematopoietic Cell Transplant | EBV+ Sarcomas | EBV+ Lymphoproliferative... and other conditionsUnited States, Austria, Belgium, France, Italy, Spain, United Kingdom
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