Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder
NCT02900976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-01-26
Summary
This pilot phase II trial studies how well rituximab and latent membrane protein (LMP)-specific T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive, cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. LMP-specific T-cells are special immune system cells trained to recognize proteins found on post-transplant lymphoproliferative disorder tumor cells if they are infected with Epstein-Barr virus. Giving rituximab and LMP-specific T-cells may work better in treating pediatric organ recipients with post-transplant lymphoproliferative disorder than rituximab alone.
Conditions
- EBV-Related Post-Transplant Lymphoproliferative Disorder
- Monomorphic Post-Transplant Lymphoproliferative Disorder
- Polymorphic Post-Transplant Lymphoproliferative Disorder
- Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder
- Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder
- Refractory Monomorphic Post-Transplant Lymphoproliferative Disorder
- Refractory Polymorphic Post-Transplant Lymphoproliferative Disorder
Interventions
- BIOLOGICAL
-
Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes
Given IV
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Children's Oncology Group
lead NETWORK
Principal Investigators
-
Birte Wistinghausen · Children's Oncology Group
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 29 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-22
- Primary Completion
- 2021-03-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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