Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT02822495
Eligibility Criteria:
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
Sex:
ALL
Study:
NCT02822495
Study Brief:
Protocol Section:
NCT02822495