Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder

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

Eligibility Criteria

Sex

ALL

Age

N/A - 29 Years

Healthy Volunteers

Not accepted

Interventions

• Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes — BIOLOGICAL
  Given IV
• Rituximab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Mar 22, 2017

Status verified

Jan 2026

Primary completion

Mar 31, 2021

Completion

Dec 31, 2025

Study Design

Enrollment

18 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (RTX)
  Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction.
• Experimental: Arm II (LMP-TC)
  Patients with newly diagnosed PTLD who do not achieve a CR to induction, all relapsed patients after induction, and all patients with refractory disease who received rituximab or biosimilar within 90 days according to institutional guidelines, receive allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes IV over 1- 2 minutes on days 0 and 7. Cycle continues for up to 42 days in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after first cycle of cycle allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes receive an additional cycle.

Primary Outcome Measure

Percentage of Patients Assigned to Arm Latent Membrane Protein-specific T-cells (LMP-TC) With Successful LMP-specific T Cell Product Match, Were Treated Within Two Weeks of the Expected Start Date, and Received Both Weekly Doses [ Time Frame: Day 8 of the first LMP-TC cycle (cycle = 42 days) ]

Locations (38)

Find similar trials in Birmingham, AL

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