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Epstein-Barr Virus-associated Lymphoproliferative DiseasesPhase 2NCT07381738

Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders

A Phase 2 study testing Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases in people with Epstein-Barr Virus-associated Lymphoproliferative Diseases and Chronic Active Epstein-Barr Virus Infection, run by Fudan University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial is designed as a single-arm, two-center, open-label, prospective study. All participants are enrolled in the standard-dose unrelated umbilical cord blood transplantation group to evaluate the efficacy and safety of unrelated umbilical cord blood transplantation in treating Epstein-Barr… Read more about this study

Who is it for?
Ages 14 to 80 years
What is being tested?
Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesChina
Study dates
1 Jan 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 14 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All subjects must meet all of the following criteria:
  • Age range: 14 to 80 years old, inclusive.
  • Diagnosed with an EBV-associated lymphoproliferative disease (including Chronic Active EBV Infection, EBV-associated Hemophagocytic Lymphohistiocytosis, and EBV-associated Lymphoma).
  • Meet at least one of the following disease-specific criteria (see below).
  • ECOG Performance Status score of 0-2 (or Lansky Play-Performance score ≥60 for children).
  • Expected survival of ≥3 months.
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  • Signed informed consent form (for minors, consent must be provided by a legal guardian).
  • Disease-Specific Inclusion Criteria:
  • CAEBV Patients: Patients diagnosed with CAEBV according to the 2016 revised WHO classification criteria, who also meet all of the following:
  • Persistent or recurrent infectious mononucleosis-like symptoms for more than 3 months.
  • Elevated EBV-DNA load in peripheral blood or involved tissues (peripheral blood EBV-DNA > 500 copies/ml).
  • Detection of EBV in T or NK cells (via EBER in situ hybridization or LMP1 immunohistochemistry).
  • Exclusion of other known immunodeficiency disorders, autoimmune diseases, or neoplastic diseases.
  • EBV-HLH Patients: Meet ≥5 of the HLH-2004 diagnostic criteria:
  • Persistent or recurrent infectious mononucleosis-like symptoms for more than 3 months.
  • Fever ≥38.5°C.
  • Splenomegaly.
  • Cytopenias (affecting ≥2 of 3 lineages):
  • Hb <90 g/L
  • PLT <100 × 10⁹/L
  • ANC <1.0 × 10⁹/L
  • Hypertriglyceridemia (>3 mmol/L) and/or hypofibrinogenemia (<1.5 g/L).
  • Serum ferritin >500 μg/L.
  • sCD25 >2400 U/mL.
  • Decreased or absent NK cell activity.
  • Evidence of hemophagocytosis in bone marrow, spleen, or lymph nodes.
  • EBV-associated Lymphoma Patients:
  • Pathologically confirmed diagnosis according to WHO criteria.
  • EBV-positive (EBER+).
  • Failure of or relapse after first-line therapy.
  • Exclusion Criteria:Patients meeting any of the following criteria will be excluded:
  • History of another primary malignancy within 5 years prior to the first treatment.
  • Uncorrected thyroid dysfunction.
  • Grade II or higher cardiac disease according to the New York Heart Association (NYHA) classification.
  • History of organ transplantation.
  • Planned to receive other types of hematopoietic stem cell transplantation during the study period.
  • Active infections, including:
  • Active hepatitis B or hepatitis C.
  • Positive serum HIV antigen or antibody.
  • History of syphilis.
  • Major surgery within 4 weeks prior to the first treatment, or anticipated need for major surgery during the study.
  • Pregnant or breastfeeding women.
  • History of severe psychiatric illness or substance abuse.
  • High risk of complications, such as:
  • Uncontrolled infection.
  • Active major visceral hemorrhage.
  • Known allergy to any component of the investigational drug(s), or a history of severe allergies.
  • Patients deemed unable to comply with the study procedures and/or follow-up requirements.
  • -

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jiexian Ma contact

+86 13764520566

jiexianma@hotmail.com

China2 sites, 2 recruiting

  • Huadong hospital, Fudan university

    Shanghai, Shanghai Municipality, 200040

    Jiexian Ma, +8613764520566, jiexianma@hotmail.com

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Lingyun Shao, +8613916900780

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Two-center, Prospective Clinical Study of Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders

This clinical trial is designed as a single-arm, two-center, open-label, prospective study. All participants are enrolled in the standard-dose unrelated umbilical cord blood transplantation group to evaluate the efficacy and safety of unrelated umbilical cord blood transplantation in treating Epstein-Barr virus-associated lymphoproliferative disease.

