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Rituximab for PTLD Prevention in Solid Organ Transplant Recipients With EBV DNAemia

NCT07614282 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-29

No results posted yet for this study

Summary

People who have received a solid organ transplant can develop ongoing Epstein-Barr virus (EBV) infection in the blood, which increases the risk of a serious cancer called post-transplant lymphoproliferative disorder (PTLD). This study will test whether rituximab, a drug approved by the U.S. Food and Drug Administration (FDA) for several immune-related conditions, can safely clear EBV from the blood and help prevent PTLD when lowering immune-suppressing medications is not possible or effective. The study includes an initial smaller group focused on determining whether EBV can be cleared, followed by a larger group designed to determine whether treatment lowers the risk of developing PTLD. Researchers will also monitor side effects, transplant organ health, and immune system changes to better understand treatment safety and benefit.

Conditions

  • PTLD
  • Epstein Barr Virus (EBV) Infection
  • Solid Organ Transplant

Interventions

DRUG

Rituximab

Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Participants will receive a single dose of 375 mg/m\^2 by intravenous administration.

Sponsors & Collaborators

  • Jennifer Amengual

    lead OTHER

Principal Investigators

  • Jennifer Amengual, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Drug
Yes

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Entities

Drugs

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 NCT07614282 on ClinicalTrials.gov