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

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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

Rituximab

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02900976 on ClinicalTrials.gov