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

NCT07614282 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ACYY1399
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

PTLD Prevention; Solid Organ Transplant; Rituximab; Epstein Barr Virus (EBV)

Outcome Measures

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.

  6 months post-treatment

Study Arms (1)

Rituximab

EXPERIMENTAL

All participants enrolled to the treatment arm of the pilot study will receive 1 dose of rituximab.

Drug: Rituximab

Interventions

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.

Also known as: RITUXAN

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have had reduction in their immunosuppression according to institutional best practices prior to enrollment OR have documented clinical rationale for which immunosuppression may not be safely reduced (e.g. due to organ transplant rejection)
• Patients with a positive hepatitis B virus (HBV) core antibody and negative HBV surface antigen consistent with prior HBV exposure must be to take appropriate anti-viral prophylaxis. Patients with evidence of chronic HBV infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy.
• Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to consent.
• Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 28 days prior to registration). Participants with known HIV must have a CD4 count checked within 28 days prior to registration, but may proceed with therapy regardless of CD4 count.
• Ability to understand and the willingness to sign a written informed consent document. If an individual lacks capacity, a legally acceptable surrogate/legally authorized representative should be able to understand and willing to sign a written informed consent document.
• Must have a life expectancy \> 6 months
• Must not have an active malignancy unless in remission and with life expectancy \> 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma "in situ" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at CUIMC, and after consultation with the Principal Investigator. Hormone therapy for treated prostate and breast cancer is allowed.

You may not qualify if:

• \- Under the age of 18 years

Sponsors & Collaborators

• Jennifer Amengual: lead

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Infections

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jennifer Amengual, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162; cancerclinicaltrials@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05