At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 58 enrolled
Drug / intervention
Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)biological
Likely dose
Not stated in record
Key inclusion· 6
- ✓Pathologically documented EBV antigen-positive lymphoproliferative disease, lymphoma, or other EBV-associated malignancy
- ✓Severely immunocompromised patients with blood EBV DNA levels exceeding 500 copies/ml, at high risk for developing EBV lymphoproliferative disease
- ✓Patients at risk for EBV disease following allogeneic bone marrow or organ transplant
- ✓Patients with AIDS-related EBV lymphomas or lymphoproliferative diseases
Key exclusion· 1
- ✕Moribund patients with heart, kidney, liver, lung, or neurologic dysfunction not related to lymphoma, unlikely to survive the 8-11 weeks required for EBV-CTL generation and initial treatment assessment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus-Immune T-Lymphocytes Derived From a Normal HLA-Compatible or Haplotype-Matched Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases or Malignancies and Patients With Detectable Circulating Levels of EBV DNA Who Are at High Risk for EBV-Associated Lymphoproliferative Diseases
In Brief
A Phase 2 clinical trial evaluating Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs) for EBV-induced Lymphomas and 2 related conditions. Completed, enrolled 58 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEBV-induced Lymphomas, EBV-associated Malignancies, Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
CountriesUnited States
Timeline
Phase 2CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 1995
First PostedJan 2003
Primary CompletionJul 2019
TodayJul 2026
First PostedJan 27, 2003
Enrollment StartMar 1, 1995
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 24.3 yearsPosted 23.4 years ago
Interventions
Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)biological
EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.