Read the detailed description

Epstein-Barr virus-associated lymphoproliferative diseases (EBV-LPDs) are a group of disorders characterized by abnormal proliferation of lymphocytes caused by or associated with Epstein-Barr virus (EBV) infection.

Among these, chronic active EBV infection (CAEBV) is a severe systemic EBV-positive lymphoproliferative disease predominantly seen in East Asian populations, especially in Japan, China, and Korea. Unlike in Western countries where B cells are primarily affected, EBV in Asian CAEBV patients mainly infects T cells or NK cells. The clinical manifestations of CAEBV are diverse, including fever, hepatosplenomegaly, lymphadenopathy, rash, and hypersensitivity to mosquito bites. Serious complications include hemophagocytic lymphohistiocytosis (HLH), liver failure, interstitial pneumonia, and coronary artery lesions. Current treatment strategies for CAEBV include immunomodulatory therapy, chemotherapy (including etoposide-containing regimens such as L-DEP, CHOP, etc.), and allogeneic hematopoietic stem cell transplantation. Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is currently the only potentially curative approach. Patients with severe CAEBV have an extremely poor prognosis without undergoing hematopoietic stem cell transplantation.

EBV-associated lymphomas refer to a category of malignant lymphoid neoplasms driven or implicated in pathogenesis by EBV infection. By infecting B cells, T cells, or NK cells, EBV leads to abnormal cell proliferation and malignant transformation, ultimately resulting in lymphoma. EBV-associated lymphomas are highly heterogeneous, necessitating precise stratification of treatment regimens. For high-risk and refractory EBV-associated lymphomas, allogeneic hematopoietic stem cell transplantation is an effective treatment method.

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is a therapeutic procedure that involves the infusion of hematopoietic stem cells from a healthy donor to reconstitute the patient's hematopoietic and immune systems. Numerous international studies have demonstrated that Allo-HSCT is an effective treatment for various EBV-LPDs. Umbilical cord blood transplantation (UCBT) is a specific type of Allo-HSCT. Umbilical cord blood refers to the blood remaining in the umbilical cord and placenta after the cord of a newborn is clamped. This blood is rich in hematopoietic stem cells, and transplantation using this cord blood is termed umbilical cord blood hematopoietic stem cell transplantation.

Given that both the Chinese Expert Consensus on the Diagnosis and Treatment of Chronic Active EBV Disease and international CAEBV management consensuses indicate that Allo-HSCT is currently the only potentially curative method for CAEBV, and considering that internationally published small-sample studies have shown favorable efficacy of UCBT in EBV-LPDs such as CAEBV, data across different disease subtypes remain limited. Therefore, this study aims to further validate the efficacy and safety of unrelated umbilical cord blood transplantation for EBV-associated lymphoproliferative diseases through a single-center, prospective investigation.

Being tested
Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases
Keywords
Epstein-Barr virus-associated lymphoproliferative diseases, Chronic Active Epstein-Barr Virus Infection, EBV Associated Lymphoma, Umbilical Cord Blood Transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseasesProcedure or surgery

    All participants will be enrolled in the treatment group and will receive a standard-dose unrelated cord blood transplantation. The efficacy and safety of unrelated cord blood transplantation for the treatment of Epstein-Barr virus-associated lymphoproliferative diseases will be evaluated.

Study groups in NCT07381738
Study groupRoleWhat they receive
Treatment armExperimentalAll participants will be enrolled in the treatment group and will receive a standard-dose unrelated cord blood transplantation. The efficacy and safety of unrelated cord blood transplantation for the treatment of Epstein-Barr virus-associated lymphoproliferative diseases will be evaluated.
Receives: Procedure: Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    The percentage of patients who achieved complete response (CR) or partial response (PR) after umbilical cord blood transplantation, out of the total number of patients evaluable for efficacy.

    Measured: 3 months

Secondary outcomes (2)

  1. Survival

    From the date of inclusion to date of death, irrespective of cause Adverse Events

    Measured: 1 year

  2. Treatment-Related Adverse Events

    Adverse events including myelosuppression, liver function damage, infection, bleeding and so on.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381738
Sponsor's protocol ID
2025K399
Status last verified
Jan 2026
First submitted
20 Jan 2026
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases in people with Epstein-Barr Virus-associated Lymphoproliferative Diseases and Chronic Active Epstein-Barr Virus Infection, run by Fudan University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 49 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiexian Ma (+86 13764520566, jiexianma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07381738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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