Phase 2
N=58
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
EBV-induced Lymphomas · EBV-associated Malignancies · Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00002663 ↗Enrolled (actual)
58
Serious AEs
69.0%
Results posted
Feb 2023
Primary outcome: Primary: Objective Response Rate (ORR) — 63.6; 50.0; 0; 43.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs) (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Atara Biotherapeutics
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
63.6; 50.0; 0; 43.5; 57.1 | — |
| SECONDARY Overall Survival (OS) |
14.8; 84.8; NA; 18.6; NA | — |
| SECONDARY OS Rate at 12 Months |
54.5; 75.0; 100.0; 52.2; 85.7 | — |
| SECONDARY OS Follow-up Time |
14.82; 63.56; 77.40; 18.63; 62.98 | — |
| SECONDARY Time to Response (TTR) |
1.18; 6.74; 1.45; 1.22 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
63.6; 75.0; 80.0; 47.8; 71.4 | — |
Summary
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
Eligibility Criteria
Inclusion Criteria
- Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma, or other EBV-associated malignancy OR
- Severely immunocompromised patients who develop blood levels of EBV DNA exceeding 500 copies/ml DNA, and are therefore at high risk for developing an EBV LPD
It is expected that five types of patients afflicted with EBV-associated lymphomas or lymphoproliferative diseases will be referred and will consent to participate in this trial. These are:
- Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic marrow transplant.
- Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant.
- Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV.
- Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy.
- Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and Non- Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma.
Exclusion Criteria
The following patients will be excluded from this study:
- Moribund patients who, by virtue of heart, kidney, liver, lung, or neurologic dysfunction not related to lymphoma, are unlikely to survive the 6-8 weeks required for in vitro generation and expansion of the EBV-specific T cells to be used for therapy and the subsequent 3 weeks required to achieve an initial assessment of the effects of infusions of EBV-specific T cells.
- Pregnancy does not constitute a contraindication to infusions of EBV-specific T cells.
Data sourced from ClinicalTrials.gov (NCT00002663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.