PTLDPhase 1NCT07614282
Rituximab for PTLD Prevention in Solid Organ Transplant Recipients With EBV DNAemia
A Phase 1 study testing Rituximab in people with PTLD and Epstein Barr Virus (EBV) Infection, run by Jennifer Amengual.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTLD, Epstein Barr Virus (EBV) Infection, Solid Organ Transplant
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jul 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Under the age of 18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Trial of Rituximab in Addition to Standard of Care for the Prevention of Post-Transplant Lymphoproliferative Disorder in Solid Organ Transplant Recipients With EBV DNAemia
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.
Read the detailed description
Solid organ transplant recipients with persistent Epstein-Barr virus (EBV) DNAemia are at increased risk for post-transplant lymphoproliferative disorder (PTLD), and optimal preemptive management remains undefined. This Phase 1 study evaluates the efficacy and safety of rituximab in this population, with primary endpoints of EBV DNAemia clearance at 6 months. All participants will receive a single dose of intravenous rituximab (375 mg/m^2).
- Being tested
- Rituximab
- Keywords
- PTLD Prevention, Solid Organ Transplant, Rituximab, Epstein Barr Virus (EBV)
- Medical subject headings
- Epstein-Barr Virus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called RITUXAN
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.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | All participants enrolled to the treatment arm of the pilot study will receive 1 dose of rituximab. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startDec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Amengual
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Amengual, Columbia University
- Investigators
- Jennifer Amengual, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614282
- Sponsor's protocol ID
- ACYY1399
- Status last verified
- Sep 2026
- First submitted
- 22 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided