ClinicalTrials.gg
Not yet recruitingNCT07614282Updated Sep 17, 2026

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

A Phase 1 interventional study of Rituximab in PTLD, Epstein Barr Virus (EBV) Infection and Solid Organ Transplant, sponsored by Jennifer Amengual. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Jennifer Amengual · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies testing rituximab in Epstein-Barr Virus Infections — 4 open to participants now, 4 under way, none of them phase 3. Rituximab · Epstein-Barr Virus Infections.

Planned enrollment
5th of 10
28 · median 27
Started
2026
with 1 other
Phase 1
2 of 10
2 open now
Registered
9th of 10
by date
Lead sponsor
1 of 10
Jennifer Amengual

Among the 10 studies testing rituximab in Epstein-Barr Virus Infections, this one is the 5th largest by planned enrollment, is one of 2 that started in 2026, is one of 2 in phase 1, and was the 9th registered.

Epstein-Barr Virus Infections

175 studies on the registry are indexed under Epstein-Barr Virus Infections; 60 are open to participants now.

Browse Epstein-Barr Virus Infections studies →

Open to participants now

4 of the 10 studies testing rituximab in Epstein-Barr Virus Infections are open now, in 3 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

About rituximab

Rituximab: first FDA approval 1997 (RITUXAN), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 43 Epstein-Barr Virus Infections studies recruiting now, 23 (53%) set no upper age limit and 16 (37%) stop at 75 or younger; 23 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies testing rituximab in Epstein-Barr Virus Infections, or all of them as a file.
02

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.

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).

03

Conditions studied

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

Keywords

  • PTLD Prevention
  • Solid Organ Transplant
  • Rituximab
  • Epstein Barr Virus (EBV)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients must have received a solid organ transplant.
  2. Patients must not have a diagnosis of PTLD (confirmed with CT or PET imaging, and if there are concerning lesions present on imaging - a must be performed to rule out PTLD), or history of PTLD
  3. Age ≥ 18
  4. 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.
  5. Patients must have had reduction in their 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)
  6. Patients with a positive 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.
  7. Participants with a history of 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.
  8. Participants with known (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 checked within 28 days prior to registration, but may proceed with therapy regardless of CD4 count.
  9. Ability to understand and the willingness to sign a written 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.
  10. Must have a > 6 months
  11. Must not have an active 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.

Exclusion criteria

Exclusion criteria:

- Under the age of 18 years

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Rituximab

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

    Drug: Rituximab

Interventions

  • 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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jul 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2026
First posted
May 29, 2026
StartEst.
Dec 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07614282
Lead sponsor
Jennifer Amengual
Responsible party
Jennifer Amengual (Associate Professor of Medicine, Columbia University) — Sponsor-investigator
First posted
May 29, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Research Nurse Navigator
Contact
cancerclinicaltrials@cumc.columbia.edu
212-342-5162
Jennifer Amengual, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Rituximab

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