Unrelated umbilical cord blood transplant for EBV-associated lymphoproliferative diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, two-center, open-label prospective Phase 2 trial in which all participants receive a standard-dose unrelated umbilical cord blood transplantation to treat EBV-associated lymphoproliferative diseases. The trial enrolls adolescents and adults with diagnoses such as chronic active EBV infection, EBV-associated hemophagocytic lymphohistiocytosis, or EBV-associated lymphoma and requires adequate performance status and expected survival. The primary focus is on safety and efficacy outcomes following cord blood transplantation in patients who may lack matched donors, with close monitoring of EBV-DNA levels, graft function, and transplant-related complications. The procedures and follow-up are conducted at two Fudan University hospitals in Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:General Inclusion Criteria:

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.

Signed informed consent form (for minors, consent must be provided by a legal guardian).

Disease-Specific Inclusion Criteria:

A. 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.

B. 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.

C. 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.

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Where it's running

• Huadong hospital, Fudan university
  Shanghai, Shanghai Municipality, China Recruiting
• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jiexian Ma — Huadong Hospital
• Study coordinator: Jiexian Ma
• Email: jiexianma@hotmail.com
• Phone: +86 13764520566

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Genetic analysis of Chronic Active Epstein-Barr Virus

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• Epstein-Barr virus–positive T/NK-cell lymphoproliferative diseases in large patient groups

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• Using Romiplostim N01 to help platelet recovery after umbilical cord blood transplantation

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• Using Avatrombopag to Help Platelet Recovery After Cord Blood Transplantation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.