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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJennifer Amengual

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have received a solid organ transplant.

Patients must not have a diagnosis of PTLD (confirmed with CT or PET imaging, and if there are concerning lesions present on imaging - a biopsy must be performed to rule out PTLD), or history of PTLD

Age ≥ 18

Patients must have EBV DNAemia ≥ 1000 IU/mL (plasma) on two consecutive measurements at least 1 week apart and within a 6-week period. The second measurement must be within 4 weeks of enrollment.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Rituximab

    Drug

    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.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: RituximabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clearance of EBV DNAemia

Evaluate the efficacy of rituximab for clearance of EBV DNAemia in solid organ transplant recipients as measured by complete response (CR) rate at 6 months post-rituximab. CR is defined as resolution of viremia below the limit of detection.

Time frame
6 months post-treatment

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Amengual

Lead sponsor

Columbia University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: